A Phase 1/2 interventional study of Belantamab mafodotin and Feladilimab in Multiple Myeloma, sponsored by GlaxoSmithKline. Active, not recruiting at 11 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with feladilimab (GSK3359609), and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
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Exclusion Criteria:
For participants receiving nirogacestat, HIV drugs that are strong Cytochrome P450 3A4 (CYP3A4) inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while permitted, should be co-administered with caution and must be accompanied by nirogacestat dose modifications.
Drug: Belantamab mafodotin · Drug: Feladilimab
Belantamab mafodotin will be administered.
Also known as: GSK2857916
Feladilimab will be administered.
Also known as: GSK3359609
Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLTs)
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLT severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Time frame: Up to 28 days
DE Phase: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to approximately 281 weeks
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of hematology parameters including Anemia, Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and up to approximately 281 weeks.
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia (HypoG), hypoalbuminemia (HypoA), creatine kinase increased (CPKI), hyperkalemia, blood lactate dehydrogenase increased (LDHI), hypermagnesemia (HyperM), hypomagnesemia (HypoM), hypernatremia (HyperN), hypercalcemia (HyperC), hypocalcemia (HypoC) and chronic kidney disease (CKD). ). The laboratory parameters were graded according to CTCAE v 5.0. G1: mild; G2: moderate; G3: severe; G4: life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented. The laboratory parameters were graded according to CTCAE v 5.0.
Time frame: Baseline (Day 1) and up to approximately 281 weeks.
Cohort Expansion (CE) Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Time frame: Up to approximately 281 weeks.
DE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Time frame: Up to approximately 281 weeks.
CE Phase: Clinical Benefit Rate (CBR)
Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Time frame: Up to approximately 281 weeks.
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Time frame: Up to approximately 281 weeks.
CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Time frame: Up to approximately 281 weeks.
DE Phase: Plasma Concentration of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Time frame: Predose, end of infusion (EOI), 2 and 24 hours postdose on Cycle (C) 1 Day (D) 1; anytime sample at C1 D4 and D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at end of treatment (EoT, up to approximately 281 weeks.)
CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were planned to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC).
Time frame: Up to approximately 281 weeks.
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
Time frame: Predose, EOI, 2 and 24 hours postdose on C1 D1, anytime sample at C1 D4, D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at EoT (up to approximately 281 weeks.)
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
Blood samples were planned to be collected for PK analysis of Belantamab mafodotin plasma total antibody.
Time frame: Up to approximately 281 weeks.
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
Time frame: Predose, EOI, 2 and 24 hours postdose on C1 D1, anytime sample at C1 D4, D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at EoT (up to approximately 281 weeks)
CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were planned to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Time frame: Up to approximately 281 weeks.
DE Phase: Feladilimab Concentration When Administered in Combination With Belantamab Mafodotin
Blood samples were collected for PK analysis of Feladilimab when administered intravenously in combination with belantamab mafodotin.
Time frame: Predose, EOI, 2 and 24 hours postdose on C1 D1, anytime sample at C1 D4, D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at EoT (up to approximately 281 weeks)
CE Phase: Feladilimab Concentration When Administered in Combination With Belantamab Mafodotin
Blood samples were planned to be collected for PK analysis Feladilimab when administered intravenously in combination with belantamab mafodotin.
Time frame: Up to approximately 281 weeks.
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to approximately 281 weeks
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 281 weeks
DE Phase: Titer of ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to approximately 281 weeks
CE Phase: Titer of ADAs Against Belantamab Mafodotin
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 281 weeks
DE Phase: Number of Participants With Post-baseline Positive ADAs Against Feladilimab
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 281 weeks
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Feladilimab
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to approximately 281 weeks.
DE Phase: Titre of ADAs Against Feladilimab
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to approximately 281 weeks
CE Phase: Titer of ADAs Against Feladilimab
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to approximately 281 weeks.
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
Time frame: Up to approximately 281 weeks.
