NCT05827016Active, not recruitingPhase 3
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 Squibb700 sites in 6 countries1,230 target enrollmentStarted: June 22, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,230
- Locations
- 700
- Primary Endpoint
- Progression-free survival (PFS)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of symptomatic multiple myeloma (MM).
- •Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or
- •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.
Arms & Interventions
Arm A1: Iberdomide Dose 1
Experimental
Intervention: Iberdomide (Drug)
Arm A2: Iberdomide Dose 2
Experimental
Intervention: Iberdomide (Drug)
Arm A3: Iberdomide Dose 3
Experimental
Intervention: Iberdomide (Drug)
Arm B: Lenalidomide
Active Comparator
Intervention: Lenalidomide (Drug)
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to 6 years
Secondary Outcomes
- Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment(Up to 6 years)
- Area under the iberdomide plasma concentration-time curve from time zero to tau(Up to 1 year)
- Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)(Up to 1 year)
- Maximum iberdomide concentration (Cmax)(Up to 1 year)
- Achieving MRD negativity in participants with CR or better at any time after the date of randomization(Up to 6 years)
- Overall Survival(Up to 12 years)
- Time to maximum iberdomide plasma concentration (Tmax)(Up to 1 year)
- Recommended iberdomide dose for Stage 2(Up to 1 year)
- Number of participants with adverse events (AEs)(Up to 6 years)
- Progression-free survival on next line of treatment (PFS2)(Up to 6 years)
- Conversion from MRD positive to MRD negative in participants with CR or better(Up to 6 years)
- Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments(Up to 6 years)
- Time to progression (TTP)(Up to 6 years)
- Time to next treatment (TTNT)(Up to 6 years)
- Best response achieved prior to progressive disease (PD)(Up to 6 years)
- Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)(Up to 6 years)
- Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)(Up to 6 years)
Investigators
Study Sites (700)
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