A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT04776018 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2024-10-02
Summary
TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies (mAbs) to treat participants who have relapsed or refractory multiple myeloma (RRMM).
The main aims of the study are to evaluate the safety and efficacy of TAK-981 in combination with anti-CD38 (mAbs) and to determine the recommended Phase 2 dose (RP2D).
Participants will be on this combination treatment for 28-day cycles. They will continue with this treatment until disease progression or unacceptable toxicity.
Conditions
- Relapsed and/or Refractory Multiple Myeloma (RRMM)
Interventions
- DRUG
-
TAK-981
TAK-981 IV infusion.
- DRUG
-
Mezagitamab
Mezagitamab SC injection.
- DRUG
-
Daratumumab and Hyaluronidase-fihj
Daratumumab and Hyaluronidase-fihj SC injection.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-20
- Primary Completion
- 2023-08-02
- Completion
- 2023-11-09
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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