Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.