Study Comparing Iberdomide and Lenalidomide Maintenance Therapy After Stem Cell Transplant in Newly Diagnosed Multiple Myeloma Patients

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT05827016

This clinical trial is evaluating whether iberdomide or lenalidomide is more effective as a maintenance therapy for patients with newly diagnosed multiple myeloma who have undergone a stem cell transplant.

Patient Parameters

Program Overview

The goal of this study is to determine which maintenance therapy, iberdomide or lenalidomide, is more effective in helping patients with newly diagnosed multiple myeloma maintain their health after receiving an autologous stem cell transplant. This study will help doctors understand which treatment option provides better outcomes for patients in maintaining remission and improving quality of life after the transplant.

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, daratumumab + bortezomib/thalidomide/dexamethasone [D-VTd] and daratumumab + bortezomib/ lenalidomide/dexamethasone [D-VRd]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone [D-VCd], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
  • Participants within 12 months (single transplant) or 15 months (tandem transplant) 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.

Locations

FACILITYZIPCITYSTATE
Rocky Mountain Cancer Centers80012-5405AuroraColorado
Mayo Clinic Florida32224JacksonvilleFlorida
Tampa General Hospital33606TampaFlorida
H. Lee Moffitt Cancer Center & Research Institute33612-9416TampaFlorida
Cleveland Clinic33331-3609WestonFlorida
University Cancer Blood Ctr30607-1465AthensGeorgia
The Winship Cancer Institute of Emory University30322-1013AtlantaGeorgia
Augusta University - Georgia Cancer Center30912AugustaGeorgia
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine60637-1426ChicagoIllinois
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion66205-2003WestwoodKansas

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