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A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)

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Titre complet:
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
Description détaillée:
Non disponible
Traitements:
Biological : idecabtagene vicleucel

Specified dose on specified days

Drug : Lenalidomide

Specified dose on specified days

Drug : Fludarabine

Specified dose on specified days

Drug : Cyclophosphamide

Specified dose on specified days

Groupes d'étude:
Experimental : Arm A
Active Comparator : Arm B
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
sion Criteria
  • Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
  • Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
  • Participant must have documented response of PR or VGPR at time of consent.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
  • Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria
  • Participant with known central nervous system involvement with myeloma.
  • Participant has non-secretory MM.
  • Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
  • Participant has history of primary immunodeficiency.
  • Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
    • Lieux / Centres:

    Local Institution - 0133, Edmonton, Alberta – À venir

    Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario – En cours

    Local Institution - 0134, Montreal, Quebec – À venir

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    Date d’affichage:
    2023-09-21
    Date de début:
    October 16, 2023
    Dernière mise à jour:
    2024-05-09
    Nombre d'inscriptions anticipées:
    618
    Date de fin prévue:
    2032-07-04
    Date de fin prévue de l'étude primaire:
    2031-03-27
    Condition:
    Multiple Myeloma
    Genre:
    All
    Âge:
    18 Years-N/A
    Accepte des bénévoles en santé:
    No
    Pays participants:
    Australia
    Austria
    Belgium
    Canada
    Czechia
    Denmark
    France
    Germany
    Greece
    Israel
    Italy
    Japan
    Korea, Republic of
    Norway
    Poland
    Romania
    Spain
    United Kingdom
    United States
    Numéro d’identification:
    NCT06045806
    Autres numéros d'identification de l'étude:
    CA089-1043
    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:
    collaborator
    Bristol-Myers Squibb
    Industry
    lead_sponsor
    Celgene
    Industry
    Collaborators:
    ???
    Chercheurs:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Date de vérification:
    2024-05-01