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A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2


Description

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.

Trial 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 Info

Organization

Bristol-Myers Squibb


Primary Outcome

Progression-free Survival (PFS)


Outcome Timeframe Up to approximately 5 years

NCTID NCT05552976

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2023-01-10

Completion Date 2026-02-04

Enrollment Target 525

Interventions

DRUG Mezigdomide

DRUG Carfilzomib

DRUG Dexamethasone

Locations Recruiting

USA Mitchell Cancer Institute

United States, Alabama, Mobile


TOI Clinical Research

United States, California, Cerritos


Kaiser Permanente - Irvine

United States, California, Irvine


Los Angeles Hematology Oncology Medical Group

United States, California, Los Angeles


Local Institution - 0344

United States, California, Santa Rosa


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