Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
EXCALIBER-RRMM
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)
3 other identifiers
interventional
864
30 countries
247
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Jun 2022
Longer than P75 for phase_3 multiple-myeloma
247 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedStudy Start
First participant enrolled
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2032
ExpectedJuly 10, 2025
July 1, 2025
3.7 years
July 2, 2021
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free Survival (PFS)
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).
Up to approximately 5 years
Minimal Residual Disease (MRD) negative Complete Response (CR) at any time
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.
Up to approximately 5 years
Secondary Outcomes (15)
Overall Survival (OS)
Up to approximately 5 years
Sustainability of Minimal Residual Disease (MRD) negativity
Up to approximately 5 years
Overall Response Rate (ORR)
Up to approximately 5 years
Time to response (TTR)
Up to approximately 5 years
Duration of Response (DoR)
Up to approximately 5 years
- +10 more secondary outcomes
Study Arms (4)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
EXPERIMENTALParticipants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
EXPERIMENTALDaratumumab in combination with Iberdomide and dexamethasone - Dose 3
EXPERIMENTALDaratumumab in combination with dexamethasone and bortezomib
ACTIVE COMPARATORParticipants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Interventions
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle
Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (259)
Local Institution - 035
Hot Springs, Arkansas, 71913, United States
Local Institution - 641
Cerritos, California, 90703-2679, United States
Local Institution - 681
Fountain Valley, California, 92708, United States
Local Institution - 047
Los Angeles, California, 90033, United States
Local Institution - 684
Newport, California, 92663, United States
Local Institution - 033
New Haven, Connecticut, 06511, United States
Local Institution - 029
Fort Myers, Florida, 33901, United States
Local Institution - 693
Ocala, Florida, 34471-6950, United States
Local Institution - 028
St. Petersburg, Florida, 33705, United States
Local Institution - 045
Tamarac, Florida, 33321-2909, United States
Local Institution - 034
West Palm Beach, Florida, 33401, United States
Local Institution - 685
Weston, Florida, 33331-3609, United States
Local Institution - 018
Atlanta, Georgia, 30322, United States
Local Institution - 640
Elk Grove Village, Illinois, 60007-3363, United States
Local Institution - 697
Dyer, Indiana, 46311-1596, United States
Local Institution - 040
Louisville, Kentucky, 40207, United States
Local Institution - 041
Alexandria, Louisiana, 71301-3841, United States
Local Institution - 682
Baton Rouge, Louisiana, 70808-4300, United States
Local Institution - 027
Baton Rouge, Louisiana, 70809-3675, United States
Local Institution - 698
Baltimore, Maryland, 21204-6826, United States
Local Institution - 014
Bethesda, Maryland, 20817, United States
Local Institution - 688
Columbia, Maryland, 21044-3128, United States
Local Institution - 010
Boston, Massachusetts, 02215, United States
Local Institution - 009
Worcester, Massachusetts, 01655, United States
Local Institution - 645
Burnsville, Minnesota, 55337-6749, United States
Local Institution - 031
Kansas City, Missouri, 64132, United States
Local Institution - 046
Billings, Montana, 59102-6746, United States
Local Institution - 015
Summit, New Jersey, 07901, United States
Local Institution - 691
New York, New York, 10016, United States
Local Institution - 039
Durham, North Carolina, 27705, United States
Local Institution - 038
Cincinnati, Ohio, 45220, United States
Local Institution - 037
Cleveland, Ohio, 44109, United States
Local Institution - 008
Cleveland, Ohio, 44195, United States
Local Institution - 036
Columbus, Ohio, 43214, United States
Local Institution - 680
Tulsa, Oklahoma, 74146-6236, United States
Local Institution - 043
Portland, Oregon, 97239, United States
Local Institution - 030
Chattanooga, Tennessee, 37404, United States
