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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Full Title:
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)
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 3
Summary/Purpose:
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).
Detailed Description:
Not available
Treatments:
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

Study Arms:
Experimental : Arm A
Active Comparator : Arm B
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
  • 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.
  • Locations / Centres:

    Local Institution - 0133, Edmonton, Alberta – Not yet recruiting

    Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario – Recruiting

    Local Institution - 0134, Montreal, Quebec – Not yet recruiting

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    First posted:
    2023-09-21
    Actual start date:
    October 16, 2023
    Last updated:
    2024-04-09
    Estimated enrollment:
    618
    Estimated completion date:
    2032-07-04
    Estimated primary completion date:
    2031-03-27
    Condition:
    Multiple Myeloma
    Gender:
    All
    Ages:
    18 Years-N/A
    Accepts healthy volunteers:
    No
    Listed location countries:
    Australia
    Austria
    Belgium
    Canada
    Czechia
    Denmark
    France
    Germany
    Greece
    Israel
    Italy
    Japan
    Korea, Republic of
    Norway
    Poland
    Romania
    Spain
    United Kingdom
    United States
    NCT number:
    NCT06045806
    Other study ID numbers:
    CA089-1043
    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