A Phase 1 interventional study of SEA-BCMA and dexamethasone in Multiple Myeloma, sponsored by Seagen Inc.. Terminated at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Seagen Inc. (part of Pfizer) · Phase 1, Interventional, and Treatment
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.
The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.
In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 83 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Seagen Inc. is the lead sponsor of 88 studies on the registry; 1 is open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 14 (52%) have results posted.
First submitted before Seagen Inc. became part of Pfizer.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Combination therapy only:
SEA-BCMA
Drug: SEA-BCMA
SEA-BCMA + dexamethasone
Drug: SEA-BCMA · Drug: dexamethasone
SEA-BCMA + dexamethasone + pomalidomide
Drug: SEA-BCMA · Drug: dexamethasone · Drug: pomalidomide
Given into the vein (IV; intravenously)
Given by mouth (orally) or by IV
Given orally
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Number of Participants With Dose Limiting Toxicities (DLTs): Part A
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the safety monitoring committee (SMC) to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Number of Participants With DLTs: Part B
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Number of Participants With DLTs: Part C
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Number of Participants With DLTs: Part D
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 14 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1
Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
AUC0-7 of SEA-BCMA: Part B
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
AUC0-7 of SEA-BCMA: Part C
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
AUC0-7 of SEA-BCMA: Part D
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A
Time frame: Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Cmax of SEA-BCMA: Part B
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Cmax of SEA-BCMA: Part C
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Cmax of SEA-BCMA: Part D
Time frame: Cycle 1:Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 45 months)
Number of Participants With SEA-BCMA, ATA: Part B
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 34 months)
Number of Participants With SEA-BCMA, ATA: Part C
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 37 months)
Number of Participants With SEA-BCMA, ATA: Part D
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 20 months)
Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A
ORR: Percentage of participants with an objective response (OR) per investigator. Participant was determined to have an OR if, based on 2016 IMWG uniform response criteria, \& achieved stringent complete response (sCR), Complete response (CR), very good partial response(VGPR) \& partial response(PR): free light chain(FLC) ratio \& absence of clonal cells in bone marrow by immunohistochemistry(IC)/ immunofluorescence(IF). CR: negative immunofixation of serum \& urine, disappearance of any soft tissue plasmacytomas(STP), 5% plasma cells in bone marrow. VGPR: serum \& urine M-protein (UMP) detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in serum M-protein (SMP) level+UMP level \<100 mg/24 hr, PR: \>=50% reduction of SMP \& reduction in 24-hr urinary M-protein by \>=90%/to \<200 mg/24 hr. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
ORR as Per the IMWG Uniform Response Criteria: Part B
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34 months)
ORR as Per the IMWG Uniform Response Criteria: Part C
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 37 months)
ORR as Per the IMWG Uniform Response Criteria: Part D
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD \& PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD \& PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34 months)
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD \& PD per 2016 IMWG. MRD: evaluated using NGS for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 37 months)
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD \& PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months)
DOR as Per the IMWG Uniform Response Criteria: Part B
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 34 months)
DOR as Per the IMWG Uniform Response Criteria: Part C
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months)
DOR as Per the IMWG Uniform Response Criteria: Part D
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 20 months)
Progression Free Survival (PFS): Part A
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months)
PFS: Part B
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 34 months)
PFS: Part C
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 37 months)
PFS: Part D
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 20 months)
Overall Survival (OS): Part A
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 45 months)
OS: Part B
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 34 months)
OS: Part C
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 37 months)
OS: Part D
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 20 months)
A total of 106 participants signed the informed consent form. 15 participants were screen failures, 8 were not assigned to receive study treatment and 83 participants received at least 1 dose of study treatment.