CE Phase: Number of Participants With AESI
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were planned to be collected.
Time frame: Up to approximately 281 weeks.
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.
Time frame: Up to approximately 281 weeks.
CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.
Time frame: Up to approximately 281 weeks.
CE Phase: Progression-free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
Time frame: Up to approximately 281 weeks.
CE Phase: Duration of Response (DoR)
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
Time frame: Up to approximately 281 weeks.
CE Phase: Time to Response (TTR)
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
Time frame: Up to approximately 281 weeks.
CE Phase: Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: Up to approximately 281 weeks.
CE Phase: Number of Participants With AEs and SAEs
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to approximately 281 weeks.
CE Phase: Number of Participants With AEs Leading to Discontinuation
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to discontinuation were to be evaluated.
Time frame: Up to approximately 281 weeks.
CE Phase: Number of Participants With AEs Leading to Dose Reduction or Delay
Number of participants with dose reduction or delay were to be evaluated.
Time frame: Up to approximately 281 weeks.
CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters
Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant; Grade 4 (G4): Life-threatening consequences; Grade 5 (G5): Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
Time frame: Baseline (Day 1) and up to approximately 281 weeks.
CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters
Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. G1: mild; G2: moderate; G3: severe or medically significant; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
Time frame: Baseline (Day 1) and up to approximately 281 weeks.
This is a sub-study of the master study NCT04126200. The study was planned to include two phases - Dose Escalation (DE) and Cohort Expansion (CE) and no participants from this sub study were enrolled in CE phase as CE Phase was not initiated due to business strategic reason.
| Milestone | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| Started | 9 | 10 | 6 |
| Completed | 9 | 9 | 4 |
| Not completed | 0 | 1 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Ongoing at the time of analysis | 0 | 0 | 1 |
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLT severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLTs) | 1 | 1 | 0 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| DE Phase: Number of Participants With Adverse Events (AEs) | 9 | 9 | 6 |
Blood samples were collected for evaluation of hematology parameters including Anemia, Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| Anemia, Increase to G1 | 1 | 1 | 0 |
| Anemia, Increase to G2 | 0 | 1 | 0 |
| Anemia, Increase to G3 | 2 | 2 | 1 |
| Anemia, Increase to G4 | 0 | 0 | 0 |
| HbI, Increase to G1 | 0 | 1 | 0 |
| HbI, Increase to G2 | 0 | 0 | 0 |
| HbI, Increase to G3 | 0 | 0 | 0 |
| HbI, Increase to G4 | 0 | 0 | 0 |
| LyD, Increase to G1 | 1 | 2 | 1 |
| LyD, Increase to G2 | 1 | 1 | 2 |
| LyD, Increase to G3 | 2 | 4 | 1 |
| LyD, Increase to G4 | 1 | 0 | 0 |
| LyI, Increase to G1 | 0 | 0 | 0 |
| LyI, Increase to G2 | 1 | 1 | 0 |
