A Phase 1 interventional study of Modakafusp alfa and Lenalidomide in Multiple Myeloma, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Terminated at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC · Phase 1, Interventional, and Treatment
The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Participants will be given modakafusp alfa through a vein.
The drug being tested in this study is called modakafusp alfa (TAK-573). The study will evaluate the safety, tolerability and determine the recommended dose of modakafusp alfa in combination with lenalidomide in participants with multiple myeloma (MM), or in combination with pomalidomide, bortezomib, carfilzomib, or daratumumab in participants with relapsed/refractory multiple myeloma (RRMM).
The study consists of 3 Groups: Group 1: MM Maintenance Therapy, Group 2: RRMM Doublets, Group 3: RRMM Triplets.
The study will enroll approximately 18 participants in Group 1, 66 in Group 2, and 36 in Group 3. Participants will be assigned to one of the following treatment groups as given below:
Group 2 Arm 4 is closed for enrollment.
The study will be conducted worldwide. The maximum treatment duration in this study for Group 1 is until disease progression or unacceptable toxicity, or up to 2 years for minimal/measurable residual disease (MRD) negative [-] participants, whichever occurs first. The maximum treatment duration in this study for Group 2 and Group 3 is until disease progression, unacceptable toxicity or until any other discontinuation criterion is met, whichever occurs first. Overall time to participate in the study is approximately up to 5 years.
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This study's enrollment of 15 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
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Group 1 (MM maintenance: modakafusp alfa/lenalidomide) only must have:
Groups 2 and 3 (RRMM doublets and RRMM triplets) must have:
Measurable disease, defined as at least 1 of the following:
d. For Group 3 RRMM triplet arms only: Participants who have received 1 to 3 prior lines of antimyeloma therapy including at least 1 PI and, 1 IMiD, and who are not refractory to the combination partners.
e) For anti-CD38 arms, forced expiratory volume in 1second (FEV1) >=50% predicted by pulmonary function testing.
Exclusion criteria:
Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
Drug: Modakafusp alfa · Drug: Lenalidomide
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
Drug: Modakafusp alfa · Drug: Pomalidomide
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
Drug: Modakafusp alfa · Drug: Carfilzomib
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
Drug: Modakafusp alfa · Drug: Bortezomib
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Drug: Modakafusp alfa · Drug: Bortezomib · Drug: Pomalidomide
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Drug: Modakafusp alfa · Drug: Bortezomib · Drug: Pomalidomide
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Drug: Modakafusp alfa · Drug: Daratumumab · Drug: Pomalidomide
Modakafusp alfa intravenous infusion.
Also known as: TAK-573
Lenalidomide capsules orally.
Bortezomib injection subcutaneously.
Carfilzomib intravenous infusion.
Daratumumab injection subcutaneously.
Pomalidomide capsules orally.
Number of Participants With Dose-limiting Toxicities (DLTs)
DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions.
Time frame: Cycle 1 (Cycle length is 28 days)
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Time frame: Up to 16.7 months
Progression Free Survival (PFS)
PFS was defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD was determined by International Myeloma Working Group (IMWG) criteria. PD: increase of ≥25 percent (%) from lowest response value in any one or more of the following: serum M-component increase ≥0.5 gram per deciliter (g/dL) or urine M-component increase ≥200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (\>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell ≥10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 16.7 months
Overall Response Rate (ORR)
ORR: percentage of participants achieving confirmed partial response rate(PR)or better(stringent complete response\[sCR\]+complete response\[CR\]+very good partial response\[VGPR\]+PR)during study as defined by IMWG uniform response criteria and as determined by investigator.PR:\>=50%reduction of serum M-protein and\>=90% reduction in urine M-protein or less than(\<)200mg/24 hour, or\>=50%decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline,a \>=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to nearest single decimal place. Due to early termination of study no participants were enrolled in Group 2 Arm 4: modakafusp alfa+bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled criteria for Response-Evaluable Analysis Set, hence are not presented here. Given limited number of participants and low confidence interval as a consequence, those response rate provides limited information.
Time frame: Up to 16.7 months
Duration of Response (DOR)
DOR was defined as the time from the date of first documentation of confirmed PR or better (sCR+ CR+ VGPR+ PR) to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 16.7 months
Groups 2 and 3: Overall Survival (OS)
OS was defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.
Time frame: Up to 16.7 months
Groups 2 and 3: Time to Progression (TTP)
TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 16.7 months
Groups 2 and 3: Time to Next Treatment (TTNT)
TTNT was defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.
Time frame: Up to 16.7 months
Groups 2 and 3: Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place.
Time frame: Up to 16.7 months
Groups 2 and 3: Event-free Survival (EFS)
EFS was defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD was determined by IMWG criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 16.7 months
Groups 2 and 3: Time to Response (TTR)
TTR was defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria.
Time frame: Up to 16.7 months
Group 1: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5
Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who achieved MRD negative status in the MRD-evaluable analysis set.
Time frame: At 6 months, 1 year, and 2 years after the start of treatment
Groups 2 and 3: Percentage of Participants With MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator
Rate of MRD negativity CR status a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required.
Time frame: Up to 2 years after CR confirmation
Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 2 years after treatment
Group 2 and 3: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5
Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative status.