| Milestone | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 7 | 22 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 2 | 2 | 2 | 7 | 22 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 1 | 1 | 2 | 4 | 11 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 1 | 7 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 |
| Milestone | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 6 | 5 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 6 | 5 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 1 | 2 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 |
| Milestone | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
| Participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| TEAEs | 2 | 2 | 2 | 6 | 20 |
| TESAEs | 1 | 1 | 2 | 3 | 8 |
| Treatment Related TEAEs | 0 | 0 | 1 | 4 | 13 |
| TEAEs (>= Grade 3) | 1 | 1 | 2 | 4 | 13 |
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
| Participants | Part B: SEA-BCMA 1600mg |
|---|---|
| TEAEs | 19 |
| TESAEs | 5 |
| Treatment Related TEAEs | 7 |
| TEAEs (>= Grade 3) | 6 |
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
| Participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| TEAEs | 11 | 6 | 5 |
| TESAEs | 5 | 3 | 2 |
| Treatment Related TEAEs | 4 | 0 | 3 |
| TEAEs (>= Grade 3) | 8 | 5 | 3 |
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
| Participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| TEAEs | 5 |
| TESAEs | 3 |
| Treatment Related TEAEs | 3 |
| TEAEs (>= Grade 3) | 3 |
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Grade 1 | 0 | 1 | 0 | 1 | 4 |
| Grade 2 | 0 | 0 | 0 | 3 | 7 |
| Grade 3 | 0 | 1 | 2 | 2 | 11 |
| Grade 4 | 2 | 0 | 0 | 1 | 0 |
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part B: SEA-BCMA 1600mg |
|---|---|
| Grade 1 | 5 |
| Grade 2 | 8 |
| Grade 3 | 6 |
| Grade 4 | 1 |
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| Grade 1 | 0 | 1 | 1 |
| Grade 2 | 5 | 1 | 2 |
| Grade 3 | 5 | 3 | 2 |
| Grade 4 | 2 | 1 | 0 |
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| Grade 1 | 1 |
| Grade 2 | 1 |
| Grade 3 | 3 |
| Grade 4 | 0 |
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Grade 1 | 0 | 1 | 1 | 0 | 0 |
| Grade 2 | 0 | 0 | 0 | 1 | 12 |
| Grade 3 | 1 | 1 | 1 | 4 | 9 |
| Grade 4 | 1 | 0 | 0 | 2 | 1 |
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part B: SEA-BCMA 1600mg |
|---|---|
| Grade 1 | 6 |
| Grade 2 | 6 |
| Grade 3 | 7 |
| Grade 4 | 1 |
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| Grade 1 | 1 | 1 | 1 |
| Grade 2 | 3 | 3 | 0 |
| Grade 3 | 4 | 2 | 3 |
| Grade 4 | 4 | 0 | 1 |
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
| Participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| Grade 1 | 0 |
| Grade 2 | 2 |
| Grade 3 | 1 |
| Grade 4 | 2 |
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the safety monitoring committee (SMC) to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
| Participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs): Part A | 0 | 0 | 0 | 1 | 0 |
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
| Participants | Part B: SEA-BCMA 1600mg |
|---|---|
| Number of Participants With DLTs: Part B | 0 |
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
| Participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| Number of Participants With DLTs: Part C | 0 | 0 | 0 |
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
| Participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| Number of Participants With DLTs: Part D | 0 |
Area under the observed concentration-time curve from the time of dosing to Day 14 calculated by log-linear trapezoidal approximation.
