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.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)Primary· Phase 1: Cycle 1 (cycle length=28 days)
DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.
Phase 1: Number of Participants Reporting One or More TEAEs and Per SeverityPrimary· Phase 1: Up to 15.9 months
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTC
Phase 1: Overall Response Rate (ORR)Secondary· Phase 1: Up to 15.9 months
ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.
Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)Secondary· Up to 15.9 months
After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons and hence no participants were enrolled for Phase 2a.
Time frame: Phase 1: Up to 15.9 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04157517 — A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastat
· Phase 1, PHASE2
· terminated
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· 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.
NCT07197866 — An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
· Phase 2
· recruiting
NCT06807463 — A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
· Phase 2
· 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
· active not recruiting
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: 30 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/NCT05590377.