Local Institution - 021
Nashville, Tennessee, 37203, United States
Local Institution - 687
Austin, Texas, 78705-1165, United States
Local Institution - 695
Houston, Texas, 77025, United States
Local Institution - 642
Newport News, Virginia, 23606-3069, United States
Local Institution - 643
Roanoke, Virginia, 24014-2419, United States
Local Institution - 025
Madison, Wisconsin, 53705, United States
Local Institution - 080
Ciudad Autanoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
Local Institution - 083
Villa Elisa, Buenos Aires, B1894, Argentina
Local Institution - 813
Birtinya, Queensland, 4575, Australia
Local Institution - 812
Douglas, Queensland, 4814, Australia
Local Institution - 803
Adelaide, South Australia, 5000, Australia
Local Institution - 806
Bedford Park, South Australia, 5042, Australia
Local Institution - 802
Clayton, Victoria, 3168, Australia
Local Institution - 809
East Melbourne, Victoria, 3001, Australia
Local Institution - 801
Melbourne, Victoria, 3004, Australia
Local Institution - 811
Murdoch, Western Australia, 6150, Australia
Local Institution - 807
West Perth, Western Australia, 6005, Australia
Local Institution - 804
Camperdown, 2050, Australia
Local Institution - 800
Fitzroy, 3065, Australia
Local Institution - 808
Garran, ACT 2605, Australia
Local Institution - 155
Graz, 73013, Austria
Local Institution - 154
Linz, 4010, Austria
Local Institution - 153
Salzburg, 5020, Austria
Local Institution - 156
Sankt Pölten, 3100, Austria
Local Institution - 150
Vienna, 1090, Austria
Local Institution - 151
Vienna, 1160, Austria
Local Institution - 172
Bruges, 8000, Belgium
Local Institution - 174
Brussels, 1200, Belgium
Local Institution - 056
Curitiba, Paraná, 80530-010, Brazil
Local Institution - 050
Porto Alegre, Rio Grande do Sul, 90460-030, Brazil
Local Institution - 058
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution - 051
Barretos, São Paulo, 14784-400, Brazil
Local Institution - 054
Jaú, São Paulo, 17210-080, Brazil
Local Institution - 055
São Paulo, São Paulo, 05403000, Brazil
Local Institution - 053
Rio de Janeiro, 22793-080, Brazil
Local Institution - 057
São Paulo, 01509-900, Brazil
Local Institution - 052
São Paulo, 04537-080, Brazil
Local Institution - 111
Calgary, Alberta, T2N 4N2, Canada
Local Institution - 103
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution - 112
Surrey, British Columbia, V3V 1Z2, Canada
Local Institution - 104
Saint John, New Brunswick, E2L 3L6, Canada
Local Institution - 110
St. John's, Newfoundland and Labrador, A1B3V6, Canada
Local Institution - 101
Halifax, Nova Scotia, B3H 1V7, Canada
Local Institution - 109
Ottawa, Quebec, K1H 8L6, Canada
Local Institution - 108
Québec, Quebec, G1J 1Z4, Canada
Local Institution - 107
Saskatoon, Saskatchewan, S7N-0W8, Canada
Local Institution - 141
Changsha, Hunan, 410013, China
Local Institution - 129
Nanchang, Jiangxi, 330008, China
Local Institution - 143
Xi'an, Shaanxi, 710004, China
Local Institution - 142
Shanghai, Shanghai Municipality, 200434, China
Local Institution - 145
Taiyuan, Shanxi, 030032, China
Local Institution - 144
Wenzhou, Zhejiang, 325000, China
Local Institution - 140
Beijing, 100071, China
Local Institution - 139
Beijing, 100191, China
Local Institution - 138
Beijing, 100730, China
Local Institution - 126
Changchun, 130021, China
Local Institution - 121
Chaoyang District, 100020, China
Local Institution - 135
Guangzhou, 510030, China
Local Institution - 136
Guangzhou, 510060, China
Local Institution - 128
Hangzhou, 310006, China
Local Institution - 120
Hangzhou, Zhejiang, 310006, China
Local Institution - 127
Harbin, 150081, China
Local Institution - 134
Nanjing, 210029, China
Local Institution - 132
Shanghai, 200025, China
Local Institution - 130
Shanghai, 200032, China
Local Institution - 131
Shenyang, 110004, China
Local Institution - 124
Suzhu, 215006, China
Local Institution - 133
Tianjin, 300020, China
Local Institution - 137
Wuhan, 430030, China
Local Institution - 125
Xi'an, 710000, China
Local Institution - 123
Zhengzhou, 0, China
Local Institution - 601
Brno, 625 00, Czechia
Local Institution - 600
Ostrava-Poruba, 708 52, Czechia
Local Institution - 602
Prague, 128 08, Czechia
