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)

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: Mezigdomide; Drug: Dexamethasone; Drug: Carfilzomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552976

CA057-008

Details and patient eligibility

About

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.

Enrollment: 525 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 2 patient groups

MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)

Experimental group

Treatment:

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Mezigdomide

Kd (Carfilzomib + Dexamethasone)

Active Comparator group

Treatment:

Drug: Carfilzomib

Drug: Dexamethasone