Trial · NCT05556616
A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma
NCT05556616, Phase 1, Terminated, Teva Branded Pharmaceutical Products R&D LLC; results first posted 2025-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma. Trials, record NCT05556616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05556616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma
- NCT number
- NCT05556616
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Conditions
- Multiple Myeloma
- Interventions
- Modakafusp alfa, Lenalidomide, Bortezomib, Carfilzomib, Daratumumab, Pomalidomide
- First posted
- 2022-09-27
- Last updated
- 2026-01-29
- Other registries' IDs
- eudract:2022-001418-20
- Results first posted
- 2025-08-06
- Limitations and caveats
Study was terminated early by sponsor for strategic reasons. No participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib \& Group 3 arms. Data for endpoints related to PFS, OS, DOR, TTP, TTNT, EFS, TTR, \& MRD were not collected as planned \& hence not reported.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | Cycle 1 (Cycle length is 28 days) | 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. |
| Primary | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Up to 16.7 months | 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. |
| Secondary | Progression Free Survival (PFS) | Up to 16.7 months | 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. |
| Secondary | Overall Response Rate (ORR) | Up to 16.7 months | 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. |
| Secondary | Duration of Response (DOR) | Up to 16.7 months | 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. |
| Secondary | Groups 2 and 3: Overall Survival (OS) | Up to 16.7 months | 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. |
| Secondary | Groups 2 and 3: Time to Progression (TTP) | Up to 16.7 months | 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. |
| Secondary | Groups 2 and 3: Time to Next Treatment (TTNT) | Up to 16.7 months | 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. |
| Secondary | Groups 2 and 3: Disease Control Rate (DCR) | Up to 16.7 months | 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. |
| Secondary | Groups 2 and 3: Event-free Survival (EFS) | Up to 16.7 months | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) | Cycle 1 (Cycle length is 28 days) | The DLT-evaluable Analysis Set included participants who experienced a DLT in Cycle 1 in the treatment phase of the study or completed Cycle 1 procedures and received a full Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of the combination partner. 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Up to 16.7 months | The 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to 16.7 months | |||
| SECONDARY | Overall Response Rate (ORR) | Up to 16.7 months | Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline \& at least 1 post-baseline efficacy evaluation. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Overall Survival (OS) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Time to Progression (TTP) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Time to Next Treatment (TTNT) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Disease Control Rate (DCR) | Up to 16.7 months | The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. 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. Also, no participants in Group 1 fulfilled the criteria for the Response-Evaluable Analysis Set and hence are not presented here. | percentage of participants | NUMBER |
| SECONDARY | Groups 2 and 3: Event-free Survival (EFS) | Up to 16.7 months |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 1 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 1 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 2 | Participants | ||
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 3 | Participants | ||
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 3 | Participants | ||
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 4 | Participants | ||
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 3 | Participants | ||
| Overall Response Rate (ORR) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 0 | 95% Confidence Interval 0.00 to 60.24 | percentage of participants | |
| Overall Response Rate (ORR) | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 50 | 95% Confidence Interval 6.76 to 93.24 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 3 | |
| Overall Study | STARTED | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 4 | |
| Overall Study | STARTED | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 4 | |
| Overall Study | STARTED | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 3 | |
| Overall Study | STARTED | Group 2 (RRMM Doublets) Arm 4: Modakafusp Alfa + Bortezomib | 0 | |
| Overall Study | STARTED | Group 3 (RRMM Triplets): Modakafusp Alfa + Pomalidomide + Bortezomib | 0 | |
| Overall Study | STARTED | Group 3 (RRMM Triplets): Modakafusp Alfa + Daratumumab + Pomalidomide | 0 | |
| Overall Study | COMPLETED | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 2 | |
| Overall Study | COMPLETED | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 1 | |
| Overall Study | COMPLETED | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 2 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events340
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 0 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 1 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 0 | 3 | |
| other | Acute kidney injury | Renal and urinary disorders | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0 | 3 | |
| other | Acute kidney injury | Renal and urinary disorders | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 0 | 4 | |
| other | Acute kidney injury | Renal and urinary disorders | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 0 | 4 | |
| other | Acute kidney injury | Renal and urinary disorders | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 1 | 3 | |
| other | Alanine aminotransferase increased | Investigations | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0 | 3 | |
| other | Alanine aminotransferase increased | Investigations | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 0 | 4 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0 | 3 |
| Total, all-cause mortality | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 0 | 4 |
| Total, all-cause mortality | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 2 | 4 |
| Total, all-cause mortality | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 1 | 3 |
| Total, other adverse events | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 3 | 3 |
| Total, other adverse events | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 3 | 4 |
| Total, other adverse events | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg | 4 | 4 |
| Total, other adverse events | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2 | 3 | 3 |
| Total, serious adverse events | Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg | 0 | 3 |
| Total, serious adverse events | Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg | 1 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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