A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

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Full Title:
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 3
Summary/Purpose:
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
Detailed Description:
Not available
Treatments:
Drug : Iberdomide

Specified dose on specified days

Drug : Lenalidomide

Specified dose on specified days

Study Arms:
Experimental : Arm A1: Iberdomide Dose 1
Experimental : Arm A2: Iberdomide Dose 2
Experimental : Arm A3: Iberdomide Dose 3
Active Comparator : Arm B: Lenalidomide
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
  • Confirmed diagnosis of symptomatic multiple myeloma (MM).
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
  • Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
  • Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria. Exclusion Criteria
  • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
  • Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
  • Known central nervous system/meningeal involvement of MM.
  • Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
  • Locations / Centres:

    Cross Cancer Institute, Edmonton, Alberta – Recruiting

    The Ottawa Hospital - General Campus, Ottawa, Ontario – Recruiting

    Local Institution - 0307, Montreal, Quebec – Not yet recruiting

    CHUQ - The Hôtel-Dieu de Québec, Quebec, – Recruiting

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    First posted:
    2023-04-24
    Actual start date:
    June 22, 2023
    Last updated:
    2024-04-09
    Estimated enrollment:
    1216
    Estimated completion date:
    2036-01-01
    Estimated primary completion date:
    2029-03-15
    Condition:
    Multiple Myeloma
    Gender:
    All
    Ages:
    18 Years-N/A
    Accepts healthy volunteers:
    No
    Listed location countries:
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Colombia
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Singapore
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    United States
    NCT number:
    NCT05827016
    Other study ID numbers:
    IM048-022
    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