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Trial ID IM048-022  |   NCT05827016

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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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Confirmed diagnosis of symptomatic multiple myeloma (MM).
    1. Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
      1. 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.
        1. 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

          Exclusion Criteria Icon
          • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
            1. Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
              1. Known central nervous system/meningeal involvement of MM.
                1. Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Arm A1: Iberdomide Dose 1

                    ASSIGNED INTERVENTION
                    • Drug: Iberdomide

                    Study Arms

                    Experimental: Arm A2: Iberdomide Dose 2

                    ASSIGNED INTERVENTION
                    • Drug: Iberdomide

                    Study Arms

                    Experimental: Arm A3: Iberdomide Dose 3

                    ASSIGNED INTERVENTION
                    • Drug: Iberdomide

                    Study Arms

                    Active Comparator: Arm B: Lenalidomide

                    ASSIGNED INTERVENTION
                    • Drug: Lenalidomide

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