A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)

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Full Title:
A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1
Myeloma stage or condition:
Relapsed or Refractory Multiple Myeloma
Study phase:
Phase 3
Summary/Purpose:
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Detailed Description:
Not available
Treatments:
Drug : mezigdomide

Specified dose on specified days

Drug : Pomalidomide

Specified dose on specified days

Drug : Bortezomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Study Arms:
Experimental : MeziVd (mezigdomide, bortezomib and dexamethasone)
Experimental : PVd (pomalidomide, bortezomib and dexamethasone)
Study Type:
Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Recruitment status:
Recruiting
Eligibility criteria:
sion Criteria
  • Participant has documented diagnosis of MM and measurable disease, defined as any of the following:. i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or. ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP). iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
  • Participants received 1 to 3 prior lines of antimyeloma therapy.
  • Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy. Exclusion Criteria
  • Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:. i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.
  • For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
  • Participant has had prior treatment with mezigdomide or pomalidomide.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
  • Locations / Centres:

    Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Greenfield Park, Quebec – Recruiting

    Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur, Montreal, Quebec – Recruiting

    Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus, Quebec City, Quebec – Recruiting

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    First posted:
    2022-08-29
    Actual start date:
    September 20, 2022
    Last updated:
    2024-04-15
    Estimated enrollment:
    810
    Estimated completion date:
    2033-11-30
    Estimated primary completion date:
    2025-11-03
    Condition:
    Relapsed or Refractory Multiple Myeloma
    Gender:
    All
    Ages:
    18 Years-N/A
    Accepts healthy volunteers:
    No
    Listed location countries:
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Czechia
    Finland
    France
    Germany
    Greece
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Poland
    Portugal
    Puerto Rico
    Romania
    Spain
    Turkey
    United Kingdom
    United States
    NCT number:
    NCT05519085
    Other study ID numbers:
    CA057-001
    Has Data monitoring committee:
    Yes
    U.S. FDA-regulated product:
    Yes
    IPD Sharing Statement :
    ???
    Responsible party:
    Sponsor
    Study sponsor:
    lead_sponsor
    Celgene
    Industry
    Collaborators:
    ???
    Investigators:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Verification date:
    2024-04-01