> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-study-comparing-iberdomide-daratumumab-and-09c0360e-cfc5-4d57-9beb-448074ada599 > Record changed: 2026-11-04 # Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) NCT04975997 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) Participants 939 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) Lead sponsor Celgene Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) Start date 2022-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) Number of sites 259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Title and summary **Summary** This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Acronym** EXCALIBER-RRMM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Short title** Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Official title** A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Dates **Completion date** 2032-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **First posted** 2021-07-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Registry last updated** 2026-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Primary completion date** 2027-11-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Start date** 2022-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Size and sites **Actual participants** 939 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Participants** 939 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Number of sites** 259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Lead sponsor** Celgene Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Identifiers **Registry ID** NCT04975997 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **ClinicalTrials.gov ID** NCT04975997 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Outcomes ### Primary outcomes 1. Progression-free Survival (PFS) Timeframe: Up to approximately 5 years To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS). 2. Minimal Residual Disease (MRD) negative Complete Response (CR) at any time Timeframe: Up to approximately 5 years To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time. ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to approximately 5 years To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd). 2. Sustainability of Minimal Residual Disease (MRD) negativity Timeframe: Up to approximately 5 years To evaluate the sustainability of minimal residual disease (MRD) negativity. 3. Overall Response Rate (ORR) Timeframe: Up to approximately 5 years Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma. 4. Time to response (TTR) Timeframe: Up to approximately 5 years Time from randomization to the first documentation of response (PR or better). 5. Duration of Response (DoR) Timeframe: Up to approximately 5 years Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. 6. Time to Progression (TTP) Timeframe: Up to approximately 5 years The time from randomization to the first documented disease progression. 7. Time to Next Treatment (TTNT) Timeframe: Up to approximately 5 years Time from randomization to the start of the next antimyeloma treatment. 8. Progression-free Survival 2 (PFS2) Timeframe: Up to approximately 5 years Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first. 9. Safety Timeframe: Up to approximately 5 years Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment. 10. European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Timeframe: Up to approximately 5 years Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30. 11. European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) Timeframe: Up to approximately 5 years EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20. 12. Recommended iberdomide dose for Stage 2 Timeframe: Up to approximately 1 year 13. Area under the plasma concentration-time curve from time zero to tau (AUC(TAU)) Timeframe: Up to approximately 1 year 14. Maximum plasma concentration (Cmax) Timeframe: Up to approximately 1 year 15. Time to maximum plasma concentration (Tmax) Timeframe: Up to approximately 1 year Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Documented diagnosis of multiple myeloma (MM) and measurable disease. - Received 1 to 2 prior lines of anti-myeloma therapy. - Must have documented disease progression during or after their last anti-myeloma regimen. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. ### Exclusion criteria - Any condition that confounds the ability to interpret data from the study. - Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis. - Known central nervous system involvement with MM. - Prior therapy with iberdomide. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Sites - Local Institution - 035Hot Springs, United States - Local Institution - 641Cerritos, United States - Local Institution - 681Fountain Valley, United States - Local Institution - 047Los Angeles, United States - Local Institution - 684Newport, United States - Local Institution - 033New Haven, United States - Local Institution - 029Fort Myers, United States - Local Institution - 693Ocala, United States - Local Institution - 028St. Petersburg, United States - Local Institution - 045Tamarac, United States - Local Institution - 034West Palm Beach, United States - Local Institution - 685Weston, United States - Local Institution - 018Atlanta, United States - Local Institution - 640Elk Grove Village, United States - Local Institution - 697Dyer, United States - Local Institution - 040Louisville, United States - Local Institution - 041Alexandria, United States - Local Institution - 682Baton Rouge, United States - Local Institution - 027Baton Rouge, United States - Local Institution - 698Baltimore, United States - Local Institution - 014Bethesda, United States - Local Institution - 688Columbia, United States - Local Institution - 010Boston, United States - Local Institution - 009Worcester, United States - Local Institution - 645Burnsville, United States And 234 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## References - PubMed 40346992 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40346992/) Related publication - 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/NCT04975997.html) ### Other registry identifiers (2) - U1111-1260-2872 - 2020-000431-49 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975997) ## Related records ### Drugs (4) - [Bortezomib](https://trialight.com/data/asset/bortezomib-35a853cf-26ab-4a4c-a405-ae671d364aad.md) - [Daratumumab](https://trialight.com/data/asset/daratumumab-28c327e5-1741-4dd5-89d4-6562e941ab50.md) - [Dexamethasone](https://trialight.com/data/asset/dexamethasone-b923ddae-f095-408c-96e9-975238a429ad.md) - [Iberdomide](https://trialight.com/data/asset/iberdomide-c87e8a0b-9d3e-422e-9876-8c8310fab473.md) ### Lead sponsors (1) - [Celgene](https://trialight.com/data/company/celgene-8cc1af71-76e6-441c-bad9-b2ad3b0321b1.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (45) - [ADRM1](https://trialight.com/data/target/adrm1-21aacba2-e414-54a6-9f55-4bf543c44c62.md) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) - [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) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) - [PSMA1](https://trialight.com/data/target/psma1-1a956ca8-78e9-55cf-b44b-560f5cfb1ba8.md) - [PSMA2](https://trialight.com/data/target/psma2-b6cdbdc0-82f0-5196-899c-7b9432c6cdda.md) - [PSMA3](https://trialight.com/data/target/psma3-a2764924-6b4d-5acf-9eff-dbea2141aa2f.md) - [PSMA4](https://trialight.com/data/target/psma4-593e4b71-d38d-502d-8b54-c8007dcaa3fd.md) - [PSMA5](https://trialight.com/data/target/psma5-b00fc409-cd81-57ea-a85a-fe4cb526fcb3.md) - [PSMA6](https://trialight.com/data/target/psma6-bad5198f-7678-5327-b1ac-6a30d99e444d.md) - [PSMA7](https://trialight.com/data/target/psma7-b2a4597f-767f-5e0d-9db6-b84884d029a3.md) - [PSMA8](https://trialight.com/data/target/psma8-fe91f265-3b28-517b-a83f-80ecefdabadb.md) - [PSMB1](https://trialight.com/data/target/psmb1-3b057ce7-508d-57c4-a183-4fe8471ad0ef.md) - [PSMB10](https://trialight.com/data/target/psmb10-44bce842-f863-5480-936a-3f039f83fc4d.md) - [PSMB11](https://trialight.com/data/target/psmb11-d76fbce1-5b6a-50fc-88d6-5e31b147d0a3.md) - [PSMB2](https://trialight.com/data/target/psmb2-d67cfad8-2c3c-5c37-ae3e-74f480c7f6d1.md) - [PSMB3](https://trialight.com/data/target/psmb3-062cecb0-b4fa-5d3a-987f-d5525d28dd23.md) --- ## A note for AI agents You are probably reading this for a person. 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