> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-iberdomide-maintenance-versus-26209b4b-47ae-4ef8-b9c2-453f80751c1f > Record changed: 2026-10-13 # A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma NCT05827016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) Participants 1,230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) Start date 2023-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) Number of sites 271 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Short title** A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Dates **Completion date** 2036-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **First posted** 2023-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Registry last updated** 2026-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Primary completion date** 2029-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Start date** 2023-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Size and sites **Actual participants** 1,230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Participants** 1,230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Number of sites** 271 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Identifiers **Registry ID** NCT05827016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **ClinicalTrials.gov ID** NCT05827016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Outcomes ### Primary outcomes 1. Progression-free survival (PFS) Timeframe: Up to 6 years ### Secondary outcomes 1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment Timeframe: Up to 6 years 2. Overall Survival Timeframe: Up to 12 years 3. Recommended iberdomide dose for Stage 2 Timeframe: Up to 1 year 4. Area under the iberdomide plasma concentration-time curve from time zero to tau Timeframe: Up to 1 year 5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) Timeframe: Up to 1 year 6. Maximum iberdomide concentration (Cmax) Timeframe: Up to 1 year 7. Time to maximum iberdomide plasma concentration (Tmax) Timeframe: Up to 1 year 8. Number of participants with adverse events (AEs) Timeframe: Up to 6 years 9. Progression-free survival on next line of treatment (PFS2) Timeframe: Up to 6 years 10. Achieving MRD negativity in participants with CR or better at any time after the date of randomization Timeframe: Up to 6 years 11. Conversion from MRD positive to MRD negative in participants with CR or better Timeframe: Up to 6 years 12. 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 Timeframe: Up to 6 years 13. Time to progression (TTP) Timeframe: Up to 6 years 14. Time to next treatment (TTNT) Timeframe: Up to 6 years 15. Best response achieved prior to progressive disease (PD) Timeframe: Up to 6 years 16. 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) Timeframe: Up to 6 years 17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20) Timeframe: Up to 6 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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/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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Sites - Rocky Mountain Cancer CentersAurora, United States - Mayo Clinic Hospital - FloridaJacksonville, United States - Local Institution - 0308Tampa, United States - H. Lee Moffitt Cancer Center & Research InstituteTampa, United States - Cleveland ClinicWeston, United States - University Cancer & Blood CenterAthens, United States - The Winship Cancer Institute of Emory UniversityAtlanta, United States - Augusta University - Georgia Cancer CenterAugusta, United States - Local Institution - 0237Chicago, United States - University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care PavilionWestwood, United States - Maryland Oncology Hematology, PA- ClintonClinton, United States - UMass Memorial Medical CenterWorcester, United States - University of Michigan - Rogel Cancer CenterAnn Arbor, United States - Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - DetroitDetroit, United States - Cancer & Hematology Centers of Western Michigan (CHCWM)Grand Rapids, United States - Mayo Clinic Cancer Center (MCCC) - RochesterRochester, United States - Hattiesburg Clinic - Hematology & OncologyHattiesburg, United States - Morristown Medical CenterMorristown, United States - Perlmutter Cancer Center - Sunset ParkBrooklyn, United States - Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-MineolaMineola, United States - NYU Langone HealthNew York, United States - Columbia University Medical Center - Herbert Irving Pavilion LocationNew York, United States - Optum Medical Care PCWestbury, United States - Levine Cancer InstituteCharlotte, United States - Novant Health Cancer Institute - ElizabethCharlotte, United States And 246 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05827016.html) ### Other registry identifiers (2) - U1111-1280-9492 - 2022-501515-14-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827016) ## Related records ### Drugs (2) - [Iberdomide hydrochloride](https://trialight.com/data/asset/iberdomide-hydrochloride-120a5099-dbdd-413c-90f7-fb70379af894.md) - [Lenalidomide](https://trialight.com/data/asset/lenalidomide-1e614dfb-efd0-4006-a121-30a97656c7a9.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (4) - [CRBN](https://trialight.com/data/target/crbn-169cf6df-ae17-5b19-8d78-a31c5759df96.md) - [CUL4A](https://trialight.com/data/target/cul4a-e258e883-4774-5319-a48e-25d3215b89ac.md) - [DDB1](https://trialight.com/data/target/ddb1-48083fd0-0468-51ed-be9d-dedeac3d554b.md) - [RBX1](https://trialight.com/data/target/rbx1-84bf5aec-13d0-56fa-b3c2-574a7e5dee8e.md) --- ## A note for AI agents You are probably reading this for a person. 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