| LyI, Increase to G3 | 0 | 0 | 0 |
| LyI, Increase to G4 | 0 | 0 | 0 |
| NeuD, Increase to G1 | 2 | 0 | 0 |
| NeuD, Increase to G2 | 2 | 3 | 1 |
| NeuD, Increase to G3 | 0 | 1 | 1 |
| NeuD, Increase to G4 | 1 | 0 | 0 |
| PD, Increase to G1 | 3 | 4 | 4 |
| PD, Increase to G2 | 1 | 1 | 0 |
| PD, Increase to G3 | 1 | 2 | 1 |
| PD, Increase to G4 | 2 | 2 | 0 |
| LC, Increase to G1 | 0 | 0 | 0 |
| LC, Increase to G2 | 1 | 0 | 0 |
| LC, Increase to G3 | 0 | 0 | 0 |
| LC, Increase to G4 | 0 | 0 | 0 |
| WBCD, Increase to G1 | 1 | 3 | 1 |
| WBCD, Increase to G2 | 2 | 2 | 2 |
| WBCD, Increase to G3 | 1 | 1 | 0 |
| WBCD, Increase to G4 | 1 | 0 | 0 |
Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia (HypoG), hypoalbuminemia (HypoA), creatine kinase increased (CPKI), hyperkalemia, blood lactate dehydrogenase increased (LDHI), hypermagnesemia (HyperM), hypomagnesemia (HypoM), hypernatremia (HyperN), hypercalcemia (HyperC), hypocalcemia (HypoC) and chronic kidney disease (CKD). ). The laboratory parameters were graded according to CTCAE v 5.0. G1: mild; G2: moderate; G3: severe; G4: life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented. The laboratory parameters were graded according to CTCAE v 5.0.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| HypoG, Increase to G1 | 2 | 2 | 0 |
| HypoG, Increase to G2 | 0 | 0 | 0 |
| HypoG, Increase to G3 | 0 | 0 | 0 |
| HypoG, Increase to G4 | 0 | 0 | 0 |
| HypoA, Increase to G1 | 3 | 2 | 1 |
| HypoA, Increase to G2 | 3 | 3 | 2 |
| HypoA, Increase to G3 | 0 | 1 | 0 |
| HypoA, Increase to G4 | 0 | 0 | 0 |
| CPKI, Increase to G1 | 0 | 4 | 2 |
| CPKI, Increase to G2 | 0 | 1 | 0 |
| CPKI, Increase to G3 | 0 | 0 | 1 |
| CPKI, Increase to G4 | 0 | 0 | 0 |
| Hyperkalemia, Increase to G1 | 0 | 0 | 2 |
| Hyperkalemia, Increase to G2 | 0 | 0 | 0 |
| Hyperkalemia, Increase to G3 | 0 | 0 | 0 |
| Hyperkalemia, Increase to G4 | 0 | 0 | 0 |
| LDHI, Increase to G1 | 3 | 4 | 2 |
| LDHI, Increase to G2 | 0 | 0 | 0 |
| LDHI, Increase to G3 | 0 | 0 | 0 |
| LDHI, Increase to G4 | 0 | 0 | 0 |
| HyperM, Increase to G1 | 0 | 0 | 1 |
| HyperM, Increase to G2 | 0 | 0 | 0 |
| HyperM, Increase to G3 | 1 | 0 | 0 |
| HyperM, Increase to G4 | 0 | 1 | 0 |
| HypoM, Increase to G1 | 2 | 3 | 2 |
| HypoM, Increase to G2 | 1 | 1 | 0 |
| HypoM, Increase to G3 | 0 | 0 | 0 |
| HypoM, Increase to G4 | 0 | 0 | 0 |
| HyperN, Increase to G1 | 0 | 2 | 0 |
| HyperN, Increase to G2 | 0 | 0 | 0 |
| HyperN, Increase to G3 | 0 | 0 | 0 |
| HyperN, Increase to G4 | 0 | 0 | 0 |
| HyperC, Increase to G1 | 3 | 1 | 1 |
| HyperC, Increase to G2 | 0 | 1 | 1 |
| HyperC, Increase to G3 | 0 | 2 | 0 |
| HyperC, Increase to G4 | 1 | 1 | 0 |
| HypoC, Increase to G1 | 2 | 0 | 3 |
| HypoC, Increase to G2 | 0 | 0 | 0 |
| HypoC, Increase to G3 | 0 | 0 | 0 |
| HypoC, Increase to G4 | 0 | 0 | 0 |
| CKD, Increase to G1 | 0 | 0 | 0 |
| CKD, Increase to G2 | 2 | 3 | 3 |
| CKD, Increase to G3 | 1 | 1 | 0 |
| CKD, Increase to G4 | 0 | 0 | 0 |
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
No measurements were reported for this outcome.
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
| Percentage of Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| DE Phase: Overall Response Rate (ORR) | 44 (13.7 to 78.8) | 50 (18.7 to 81.3) | 67 (22.3 to 95.7) |
Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
No measurements were reported for this outcome.