Local Institution - 371
Aalborg, 9000, Denmark
Local Institution - 370
Odense, 5000, Denmark
Local Institution - 372
Roskilde, 4000, Denmark
Local Institution - 231
Turku, Southwest Finland, 20521, Finland
Local Institution - 230
Helsinki, 290, Finland
Local Institution - 232
Oulu, 90220, Finland
Local Institution - 463
Argenteuil, 95100, France
Local Institution - 462
La Roche-sur-Yon, 85925, France
Local Institution - 451
Lille, 59037, France
Local Institution - 458
Nancy, 54511, France
Local Institution - 454
Nantes, 44093, France
Local Institution - 456
Paris, 75013, France
Local Institution - 452
Paris, 75475, France
Local Institution - 464
Pessac, 33604, France
Local Institution - 465
Rouen, 76038, France
Local Institution - 457
Toulouse, 31059, France
Local Institution - 308
Kiel, Schleswig-Holstein, 24105, Germany
Local Institution - 301
Frankfurt am Main, 60590, Germany
Local Institution - 300
Hamburg, 20246, Germany
Local Institution - 302
Hamburg, 22763, Germany
Local Institution - 305
Heidelberg, 69120, Germany
Local Institution - 304
Lübeck, 23562, Germany
Local Institution - 573
Pátrai, Achaea, 26054, Greece
Local Institution - 574
Pátrai, Achaia, 264 43, Greece
Local Institution - 571
Athens, 115 28, Greece
Local Institution - 572
Thessaloniki, 54007, Greece
Local Institution - 570
Thessaloniki, 57010, Greece
Local Institution - 932
Hyderabad, Andhra Pradesh, 500084, India
Local Institution - 930
Bangalore, Karnataka, 560054, India
Local Institution - 934
Ernākulam, Kerala, 682041, India
Local Institution - 933
Mumbai, Maharashtra, 400036, India
Local Institution - 935
Kolkata, West Bengal, 700014, India
Local Institution - 931
Puducherry, 605006, India
Local Institution - 752
Cork, T12 DFK4, Ireland
Local Institution - 750
Dublin, D09 V2N0, Ireland
Local Institution - 751
Galway, H91 YR71, Ireland
Local Institution - 874
Afula, Northern District, 18101, Israel
Local Institution - 872
Haifa, 35254, Israel
Local Institution - 871
Jerusalem, 91120, Israel
Local Institution - 870
Tel Aviv, 64239, Israel
Local Institution - 873
Tel Litwinsky, 52621, Israel
Local Institution - 415
Rome, Lazio, 00193, Italy
Local Institution - 400
Bologna, 40138, Italy
Local Institution - 408
Catania, 95124, Italy
Local Institution - 414
Genova, 16132, Italy
Local Institution - 404
Milan, 20122, Italy
Local Institution - 410
Novara, 28100, Italy
Local Institution - 412
Pavia, 27100, Italy
Local Institution - 402
Pisa, 56126, Italy
Local Institution - 405
Reggio Calabria, 89100, Italy
Local Institution - 401
Roma, 00189, Italy
Local Institution - 403
San Giovanni Rotondo FG, 71013, Italy
Local Institution - 406
Udine, 33100, Italy
Local Institution - 900
Matsuyama, Ehime, 790-8524, Japan
Local Institution - 917
Higashi-Ibaraki-gun, Ibaraki, 311-3193, Japan
Local Institution - 919
Shimotsuga, Tochigi, 321-0293, Japan
Local Institution - 920
Nerima-ku, Tokyo, 179-0072, Japan
Local Institution - 918
Shinagawa-ku, Tokyo, 142-8666, Japan
Local Institution - 915
Chuo-shi, Yamanashi, 4093898, Japan
Local Institution - 912
Aomori, 030-8553, Japan
Local Institution - 916
Chiba, 260-8717, Japan
Local Institution - 911
Fukuoka, 810-8563, Japan
Local Institution - 903
Kamogawa, 296-8602, Japan
Local Institution - 902
Kyoto, 602-8566, Japan
Local Institution - 910
Nagoya, 464-8681, Japan
Local Institution - 901
Nagoya, 467-8602, Japan
Local Institution - 905
Okayama, 701-1192, Japan
Local Institution - 907
Osaka, 545-8585, Japan
Local Institution - 908
Ōsaka-sayama, 589-8511, Japan
Local Institution - 913
Sapporo, 003-0006, Japan
Local Institution - 914
Sendai, 980-8574, Japan
Local Institution - 906
Shibuya-ku, 150-8935, Japan
Local Institution - 909
Shinagawa-ku, Tokyo, 141-8625, Japan
Local Institution - 904
Toyohashi, 441-8570, Japan
Local Institution - 183
Guadalajara, Jalisco, 44600, Mexico
Local Institution - 351
Dordrecht, South Holland, 3318 AT, Netherlands
Local Institution - 354
Amsterdam, 1081 HV, Netherlands
Local Institution - 352
The Hague, 2545 CH, Netherlands
Local Institution - 202
Bergen, N-5053, Norway
Local Institution - 200
Oslo, 0450, Norway
Local Institution - 201
Trondheim, 7030, Norway
Local Institution - 631
