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)

Purpose

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.

Condition

  • Relapsed or Refractory Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a two-stage inferentially seamless design.
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
This is an open-label study; however, any review of aggregate study data by the Sponsor will be performed in a blinded manner.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
  • Drug: Mezigdomide
    Specified dose on specified days
    Other names:
    • BMS-986348
    • CC-92480
  • Drug: Carfilzomib
    Specified dose on specified days
    Other names:
    • Kyprolis
  • Drug: Dexamethasone
    Specified dose on specified days
    Other names:
    • Decadron
    • Dex
Active Comparator
Kd (Carfilzomib + Dexamethasone)
  • Drug: Carfilzomib
    Specified dose on specified days
    Other names:
    • Kyprolis
  • Drug: Dexamethasone
    Specified dose on specified days
    Other names:
    • Decadron
    • Dex

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com