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
| Percentage of Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| Stringent Complete Response (sCR) | 0 | 10 | 0 |
| Complete Response (CR) | 11 | 0 | 17 |
| Very Good Partial Response (VGPR) | 22 | 40 | 33 |
| Partial Response (PR) | 11 | 0 | 17 |
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
No measurements were reported for this outcome.
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
| Nanogram/ millilitre (ng/mL) | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| C1 D1, PRE-DOSE | 0.0 ± 0.00 | 0.0 ± 0.00 | 0.0 ± 0.00 |
| C1 D1, END OF INFUSION | 30088.9 ± 7793.18 | 43460.0 ± 7254.76 | 48350.0 ± 15195.76 |
| C1 D1, 2 HOURS | 29933.3 ± 5308.95 | 41370.0 ± 10445.10 | 40600.0 ± 8739.34 |
| C1 D1, 24 HOURS | 19100.0 ± 4184.20 | 28350.0 ± 9022.35 | 33383.3 ± 10192.43 |
| C1 D4, ANYTIME SAMPLE | 10310.0 ± 4016.24 | 14512.0 ± 6392.34 | 22783.3 ± 7980.33 |
| C1 D8, ANYTIME SAMPLE | 5325.0 ± 1740.97 | 6828.0 ± 3273.79 | 13208.3 ± 7262.77 |
| C2 D1, PRE-DOSE | 1885.0 ± 755.32 | 1806.3 ± 859.18 | 3774.8 ± 2319.76 |
| C2 D1, END OF INFUSION | 31062.5 ± 3108.48 | 40525.0 ± 12523.32 | 39195.0 ± 20443.90 |
| C4 D1, PRE-DOSE | 2720.0 ± 1129.07 | 3395.0 ± 1578.05 | 4235.3 ± 3102.85 |
| C4 D1, END OF INFUSION | 32533.3 ± 6459.36 | 56550.0 ± 21043.21 | 46766.7 ± 12470.90 |
| C6 D1, PRE-DOSE | 2700.0 ± 452.55 | 2933.3 ± 2578.16 | 3983.3 ± 1228.59 |
| C6 D1, END OF INFUSION | 28400.0 ± 3818.38 | 48800.0 ± 8660.83 | 40366.7 ± 3550.12 |
| C9 D1, PRE-DOSE | 3895.0 ± 148.49 | 4453.3 ± 1170.70 | 3385.0 ± 1053.59 |
| C9 D1, END OF INFUSION | 28250.0 ± 5868.99 | 34166.7 ± 5832.10 | 47050.0 ± 16899.85 |
| C12 D1, PRE-DOSE | 1587.0 ± 1432.60 | 3580.0 ± 5062.88 | 2230.0 ± NA |
| C12 D1, END OF INFUSION | 25600.0 ± 8485.28 | 39600.0 ± 424.26 | 28200.0 ± NA |
| C18 D1, PRE-DOSE | 1450.0 ± NA | 6300.0 ± NA | — |
| EoT (up to ~ 281 weeks) | 3755.0 ± 2353.23 | 1779.8 ± 1830.77 | 4576.7 ± 4803.09 |
Blood samples were planned to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC).
No measurements were reported for this outcome.
