18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose-limiting Toxicities (DLTs)Primary· 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.
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)Primary· 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
Overall Response Rate (ORR)Secondary· 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. D
Groups 2 and 3: Disease Control Rate (DCR)Secondary· 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.
Time frame: Up to 16.7 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03215030 — A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
· Phase 1, PHASE2
· terminated
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
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· recruiting
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· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· recruiting
Other Teva Branded Pharmaceutical Products R&D LLC trials
Trials by the same sponsor.
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· recruiting
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· active not recruiting
NCT06911567 — A Study to Assess New Formulations of TEV-56286
· Phase 1
· completed
NCT06625177 — A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo
· Phase 1
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NCT06568237 — A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC
Last refreshed: 29 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05556616.