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)

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Full Title:
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
Myeloma stage or condition:
Relapsed or Refractory Multiple Myeloma
Study phase:
Phase 3
Summary/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.
Detailed Description:
Not available
Treatments:
Drug : Mezigdomide

Specified dose on specified days

Drug : Carfilzomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Study Arms:
Experimental : MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
Active Comparator : Kd (Carfilzomib + Dexamethasone)
Study Type:
Interventional
Study Design:
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.
Recruitment status:
Recruiting
Eligibility criteria:
sion 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.
  • Locations / Centres:

    QEII Health Sciences Centre - Victoria General Site, Halifax, Nova Scotia – Recruiting

    Victoria Hospital & Children's Hospital - London Health Sciences Centre, London, Ontario – Recruiting

    Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting

    Local Institution - 0186, Montreal, Quebec – Withdrawn

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    First posted:
    2022-09-23
    Actual start date:
    January 10, 2023
    Last updated:
    2024-04-10
    Estimated enrollment:
    525
    Estimated completion date:
    2029-07-25
    Estimated primary completion date:
    2026-02-04
    Condition:
    Relapsed or Refractory Multiple Myeloma
    Gender:
    All
    Ages:
    18 Years-N/A
    Accepts healthy volunteers:
    No
    Listed location countries:
    Argentina
    Australia
    Austria
    Brazil
    Bulgaria
    Canada
    China
    Colombia
    Denmark
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Puerto Rico
    Romania
    Singapore
    Spain
    Taiwan
    United Kingdom
    United States
    NCT number:
    NCT05552976
    Other study ID numbers:
    CA057-008
    Has Data monitoring committee:
    Yes
    U.S. FDA-regulated product:
    Yes
    IPD Sharing Statement :
    ???
    Responsible party:
    Sponsor
    Study sponsor:
    lead_sponsor
    Bristol-Myers Squibb
    Industry
    Collaborators:
    ???
    Investigators:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Verification date:
    2024-04-01