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
| Nanogram/ millilitre (ng/mL) | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| C1 D1, PRE-DOSE | 0.0 ± 0.00 | 0.0 ± 0.00 | 0.0 ± 0.00 |
| C1 D1, END OF INFUSION | 31985.7 ± 9190.29 | 50220.0 ± 10478.63 | 47283.3 ± 9736.00 |
| C1 D1, 2 HOURS | 31333.3 ± 8256.97 | 48970.0 ± 11250.09 | 47300.0 ± 12637.25 |
| C1 D1, 24 HOURS | 23342.9 ± 5629.64 | 34950.0 ± 9689.77 | 37700.0 ± 10519.32 |
| C1 D4, ANYTIME SAMPLE | 16672.5 ± 6065.01 | 22250.0 ± 8853.78 | 26950.0 ± 6100.41 |
| C1 D8, ANYTIME SAMPLE | 12197.5 ± 4290.74 | 15358.0 ± 7106.24 | 18690.0 ± 8274.19 |
| C2 D1, PRE-DOSE | 5920.0 ± 2982.95 | 5921.3 ± 3611.93 | 10561.7 ± 5024.85 |
| C2 D1, END OF INFUSION | 39028.6 ± 10166.40 | 50425.0 ± 13992.93 | 60320.0 ± 19478.63 |
| C4 D1, PRE-DOSE | 13463.3 ± 6636.79 | 14532.5 ± 8186.51 | 18190.0 ± 14219.43 |
| C4 D1, END OF INFUSION | 75333.3 ± 37026.66 | 55975.0 ± 16597.46 | 68500.0 ± 21672.33 |
| C6 D1, PRE-DOSE | 14450.0 ± 2474.87 | 13576.7 ± 10349.14 | 15026.7 ± 4452.43 |
| C6 D1, END OF INFUSION | 45150.0 ± 6858.94 | 62666.7 ± 16740.77 | 62450.0 ± 15202.80 |
| C9 D1, PRE-DOSE | 14300.0 ± 141.42 | 23533.3 ± 14117.13 | 8980.0 ± 7099.35 |
| C9 D1, END OF INFUSION | 47250.0 ± 9828.78 | 62100.0 ± 16721.54 | 75700.0 ± 6929.65 |
| C12 D1, PRE-DOSE | 8165.0 ± 3726.45 | 15850.0 ± 20718.23 | 15000.0 ± NA |
| C12 D1, END OF INFUSION | 43250.0 ± 14354.27 | 54400.0 ± 25031.58 | 53800.0 ± NA |
| C18 D1, PRE-DOSE | 8180.0 ± NA | 34500.0 ± NA | — |
| EoT (up to ~ 281 weeks) | 11052.0 ± 6119.81 | 8862.0 ± 11401.80 | 15643.3 ± 15040.13 |
Blood samples were planned to be collected for PK analysis of Belantamab mafodotin plasma total antibody.
No measurements were reported for this outcome.
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
| Picogram / millilitre (pg/mL) | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| C1 D1, PRE-DOSE | 0.00 ± 0.000 | 0.00 ± 0.000 | 0.00 ± 0.000 |
| C1 D1, END OF INFUSION | 348.33 ± 174.415 | 362.90 ± 152.074 | 411.83 ± 239.787 |
| C1 D1, 2 HOURS | 397.67 ± 219.583 | 439.60 ± 151.680 | 575.33 ± 386.115 |
| C1 D1, 24 HOURS | 1126.11 ± 1529.405 | 1059.60 ± 861.657 | 917.67 ± 439.953 |
| C1 D4, ANYTIME SAMPLE | 313.38 ± 102.131 | 645.00 ± 434.713 | 628.50 ± 147.267 |
| C1 D8, ANYTIME SAMPLE | 116.49 ± 38.063 | 196.92 ± 57.691 | 247.50 ± 66.768 |
| C2 D1, PRE-DOSE | 0.00 ± 0.000 | 0.00 ± 0.000 | 0.00 ± 0.000 |
| C2 D1, END OF INFUSION | 295.14 ± 84.044 | 386.75 ± 212.491 | 368.67 ± 360.003 |
| C4 D1, PRE-DOSE | 0.00 ± 0.000 | 0.00 ± 0.000 | 0.00 ± 0.000 |
| C4 D1, END OF INFUSION | 513.67 ± 321.674 | 362.00 ± 136.936 | 367.67 ± 145.308 |
| C6 D1, PRE-DOSE | 0.00 ± 0.000 | 0.00 ± 0.000 | 0.00 ± 0.000 |
| C6 D1, END OF INFUSION | 435.00 ± 106.066 | 318.33 ± 40.857 | 504.67 ± 604.086 |
| C9 D1, PRE-DOSE | 0.00 ± 0.000 | 0.00 ± 0.000 | 0.00 ± 0.000 |
| C9 D1, END OF INFUSION | 207.50 ± 21.920 | 455.00 ± 310.066 | 392.00 ± 229.103 |
| C12 D1, PRE-DOSE | 0.00 ± 0.000 | 0.00 ± 0.000 | 0.00 ± NA |
| C12 D1, END OF INFUSION | 298.00 ± 15.556 | 194.50 ± 7.778 | 0.00 ± NA |
| C18 C1, PRE-DOSE | 0.00 ± NA | 0.00 ± NA | — |
| EoT (up to ~ 281 weeks) | 77.60 ± 116.055 | 0.00 ± 0.000 | 110.33 ± 191.103 |
Blood samples were planned to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
No measurements were reported for this outcome.
