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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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Titre complet:
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
Stade ou Condition:
Relapsed or Refractory Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
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.
Description détaillée:
Non disponible
Traitements:
Drug : Mezigdomide

Specified dose on specified days

Drug : Carfilzomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Groupes d'étude:
Experimental : MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
Active Comparator : Kd (Carfilzomib + Dexamethasone)
Type d'étude:
Interventional
Protocole de l'étude:
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.
Statut du recrutement:
En cours
Critères d'admissibilités:
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.
    • Lieux / Centres:

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

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

    Princess Margaret Cancer Centre, Toronto, Ontario – En cours

    Local Institution - 0186, Montreal, Quebec – Retiré

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    Date d’affichage:
    2022-09-23
    Date de début:
    January 10, 2023
    Dernière mise à jour:
    2024-05-01
    Nombre d'inscriptions anticipées:
    525
    Date de fin prévue:
    2029-07-25
    Date de fin prévue de l'étude primaire:
    2026-02-04
    Condition:
    Relapsed or Refractory Multiple Myeloma
    Genre:
    All
    Âge:
    18 Years-N/A
    Accepte des bénévoles en santé:
    No
    Pays participants:
    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
    Numéro d’identification:
    NCT05552976
    Autres numéros d'identification de l'étude:
    CA057-008
    Comité de suivi des données:
    Yes
    Produit réglementé par la FDA (É-U):
    Yes
    IPD Sharing Statement :
    ???
    Responsables de l’étude:
    Sponsor
    Commanditaires de l’étude:
    lead_sponsor
    Bristol-Myers Squibb
    Industry
    Collaborators:
    ???
    Chercheurs:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Date de vérification:
    2024-05-01