Time frame: Up to 16.7 months
Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity
Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 16.7 months
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb)
Time frame: Up to 16.7 months
Participants took part in the study at various investigative sites globally from 12 January 2023 to 04 June 2024.
| Milestone | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | Group 2 (RRMM Doublets) Arm 4: Modakafusp Alfa + Bortezomib | Group 3 (RRMM Triplets): Modakafusp Alfa + Pomalidomide + Bortezomib | Group 3 (RRMM Triplets): Modakafusp Alfa + Daratumumab + Pomalidomide |
|---|---|---|---|---|---|---|---|
| Started | 3 | 4 | 4 | 3 | 0 | 0 | 0 |
| Completed | 2 | 1 | 2 | 2 | 0 | 0 | 0 |
| Not completed | 1 | 3 | 2 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 2 | 1 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions.
| Participants | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 |
|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | 0 | 1 | 1 | 2 |
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
| Participants | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 |
|---|---|---|---|---|
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | 3 | 3 | 4 | 3 |
PFS was defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD was determined by International Myeloma Working Group (IMWG) criteria. PD: increase of ≥25 percent (%) from lowest response value in any one or more of the following: serum M-component increase ≥0.5 gram per deciliter (g/dL) or urine M-component increase ≥200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (\>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell ≥10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Results for this outcome have not been posted.
ORR: percentage of participants achieving confirmed partial response rate(PR)or better(stringent complete response\[sCR\]+complete response\[CR\]+very good partial response\[VGPR\]+PR)during study as defined by IMWG uniform response criteria and as determined by investigator.PR:\>=50%reduction of serum M-protein and\>=90% reduction in urine M-protein or less than(\<)200mg/24 hour, or\>=50%decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline,a \>=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to nearest single decimal place. Due to early termination of study no participants were enrolled in Group 2 Arm 4: modakafusp alfa+bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled criteria for Response-Evaluable Analysis Set, hence are not presented here. Given limited number of participants and low confidence interval as a consequence, those response rate provides limited information.
| percentage of participants | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 |
|---|---|---|---|
| Overall Response Rate (ORR) | 0 (0.00 to 60.24) | 50 (6.76 to 93.24) | 33.3 (0.84 to 90.57) |
DOR was defined as the time from the date of first documentation of confirmed PR or better (sCR+ CR+ VGPR+ PR) to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Results for this outcome have not been posted.
OS was defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.
Results for this outcome have not been posted.
TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Results for this outcome have not been posted.
TTNT was defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.
Results for this outcome have not been posted.
DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place.
| percentage of participants | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 |
|---|---|---|---|
| Groups 2 and 3: Disease Control Rate (DCR) | 75.0 (19.41 to 99.37) | 50.0 (6.76 to 93.24) | 66.7 (9.43 to 99.16) |
EFS was defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD was determined by IMWG criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Results for this outcome have not been posted.
TTR was defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria.
Results for this outcome have not been posted.
Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who achieved MRD negative status in the MRD-evaluable analysis set.
No measurements were reported for this outcome.
Rate of MRD negativity CR status a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required.
No measurements were reported for this outcome.
Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
No measurements were reported for this outcome.
Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative status.
No measurements were reported for this outcome.
Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
No measurements were reported for this outcome.
Results for this outcome have not been posted.
Collected over Up to 16.7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 0/4 (0%) | 1/4 (25%) | 3/4 (75%) |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 2/4 (50%) | 1/4 (25%) | 4/4 (100%) |
| Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 1/3 (33.3%) | 3/3 (100%) | 3/3 (100%) |
| Event | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 |
|---|---|---|---|---|
| Thrombotic microangiopathyBlood and lymphatic system disorders | 0/3 | 0/4 | 0/4 | 2/3 |
| Acute myocardial infarctionCardiac disorders | 0/3 | 0/4 | 0/4 | 1/3 |
| Haemolytic uraemic syndromeBlood and lymphatic system disorders | 0/3 | 0/4 | 0/4 | 1/3 |
| PalpitationsCardiac disorders | 0/3 | 0/4 | 0/4 | 1/3 |
| Pneumonia influenzalInfections and infestations | 0/3 | 0/4 | 0/4 | 1/3 |
| Renal failureRenal and urinary disorders | 0/3 | 0/4 | 0/4 | 1/3 |
| Renal haemorrhageRenal and urinary disorders | 0/3 | 0/4 | 0/4 | 1/3 |
| Deep vein thrombosisVascular disorders | 0/3 | 0/4 | 1/4 | 0/3 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/3 | 1/4 | 0/4 | 0/3 |
| Event | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/3 | 2/4 | 3/4 | 3/3 |
| NeutropeniaBlood and lymphatic system disorders | 3/3 | 3/4 | 3/4 | 0/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/3 | 3/4 | 3/4 | 3/3 |
| Alanine aminotransferase increasedInvestigations | 0/3 | 0/4 | 1/4 | 2/3 |
| Aspartate aminotransferase increasedInvestigations | 0/3 | 0/4 | 1/4 | 2/3 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/3 | 0/4 | 0/4 | 2/3 |
| HyponatraemiaMetabolism and nutrition disorders | 0/3 | 0/4 | 1/4 | 2/3 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/3 | 0/4 | 0/4 | 2/3 |
| InsomniaPsychiatric disorders | 0/3 | 1/4 | 0/4 | 2/3 |
| LeukopeniaBlood and lymphatic system disorders | 2/3 | 0/4 | 0/4 | 0/3 |
The Safety Analysis Set (SAS) included all participants who had received at least 1 dose, even if incomplete, of any study drug. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here.
| Age, Continuous(years) | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | Total |
|---|---|---|---|---|---|
| Mean | 62.3 ± 18.50 | 64.3 ± 11.00 | 71.3 ± 2.63 | 57.3 ± 12.06 | 64.4 ± 11.47 |
| Sex: Female, Male(Participants) | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | Total |
|---|---|---|---|---|---|
| Female | 2 | 0 | 2 | 0 | 4 |
| Male | 1 | 4 | 2 | 3 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 2 | 4 | 3 | 11 |
| Unknown or Not Reported | 1 | 2 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 | 1 | 5 |
| White | 2 | 1 | 2 | 2 | 7 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 0 | 0 | 2 |
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Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.
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