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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Iberdomide
* Drug: Lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A1: Iberdomide Dose 1<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: BMS-986382;|
| Experimental: Arm A2: Iberdomide Dose 2<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: BMS-986382;|
| Experimental: Arm A3: Iberdomide Dose 3<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: BMS-986382;|
| Active Comparator: Arm B: Lenalidomide<br> | Drug: Lenalidomide<br>* Specified dose on specified days<br>* Other names: Revlimid®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall Survival |  | Up to 12 years | 
| Recommended iberdomide dose for Stage 2 |  | Up to 1 year | 
| 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 | 
| Time to maximum iberdomide plasma concentration (Tmax) |  | 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 | 
| Achieving MRD negativity in participants with CR or better at any time after the date of randomization |  | 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 6 months or 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MM, Multiple Myeloma, Iberdomide, CC-220, Lenalidomide, NDMM, Maintenance, Autologous stem cell transplant, ASCTm