A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)
Plasma cell neoplasm
18 Years and older, Male and Female
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.
The drug being tested in this study is called TAK-981. TAK-981 in combination with an
anti-CD38 monoclonal antibody (mAbs) is being tested to treat people who have RRMM. The study
will include a dose escalation phase and a dose expansion phase.
The study will enroll approximately 81 participants; approximately 30 participants in the
dose escalation phase (Part 1) approximately 15 participants in (Part 2) and up to 36
participants in dose expansion phase (Part 2). Participants will receive escalating doses of
TAK-981 in combination with fixed doses as follows:
- Phase 1b, Part 1 - Dose Escalation: Arm A - TAK-981 Twice Weekly (BIW) + Mezagitamab
- Phase 1b, Part 1 - Dose Escalation: Arm B - TAK-981 Weekly (QW) + Mezagitamab
- Phase 1b, Part 2 - Dose Escalation: TAK-981 + Daratumumab and Hyaluronidase-fihj
Once RP2D is determined in Phase 1, participants with RRMM will be enrolled in Phase 2.
• Phase 2 - Dose Expansion: TAK-981 + Daratumumab and Hyaluronidase-fihj or Mezagitamab
This multi-center trial will be conducted in North America. The overall time to participate
in this study is 2 years. Participants will make multiple visits to the clinic, and
progression-free survival follow-up for maximum up to 12 months after last dose of study
- Participants must have RRMM with measurable disease: a) Has measurable disease defined as one of the following:
- Serum M-protein =0.5 g/dL (=5 g/L).
- Urine M-protein =200 mg/24 hours.
- In participants without measurable M-protein in serum protein electrophoresis (SPEP) or urine protein electrophoresis (UPEP), a serum free light chain (FLC) assay result with involved FLC level =10 mg/dL (=100 mg/L), provided serum FLC ratio is abnormal.
- Has undergone stem cell transplant or is considered transplant ineligible.
- Has failed at least 3 prior lines of anti-myeloma treatments and is either refractory, or intolerant to at least 1 immunomodulatory drug ( IMiD); (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 proteasome inhibitor (ie, bortezomib, ixazomib or carfilzomib), and refractory to at least 1 anti-CD38 antibody and who have demonstrated disease progression with the last therapy.
Treatment Sites in Georgia
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