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Official Title

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

Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Enrollment
1,216
Timeline
Jun 2023 → Jan 2036
About This Study

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).

Eligibility Criteria

Inclusion Criteria

  • 1Confirmed diagnosis of symptomatic multiple myeloma (MM).
  • 2Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
  • 3Received 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.
  • 4Participants 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

  • 1Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
  • 2Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
  • 3Known central nervous system/meningeal involvement of MM.
  • 4Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.

Locations

285 sites participating in this study

The Winship Cancer Institute of Emory University

Atlanta, Georgia 30322-1013

Recruiting

Sagar Lonial, Site 0018

404-778-1900

Rocky Mountain Cancer Centers

Aurora, Colorado 80012-5405

Recruiting

John Burke, Site 0202

303-925-0700

Mayo Clinic Florida

Jacksonville, Florida 32224

Recruiting

Sikander Ailawadhi, Site 0007

904-953-0853
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →