Clinical Trial 22256

• Overview

  Study Title:

  A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Treatment after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)

  Summary:

  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).

  Objective:

  Primary Objective: To compare the efficacy of iberdomide versus lenalidomide in participants with NDMM after ASCT, as measured by PFS. Secondary Objectives: In Stage 1, to inform the dose of iberdomide to continue in Stage 2 of the study. In Stage 1, to assess the PK of iberdomide. To evaluate safety of iberdomide maintenance compared to lenalidomide maintenance in participants with NDMM after ASCT. To evaluate PFS on next line of treatment (PFS2) in participants with NDMM after ASCT when treated with iberdomide compared to lenalidomide. To compare the overall rate of MRD negativity (at a threshold of 10^-5 by next-generation flow) of iberdomide versus lenalidomide maintenance treatment in participants with a response of CR or better. To evaluate the frequency of conversion from MRD-positive to MRD-negative in participants with a response of CR or better (at a threshold of 10^-5 by next-generation flow), in participants with NDMM after ASCT when treated with iberdomide compared to lenalidomide. To evaluate the sustainability of MRD negativity (at a threshold of 10^-5 by nextgeneration flow), in participants with NDMM after ASCT when treated with iberdomide compared to lenalidomide. To evaluate TTP in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide. To evaluate TTNT in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide. To evaluate the percentage of participants in the study with a response of PR improving to VGPR or better and those with VGPR achieving CR or sCR as well as maintaining best overall response for participants who enroll in the study at CR. To evaluate cancer-related symptoms, multiple myeloma-specific symptoms, and HRQoL in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide.

• Treatments

  Therapies:

  Immunomodulators

  Medications:

  CC-5013 (Lenalidomide); Iberdomide (); Lenalidomide (Revlimid)

• Inclusion 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.

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