Blood samples were collected for PK analysis of Feladilimab when administered intravenously in combination with belantamab mafodotin.
| ng/mL | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| C1 D1, PRE-DOSE | 0.0 ± 0.00 | 0.0 ± 0.00 | 0.0 ± 0.00 |
| C1 D1, END OF INFUSION | 1705.3 ± 684.19 | 1938.3 ± 687.81 | 5797.5 ± 3013.48 |
| C1 D1, 24 HOURS | 1516.9 ± 604.62 | 1682.0 ± 513.07 | 5758.0 ± 2782.99 |
| C1 D1, 2-4 HOURS | 1914.4 ± 849.74 | 2018.5 ± 671.16 | 5850.6 ± 1393.26 |
| C1 D4, ANYTIME SAMPLE | 1091.1 ± 502.26 | 1236.8 ± 432.22 | 4739.2 ± 1544.46 |
| C1 D8, ANYTIME SAMPLE | 876.6 ± 438.91 | 981.4 ± 374.22 | 3694.7 ± 1623.62 |
| C2 D1, PRE-DOSE | 499.8 ± 303.58 | 471.3 ± 187.95 | 2378.0 ± 1084.60 |
| C2 D1, END OF INFUSION | 2407.1 ± 1005.90 | 2365.1 ± 1099.94 | 7489.0 ± 3799.51 |
| C4 D1, PRE-DOSE | 1046.7 ± 245.62 | 827.0 ± 281.32 | 2799.7 ± 1630.91 |
| C4 D1, END OF INFUSION | 1784.0 ± 1373.86 | 2777.5 ± 1130.40 | 4573.0 ± 4594.49 |
| C6 D1, PRE-DOSE | 1125.5 ± 324.56 | 798.0 ± 557.71 | 2995.0 ± 1194.20 |
| C6 D1, END OF INFUSION | 2148.5 ± 1075.51 | 2985.7 ± 794.72 | 7097.7 ± 2374.84 |
| C9 D1, PRE-DOSE | 750.0 ± 1060.66 | 643.7 ± 188.34 | 2963.0 ± 1158.24 |
| C9 D1, END OF INFUSION | 1405.0 ± NA | 2298.3 ± 559.96 | 7779.0 ± 2736.50 |
| C12 D1, PRE-DOSE | 791.0 ± 907.93 | 357.0 ± 504.87 | — |
| C12 D1, END OF INFUSION | 1901.0 ± 2479.12 | 1982.0 ± 192.33 | 7859.0 ± NA |
| C18 D1, PRE-DOSE | 877.0 ± NA | 774.0 ± NA | — |
| EoT (up to ~ 281 weeks) | 714.6 ± 435.71 | 540.2 ± 139.23 | 5330.0 ± 6407.23 |
Blood samples were planned to be collected for PK analysis Feladilimab when administered intravenously in combination with belantamab mafodotin.
No measurements were reported for this outcome.
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 | 1 | 0 |
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
No measurements were reported for this outcome.