| Day*micrograms per milliliter (ug/mL) | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Cycle 1 | 181.3 ± 20.0 | 302.6 ± 14.6 | 977.2 ± 37.0 | 1443.2 ± 23.9 | 3267.7 ± 26.8 |
| Cycle 2 | 244.8 ± 15.4 | 436.0 ± 10.6 | 2216.4 ± NA | 2387.9 ± 41.4 | 5972.1 ± 61.0 |
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
| Day*ug/mL | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | 112.6 ± 17.6 | 197.6 ± 11.1 | 626.5 ± 26.3 | 932.0 ± 22.1 | 2064.5 ± 23.4 |
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
| Day*ug/mL | Part B: SEA-BCMA 1600mg |
|---|---|
| AUC0-7 of SEA-BCMA: Part B | 2001.3 ± 26.4 |
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
| Day*ug/mL | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| AUC0-7 of SEA-BCMA: Part C | 2011.8 ± 32.9 | 840.3 ± 21.2 | 1629.3 ± 20.9 |
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
| Day*ug/mL | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| AUC0-7 of SEA-BCMA: Part D | 1926.2 ± NA |
| Micrograms per milliliter (ug/mL) | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Cycle 1 | 28.5 ± 32.3 | 47.2 ± 3.9 | 134.8 ± 11.6 | 236.4 ± 14.4 | 494.6 ± 20.3 |
| Cycle 2 | 44.9 ± 3.6 | 62.4 ± NA | 213.1 ± NA | 307.4 ± 34.1 | 746.6 ± 29.7 |
| ug/mL | Part B: SEA-BCMA 1600mg |
|---|---|
| Cmax of SEA-BCMA: Part B | 493.3 ± 27.7 |
| ug/mL | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| Cmax of SEA-BCMA: Part C | 471.5 ± 72.3 | 204.2 ± 27.3 | 486.4 ± 17.9 |
| ug/mL | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| Cmax of SEA-BCMA: Part D | 415.1 ± 31.8 |
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
| Participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | 0 | 0 | 0 | 0 | 0 |
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
| Participants | Part B: SEA-BCMA 1600mg |
|---|---|
| Number of Participants With SEA-BCMA, ATA: Part B | 0 |
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
| Participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| Number of Participants With SEA-BCMA, ATA: Part C | 0 | 0 | 0 |
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
| Participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| Number of Participants With SEA-BCMA, ATA: Part D | 0 |
ORR: Percentage of participants with an objective response (OR) per investigator. Participant was determined to have an OR if, based on 2016 IMWG uniform response criteria, \& achieved stringent complete response (sCR), Complete response (CR), very good partial response(VGPR) \& partial response(PR): free light chain(FLC) ratio \& absence of clonal cells in bone marrow by immunohistochemistry(IC)/ immunofluorescence(IF). CR: negative immunofixation of serum \& urine, disappearance of any soft tissue plasmacytomas(STP), 5% plasma cells in bone marrow. VGPR: serum \& urine M-protein (UMP) detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in serum M-protein (SMP) level+UMP level \<100 mg/24 hr, PR: \>=50% reduction of SMP \& reduction in 24-hr urinary M-protein by \>=90%/to \<200 mg/24 hr. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria.
| Percentage of participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 0 (0.0 to 84.2) | 0 (0.0 to 84.2) | 0 (0.0 to 84.2) | 0 (0.0 to 41.0) | 14 (2.9 to 34.9) |
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
| Percentage of participants | Part B: SEA-BCMA 1600mg |
|---|---|
| ORR as Per the IMWG Uniform Response Criteria: Part B | 20 (5.7 to 43.7) |
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
| Percentage of participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| ORR as Per the IMWG Uniform Response Criteria: Part C | 17 (2.1 to 48.4) | 33 (4.3 to 77.7) | 20 (0.5 to 71.6) |
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum \& urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP \& reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP \& UMP are unmeasurable, a ≥50% decrease in the difference between involved \& uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
| Percentage of participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| ORR as Per the IMWG Uniform Response Criteria: Part D | 80 (28.4 to 99.5) |
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD \& PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
