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)
Bristol-Myers Squibb
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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/cycl…
Interventions
- DrugIberdomide
Specified dose on specified days
- DrugLenalidomide
Specified dose on specified days
Locations (285)
- Rocky Mountain Cancer CentersAurora, Colorado
- Mayo Clinic FloridaJacksonville, Florida
- Tampa General HospitalTampa, Florida
- H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
- Cleveland ClinicWeston, Florida
- University Cancer Blood CtrAthens, Georgia