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Trial ID CC-220-MM-002  |   NCT04975997

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 123
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Documented diagnosis of multiple myeloma (MM) and measurable disease.
    1. Received 1 to 2 prior lines of anti-myeloma therapy.
      1. Must have documented disease progression during or after their last anti-myeloma regimen.
        1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Any condition that confounds the ability to interpret data from the study.
            1. Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
              1. Known central nervous system involvement with MM.
                1. Prior therapy with iberdomide.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Active Comparator: Daratumumab in combination with dexamethasone and bortezomib

                    ASSIGNED INTERVENTION
                    • Drug: Daratumumab, Bortezomib, Dexamethasone

                    Study Arms

                    Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1

                    ASSIGNED INTERVENTION
                    • Drug: Daratumumab, Iberdomide, Dexamethasone

                    Study Arms

                    Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2

                    ASSIGNED INTERVENTION
                    • Drug: Daratumumab, Iberdomide, Dexamethasone

                    Study Arms

                    Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3

                    ASSIGNED INTERVENTION
                    • Drug: Dexamethasone, Daratumumab, Iberdomide
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