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
| Titer | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| DE Phase: Titer of ADAs Against Belantamab Mafodotin | — | 100 (NA to NA) | — |
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
No measurements were reported for this outcome.
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| DE Phase: Number of Participants With Post-baseline Positive ADAs Against Feladilimab | 0 | 0 | 0 |
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
No measurements were reported for this outcome.
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
No measurements were reported for this outcome.
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
No measurements were reported for this outcome.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) | 8 | 9 | 6 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were planned to be collected.
No measurements were reported for this outcome.
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.
| Participants | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| G1 | 3 | 0 | 0 |
| G2 | 0 | 4 | 2 |
| G3 | 2 | 3 | 3 |
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.
No measurements were reported for this outcome.
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
No measurements were reported for this outcome.
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
No measurements were reported for this outcome.
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
No measurements were reported for this outcome.
OS is defined as the time from randomization until death due to any cause.
No measurements were reported for this outcome.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
No measurements were reported for this outcome.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to discontinuation were to be evaluated.
No measurements were reported for this outcome.
Number of participants with dose reduction or delay were to be evaluated.
No measurements were reported for this outcome.
Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant; Grade 4 (G4): Life-threatening consequences; Grade 5 (G5): Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
No measurements were reported for this outcome.
Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. G1: mild; G2: moderate; G3: severe or medically significant; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
No measurements were reported for this outcome.
Collected over All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 281 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 7/9 (77.8%) | 3/9 (33.3%) | 9/9 (100%) |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 6/10 (60%) | 6/10 (60%) | 9/10 (90%) |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 2/6 (33.3%) | 1/6 (16.7%) | 6/6 (100%) |
| Event | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 0/9 | 2/10 | 0/6 |
| HypercalcaemiaMetabolism and nutrition disorders | 0/9 | 2/10 | 0/6 |
| Rhinovirus infectionInfections and infestations | 0/9 | 0/10 | 1/6 |
| PneumoniaInfections and infestations | 1/9 | 1/10 | 0/6 |
| SepsisInfections and infestations | 1/9 | 0/10 | 0/6 |
| Infusion related reactionInjury, poisoning and procedural complications | 1/9 | 1/10 | 0/6 |
| Blood creatinine increasedInvestigations | 1/9 | 0/10 | 0/6 |
| Chest painGeneral disorders | 0/9 | 1/10 | 0/6 |
| PyrexiaGeneral disorders | 0/9 | 1/10 | 0/6 |
| Craniofacial fractureInjury, poisoning and procedural complications | 0/9 | 1/10 | 0/6 |
| Event | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab |
|---|---|---|---|
| KeratopathyEye disorders | 4/9 | 7/10 | 3/6 |
| Dry eyeEye disorders | 3/9 | 3/10 | 4/6 |
| PhotophobiaEye disorders | 2/9 | 3/10 | 4/6 |
| Vision blurredEye disorders | 4/9 | 6/10 | 4/6 |
| AnaemiaBlood and lymphatic system disorders | 4/9 | 6/10 | 2/6 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/9 | 5/10 | 2/6 |
| CataractEye disorders | 0/9 | 1/10 | 3/6 |
| Aspartate aminotransferase increasedInvestigations | 2/9 | 1/10 | 3/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/9 | 3/10 | 3/6 |
| Eye irritationEye disorders | 1/9 | 1/10 | 2/6 |
| Age, Continuous(YEARS) | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | Total |
|---|---|---|---|---|
| Mean | 65.7 ± 8.90 | 67.6 ± 7.71 | 62.2 ± 10.38 | 65.6 ± 8.70 |
| Sex: Female, Male(Participants) | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | Total |
|---|---|---|---|---|
| Female | 6 | 4 | 2 | 12 |
| Male | 3 | 6 | 4 | 13 |
| Race (NIH/OMB)(Participants) | 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 7 | 9 | 5 | 21 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Plan to share: No — GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.
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