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A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)

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Titre complet:
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
Description détaillée:
Non disponible
Traitements:
Drug : Alnuctamab

Specified dose on specified days

Drug : Pomalidomide

Specified dose on specified days

Drug : Daratumumab

Specified dose on specified days

Drug : Elotuzumab

Specified dose on specified days

Drug : Carfilzomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Groupes d'étude:
Experimental : Arm A: Alnuctamab
Active Comparator : Arm B: Standard of Care Regimens
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
À venir
Critères d'admissibilités:
sion Criteria
  • Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
  • Documented diagnosis of multiple myeloma (MM), and must:. i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy. ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles). iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy. iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.
  • Must have measurable disease (as determined by central laboratory).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening. Exclusion Criteria
  • Active, uncontrolled, or suspected infection.
  • Known current, or history of, central nervous system involvement of multiple myeloma.
  • History or presence of clinically relevant CNS pathology.
  • Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
  • Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
    • Lieux / Centres:

    Local Institution - 0417, Calgary, Alberta – ()

    Local Institution - 0423, Edmonton, Alberta – ()

    Local Institution - 0402, London, Ontario – ()

    Local Institution - 0395, Toronto, Ontario – ()

    Local Institution - 0031, Montreal, Quebec – ()

    Local Institution - 0098, Montréal, Quebec – ()

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    Date d’affichage:
    2024-01-31
    Date de début:
    March 29, 2024
    Dernière mise à jour:
    2024-03-27
    Nombre d'inscriptions anticipées:
    466
    Date de fin prévue:
    2030-09-21
    Date de fin prévue de l'étude primaire:
    2025-11-16
    Condition:
    Multiple Myeloma
    Genre:
    All
    Âge:
    18 Years-N/A
    Accepte des bénévoles en santé:
    No
    Pays participants:
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Czechia
    France
    Germany
    Greece
    Hungary
    India
    Ireland
    Italy
    Japan
    Korea, Republic of
    Norway
    Portugal
    Romania
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    Numéro d’identification:
    NCT06232707
    Autres numéros d'identification de l'étude:
    CA058-1019
    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
    Celgene
    Industry
    Collaborators:
    ???
    Chercheurs:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Date de vérification:
    2024-03-01