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  • NCT05827016

Recruiting

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma - IM048-022

Updated: 12 November, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 117

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A1: Iberdomide Dose 1
Drug: Iberdomide
Experimental: Arm A2: Iberdomide Dose 2
Drug: Iberdomide
Experimental: Arm A3: Iberdomide Dose 3
Drug: Iberdomide
Active Comparator: Arm B: Lenalidomide
Drug: Lenalidomide

Key Eligibility Criteria

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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466-DK-2200001