| Percentage of participants | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Minimal Residual Disease (MRD)-negative complete response (CR) | 0 | 0 | 0 | 0 | 0 |
| Stringent complete response (sCR) | 0 | 0 | 0 | 0 | 0 |
| Complete response (CR) | 0 | 0 | 0 | 0 | 0 |
| Very good partial response (VGPR) | 0 | 0 | 0 | 0 | 5 |
| Partial response (PR) | 0 | 0 | 0 | 0 | 9 |
| Minimal response (MR) | 0 | 0 | 0 | 0 | 5 |
| Stable disease (SD) | 50 | 100 | 0 | 86 | 45 |
| Progressive disease (DP) | 50 | 0 | 100 | 14 | 36 |
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD \& PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
| Percentage of participants | Part B: SEA-BCMA 1600mg |
|---|---|
| MRD-negative CR | 0 |
| sCR | 5 |
| CR | 0 |
| VGPR | 0 |
| PR | 15 |
| MR | 5 |
| SD | 55 |
| DP | 15 |
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD \& PD per 2016 IMWG. MRD: evaluated using NGS for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
| Percentage of participants | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| MRD-negative CR | 0 | 0 | 0 |
| sCR | 8 | 0 | 0 |
| CR | 0 | 0 | 0 |
| VGPR | 0 | 17 | 0 |
| PR | 8 | 17 | 20 |
| MR | 0 | 17 | 0 |
| SD | 67 | 33 | 60 |
| DP | 17 | 17 | 20 |
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD \& PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR \& normal FLC ratio \& absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum \& urine disappearance of any STP, \& \<5% plasma cells in bone marrow. VGPR: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
| Percentage of participants | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| MRD-negative CR | 0 |
| sCR | 40 |
| CR | 0 |
| VGPR | 20 |
| PR | 20 |
| MR | 0 |
| SD | 20 |
| DP | 0 |
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
| Months | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A | — | — | — | — | 10.0 (5.5 to 15.2) |
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
| Months | Part B: SEA-BCMA 1600mg |
|---|---|
| DOR as Per the IMWG Uniform Response Criteria: Part B | 8.4 (1.8 to 31.5) |
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
| Months | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| DOR as Per the IMWG Uniform Response Criteria: Part C | NA (4.6 to 35.7) | NA (1.9 to 22.6) | 6.5 (6.5 to 6.5) |
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
| Months | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| DOR as Per the IMWG Uniform Response Criteria: Part D | 8.3 (2.6 to 18.9) |
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
| Months | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Progression Free Survival (PFS): Part A | 1.7 (0.7 to 2.8) | 5.9 (0.7 to 11.0) | 0.7 (0.7 to 0.7) | 4.4 (0.6 to 15.5) | 2.1 (0.5 to 42.9) |
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
| Months | Part B: SEA-BCMA 1600mg |
|---|---|
| PFS: Part B | 1.7 (0.5 to 33.1) |
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
| Months | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| PFS: Part C | 1.6 (0.7 to 36.4) | 3.2 (0.7 to 24.1) | 3.5 (0.7 to 7.2) |
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
| Months | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| PFS: Part D | 10.1 (1.8 to 19.6) |
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
| Months | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg |
|---|---|---|---|---|---|
| Overall Survival (OS): Part A | 9.2 (3.0 to 9.2) | 37.5 (11.1 to 37.5) | 8.1 (0.9 to 15.3) | 19.2 (1.3 to 45.3) | 19.7 (0.9 to 44.3) |
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
| Months | Part B: SEA-BCMA 1600mg |
|---|---|
| OS: Part B | NA (0.8 to 33.7) |
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
| Months | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone |
|---|---|---|---|
| OS: Part C | 18.0 (1.9 to 36.4) | NA (3.7 to 26.0) | 12.2 (1.2 to 22.2) |
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
| Months | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|
| OS: Part D | NA (3.3 to 19.6) |
