NCT05556616

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of Intravenous Modakafusp Alfa as Part of Combination Therapy in Adult Patients With Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide * Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide * Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib * Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib * Group 3 RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib * Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Modakafusp alfa	Modakafusp alfa intravenous infusion.
DRUG	Lenalidomide	Lenalidomide capsules orally.
DRUG	Bortezomib	Bortezomib injection subcutaneously.
DRUG	Carfilzomib	Carfilzomib intravenous infusion.
DRUG	Daratumumab	Daratumumab injection subcutaneously.
DRUG	Pomalidomide	Pomalidomide capsules orally.

Timeline

• Start date: 2023-01-12
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2022-09-27
• Last updated: 2026-01-29
• Results posted: 2025-08-06

Locations

21 sites across 4 countries: United States, Belgium, Israel, Spain

Regulatory

• FDA-regulated drug study