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A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

Recruiting
18 years of age
Both
Phase 3

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Overview

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Eligibility

Inclusion Criteria

  • Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.
        ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein
        electrophoresis (uPEP) or,.
        iii) For participants without measurable disease in sPEP or uPEP: serum free light chain
        levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light
        chain ratio.
          -  Participant has received at least one prior line of anti-myeloma therapy. Note: One
             line can contain several phases (e.g., induction, [with or without] hematopoietic stem
             cell transplant, (with or without) consolidation, and/or [with or without] maintenance
             therapy).
          -  Participant must have received prior treatment with lenalidomide and at least 2 cycles
             of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an
             anti-CD38 mAb and received < 2 cycles are still eligible).
          -  Participant achieved minimal response or better to at least 1 prior anti-myeloma
             therapy.
          -  Participant must have documented disease progression during or after their last
             antimyeloma regimen.
        Exclusion Criteria
          -  Participant who has had prior treatment with mezigdomide or carfilzomib.
          -  Participant has previously received allogeneic stem cell transplant at any time or
             received autologous stem cell transplant within 12 weeks of initiating study
             treatment.
          -  Other protocol-defined Inclusion/Exclusion criteria apply.

Study details

Relapsed or Refractory Multiple Myeloma

NCT05552976

Bristol-Myers Squibb

26 June 2024

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