Collected over From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment for Part A: up to 44 months (maximum follow up of 45 months); Part B: up to 33 months (maximum follow up of 34 months); Part C: up to 36 months (maximum follow up of 37 months) and Part D: up to 19 months (maximum follow up of 20 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| Part A: SEA-BCMA 200mg | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| Part A: SEA-BCMA 400mg | 2/2 (100%) | 2/2 (100%) | 2/2 (100%) |
| Part A: SEA-BCMA 800mg | 4/7 (57.1%) | 3/7 (42.9%) | 6/7 (85.7%) |
| Part A: SEA-BCMA 1600mg | 11/22 (50%) | 8/22 (36.4%) | 18/22 (81.8%) |
| Part B: SEA-BCMA 1600mg | 2/20 (10%) | 5/20 (25%) | 17/20 (85%) |
| Part C: SEA-BCMA 1600mg and Dexamethasone | 6/12 (50%) | 5/12 (41.7%) | 10/12 (83.3%) |
| Part C: SEA-BCMA 800mg and Dexamethasone | 1/6 (16.7%) | 3/6 (50%) | 5/6 (83.3%) |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 2/5 (40%) | 2/5 (40%) | 5/5 (100%) |
| Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | 1/5 (20%) | 3/5 (60%) | 5/5 (100%) |
| Event | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|---|---|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 1/2 | 0/2 | 1/2 | 0/7 | 0/22 | 1/20 | 3/12 | 0/6 | 1/5 | 1/5 |
| Septic shockInfections and infestations | 1/2 | 0/2 | 0/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| FallInjury, poisoning and procedural complications | 0/2 | 0/2 | 1/2 | 0/7 | 2/22 | 0/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/2 | 0/2 | 1/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/2 | 0/2 | 0/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/2 | 1/2 | 0/2 | 0/7 | 0/22 | 1/20 | 0/12 | 1/6 | 0/5 | 0/5 |
| NeutropeniaBlood and lymphatic system disorders | 0/2 | 0/2 | 0/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 1/5 |
| Atrial fibrillationCardiac disorders | 0/2 | 0/2 | 0/2 | 0/7 | 0/22 | 0/20 | 0/12 | 1/6 | 0/5 | 1/5 |
| Cystic fibrosisCongenital, familial and genetic disorders | 0/2 | 0/2 | 0/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 1/5 | 0/5 |
| Cholelithiasis obstructiveHepatobiliary disorders | 0/2 | 0/2 | 0/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 1/5 |
| Event | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone |
|---|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/2 | 0/2 | 2/2 | 0/7 | 2/22 | 0/20 | 3/12 | 1/6 | 1/5 | 1/5 |
| DiarrhoeaGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 0/7 | 3/22 | 3/20 | 1/12 | 1/6 | 3/5 | 2/5 |
| AnaemiaBlood and lymphatic system disorders | 1/2 | 0/2 | 0/2 | 2/7 | 3/22 | 0/20 | 5/12 | 0/6 | 1/5 | 0/5 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/2 | 0/2 | 0/2 | 1/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| Abdominal painGastrointestinal disorders | 1/2 | 0/2 | 0/2 | 0/7 | 1/22 | 0/20 | 1/12 | 0/6 | 0/5 | 0/5 |
| HaemorrhoidsGastrointestinal disorders | 0/2 | 0/2 | 1/2 | 0/7 | 0/22 | 0/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| Facial painGeneral disorders | 0/2 | 1/2 | 0/2 | 0/7 | 0/22 | 1/20 | 0/12 | 0/6 | 0/5 | 0/5 |
| FatigueGeneral disorders | 0/2 | 1/2 | 0/2 | 2/7 | 8/22 | 7/20 | 6/12 | 1/6 | 2/5 | 2/5 |
| Oedema peripheralGeneral disorders | 0/2 | 1/2 | 0/2 | 1/7 | 1/22 | 2/20 | 1/12 | 0/6 | 0/5 | 2/5 |
| PyrexiaGeneral disorders | 0/2 | 0/2 | 1/2 | 1/7 | 4/22 | 1/20 | 2/12 | 0/6 | 1/5 | 0/5 |
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Age, Continuous(Years) | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 68.5 ± 2.1 | 70.0 ± 7.1 | 72.5 ± 9.2 | 64.3 ± 10.6 | 73.3 ± 7.9 | 73.2 ± 8.9 | 66.9 ± 8.5 | 74.3 ± 6.5 | 72.6 ± 3.9 | 71.2 ± 6.6 | 71.3 ± 8.3 |
| Sex: Female, Male(Participants) | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 0 | 2 | 2 | 10 | 7 | 7 | 2 | 2 | 2 | 36 |
| Male | 0 | 2 | 0 | 5 | 12 | 13 | 5 | 4 | 3 | 3 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 3 | 0 | 2 | 1 | 1 | 1 | 9 |
| Not Hispanic or Latino | 2 | 2 | 2 | 6 | 18 | 19 | 10 | 5 | 4 | 4 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 0 | 3 | 1 | 2 | 3 | 0 | 1 | 0 | 13 |
| White | 0 | 1 | 2 | 4 | 19 | 17 | 9 | 6 | 3 | 5 | 66 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
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Ran from Nov 2018 to primary completion in Nov 2023, 60 months.
Results were first posted in Dec 2024, 1 year 1 month after primary completion.
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