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Local Institution - 633
Krakow, 30-688, Poland
Local Institution - 635
Nowy Sącz, 33-300, Poland
Local Institution - 634
Poznan, 60-569, Poland
Local Institution - 630
Warsaw, 02-781, Poland
Local Institution - 636
Wałbrzych, 58-309, Poland
Local Institution - 545
Coimbra, 4200-072, Portugal
Local Institution - 543
Lisbon, 1099-023, Portugal
Local Institution - 544
Lisbon, 1400-038, Portugal
Local Institution - 540
Porto, 4200-072, Portugal
Local Institution - 541
Porto, 4200-319, Portugal
Local Institution - 974
Daegu, 700-721, South Korea
Local Institution - 973
Gyeonggi-do, 410-769, South Korea
Local Institution - 975
Hwasun-gun, 519-809, South Korea
Local Institution - 971
Seoul, 06351, South Korea
Local Institution - 976
Seoul, 06591, South Korea
Local Institution - 972
Seoul, 120-752, South Korea
Local Institution - 970
Seoul, 3080, South Korea
Local Institution - 977
Seoul, 5505, South Korea
Local Institution - 514
Pamplona, Navarre, 31008, Spain
Local Institution - 505
Barcelona, 08025, Spain
Local Institution - 502
Barcelona, 08035, Spain
Local Institution - 511
Barcelona, 08916, Spain
Local Institution - 501
Cáceres, 10005, Spain
Local Institution - 509
Córdoba, 14001, Spain
Local Institution - 510
Madrid, 28006, Spain
Local Institution - 516
Madrid, 28027, Spain
Local Institution - 504
Madrid, 28034, Spain
Local Institution - 513
Madrid, 28040, Spain
Local Institution - 503
Málaga, 29010, Spain
Local Institution - 508
Murcia, 30120, Spain
Local Institution - 506
Oviedo, 33011, Spain
Local Institution - 515
Salamanca, 37007, Spain
Local Institution - 500
Santiago de Compostela, 15706, Spain
Local Institution - 512
Valencia, 46026, Spain
Local Institution - 507
Zaragoza, 50009, Spain
Local Institution - 272
Borås, 50182, Sweden
Local Institution - 271
Helsingborg, 25437, Sweden
Local Institution - 851
Chur, 7000, Switzerland
Local Institution - 850
Sankt Gallen, CH-9007, Switzerland
Local Institution - 955
Niao-Sung Hsiang Kaohsiung County, 83301, Taiwan
Local Institution - 952
Taichung, 40447, Taiwan
Local Institution - 954
Taichung, 407219, Taiwan
Local Institution - 951
Tainan, Taiana, 704, Taiwan
Local Institution - 950
Taipei, 11217, Taiwan
Local Institution - 956
Taipei, Zhongzheng Dist., 10002, Taiwan
Local Institution - 953
Taoyuan, 33305, Taiwan
Local Institution - 778
Kavaklıdere, Ankara, 06680, Turkey (Türkiye)
Local Institution - 776
Yenimahalle, Ankara, 6200, Turkey (Türkiye)
Local Institution - 777
Pendik, Istanbul, 34899, Turkey (Türkiye)
Local Institution - 771
Balçova, İzmir, 35340, Turkey (Türkiye)
Local Institution - 775
Bornova, İzmir, 35100, Turkey (Türkiye)
Local Institution - 773
Samsun, Kurupelit, 55239, Turkey (Türkiye)
Local Institution - 770
Ankara, 06100, Turkey (Türkiye)
Local Institution - 772
Gaziantep, 27310, Turkey (Türkiye)
Local Institution - 774
Kayseri, 38140, Turkey (Türkiye)
Local Institution - 702
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Local Institution - 705
Belfast Northern Ireland, BT9 7AD, United Kingdom
Local Institution - 700
Birmingham, B15 2TH, United Kingdom
Local Institution - 707
Canterbury Kent, CT1 3NG, United Kingdom
Local Institution - 704
Lancashire Blackpool, FY3 8NR, United Kingdom
Local Institution - 701
London, NW1 2BU, United Kingdom
Local Institution - 709
London, SE1 9RT, United Kingdom
Local Institution - 706
Oxford, OX3 7LE, United Kingdom
Local Institution - 711
Portsmouth, PO6 3LY, United Kingdom
Local Institution - 713
Sutton, SM2 5PT, United Kingdom
Local Institution - 708
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Lonial S, Dimopoulos MA, Berdeja JG, Richardson PG, Quach H, Rodriguez-Otero P, Maciag P, Hong K, Amatangelo M, Chen M, van de Donk NWCJ. EXCALIBER-RRMM: a phase III trial of iberdomide, daratumumab, and dexamethasone in relapsed/refractory multiple myeloma. Future Oncol. 2025 Jun;21(14):1761-1769. doi: 10.1080/14796694.2025.2501920. Epub 2025 May 10.
PMID: 40346992DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 26, 2021
Study Start
June 23, 2022
Primary Completion
March 18, 2026
Study Completion (Estimated)
June 25, 2032
Last Updated
July 10, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/