Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (EXCALIBER-RRMM)

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Full Title:
A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 3
Summary/Purpose:
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
Detailed Description:
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B). In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms: - Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd) - Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd) Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment. The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).
Treatments:
Drug : Dexamethasone

Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

Drug : Daratumumab

Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle

Drug : Bortezomib

Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

Drug : Iberdomide

Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle

Drug : Iberdomide

Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle

Drug : Iberdomide

Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle

Study Arms:
Experimental : Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Experimental : Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
Experimental : Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
Active Comparator : Daratumumab in combination with dexamethasone and bortezomib
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
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
  • Documented diagnosis of multiple myeloma (MM) and measurable disease.
  • Received 1 to 2 prior lines of anti-myeloma therapy.
  • Must have documented disease progression during or after their last anti-myeloma regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Exclusion Criteria
  • Any condition that confounds the ability to interpret data from the study.
  • Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
  • Known central nervous system involvement with MM.
  • Prior therapy with iberdomide.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
  • Locations / Centres:

    Tom Baker Cancer Centre, Calgary, Alberta – Recruiting

    Local Institution - 103, Edmonton, Alberta – Completed

    BC Cancer Agency, Fraser Valley Center, Surrey, British Columbia – Recruiting

    Local Institution - 104, Saint John, New Brunswick – Completed

    Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center, St John's, Newfoundland and Labrador – Recruiting

    Queen Elizabeth Ii Health Sciences Centre, Halifax, Nova Scotia – Recruiting

    Local Institution - 109, Ottawa, Quebec – Completed

    Local Institution - 107, Saskatoon, Saskatchewan – Completed

    CHU de Quebec-Universite Laval, Quebec, – Recruiting

    Contacts:
    Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
    Phone: 855-907-3286
    Email: [email protected]
    Publications:
    ???
    First posted:
    2021-07-26
    Actual start date:
    June 23, 2022
    Last updated:
    2024-04-09
    Estimated enrollment:
    864
    Estimated completion date:
    2032-06-25
    Estimated primary completion date:
    2026-03-18
    Condition:
    Multiple Myeloma
    Gender:
    All
    Ages:
    18 Years-N/A
    Accepts healthy volunteers:
    No
    Listed location countries:
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    China
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    United States
    NCT number:
    NCT04975997
    Other study ID numbers:
    CC-220-MM-002
    Has Data monitoring committee:
    Yes
    U.S. FDA-regulated product:
    Yes
    IPD Sharing Statement :
    ???
    Responsible party:
    Sponsor
    Study sponsor:
    lead_sponsor
    Celgene
    Industry
    Collaborators:
    ???
    Investigators:
    Bristol-Myers Squibb Bristol-Myers Squibb
    Protocol Registration and Results System:
    ???
    Verification date:
    2024-04-01