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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Iberdomide; Drug: Iberdomide; Drug: Iberdomide; Drug: Bortezomib; Drug: Daratumumab; Drug: Dexamethasone; Drug: Daratumumab

Detailed Description

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). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

• Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
• Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

• Study Type: Interventional
• Enrollment (Actual): 939
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autanoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
      • Local Institution - 080
    • Villa Elisa, Buenos Aires, Argentina, B1894
      • Local Institution - 083
• Australia
  • Camperdown, Australia, 2050
    • Local Institution - 804
  • Fitzroy, Australia, 3065
    • Local Institution - 800
  • Garran, Australia, ACT 2605
    • Local Institution - 808
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Local Institution - 813
    • Douglas, Queensland, Australia, 4814
      • Local Institution - 812
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 803
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution - 806
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 802
    • East Melbourne, Victoria, Australia, 3001
      • Local Institution - 809
    • Melbourne, Victoria, Australia, 3004
      • Local Institution - 801
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Local Institution - 811
    • West Perth, Western Australia, Australia, 6005
      • Local Institution - 807
• Austria
  • Graz, Austria, 73013
    • Local Institution - 155
  • Linz, Austria, 4010
    • Local Institution - 154
  • Salzburg, Austria, 5020
    • Local Institution - 153
  • Sankt Pölten, Austria, 3100
    • Local Institution - 156
  • Vienna, Austria, 1090
    • Local Institution - 150
  • Vienna, Austria, 1160
    • Local Institution - 151
• Belgium
  • Bruges, Belgium, 8000
    • Local Institution - 172
  • Brussels, Belgium, 1200
    • Local Institution - 174
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Local Institution - 053
  • São Paulo, Brazil, 01509-900
    • Local Institution - 057
  • São Paulo, Brazil, 04537-080
    • Local Institution - 052
  • Paraná
    • Curitiba, Paraná, Brazil, 80530-010
      • Local Institution - 056
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90460-030
      • Local Institution - 050
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Local Institution - 058
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Local Institution - 051
    • Jaú, São Paulo, Brazil, 17210-080
      • Local Institution - 054
    • São Paulo, São Paulo, Brazil, 05403000
      • Local Institution - 055
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Local Institution - 111
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 103
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • Local Institution - 112
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 3L6
      • Local Institution - 104
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B3V6
      • Local Institution - 110
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Local Institution - 101
  • Quebec
    • Ottawa, Quebec, Canada, K1H 8L6
      • Local Institution - 109
    • Québec, Quebec, Canada, G1J 1Z4
      • Local Institution - 108
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N-0W8
      • Local Institution - 107
• China
  • Beijing, China, 100071
    • Local Institution - 140
  • Beijing, China, 100191
    • Local Institution - 139
  • Beijing, China, 100730
    • Local Institution - 138
  • Changchun, China, 130021
    • Local Institution - 126
  • Chaoyang District, China, 100020
    • Local Institution - 121
  • Guangzhou, China, 510030
    • Local Institution - 135
  • Guangzhou, China, 510060
    • Local Institution - 136
  • Hangzhou, China, 310006
    • Local Institution - 128
  • Hangzhou, Zhejiang, China, 310006
    • Local Institution - 120
  • Harbin, China, 150081
    • Local Institution - 127
  • Nanjing, China, 210029
    • Local Institution - 134
  • Shanghai, China, 200025
    • Local Institution - 132
  • Shanghai, China, 200032
    • Local Institution - 130
  • Shenyang, China, 110004
    • Local Institution - 131
  • Suzhu, China, 215006
    • Local Institution - 124
  • Tianjin, China, 300020
    • Local Institution - 133
  • Wuhan, China, 430030
    • Local Institution - 137
  • Xi'an, China, 710000
    • Local Institution - 125
  • Zhengzhou, China
    • Local Institution - 123
  • Hunan
    • Changsha, Hunan, China, 410013
      • Local Institution - 141
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • Local Institution - 129
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Local Institution - 143
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200434
      • Local Institution - 142
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Local Institution - 145
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Local Institution - 144
• Czechia
  • Brno, Czechia, 625 00
    • Local Institution - 601
  • Ostrava-Poruba, Czechia, 708 52
    • Local Institution - 600
  • Prague, Czechia, 128 08
    • Local Institution - 602
• Denmark
  • Aalborg, Denmark, 9000
    • Local Institution - 371
  • Odense, Denmark, 5000
    • Local Institution - 370
  • Roskilde, Denmark, 4000
    • Local Institution - 372
• Finland
  • Helsinki, Finland, 290
    • Local Institution - 230
  • Oulu, Finland, 90220
    • Local Institution - 232
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20521
      • Local Institution - 231
• France
  • Argenteuil, France, 95100
    • Local Institution - 463
  • La Roche-sur-Yon, France, 85925
    • Local Institution - 462
  • Lille, France, 59037
    • Local Institution - 451
  • Nancy, France, 54511
    • Local Institution - 458
  • Nantes, France, 44093
    • Local Institution - 454
  • Paris, France, 75013
    • Local Institution - 456
  • Paris, France, 75475
    • Local Institution - 452
  • Pessac, France, 33604
    • Local Institution - 464
  • Rouen, France, 76038
    • Local Institution - 465
  • Toulouse, France, 31059
    • Local Institution - 457
• Germany
  • Frankfurt am Main, Germany, 60590
    • Local Institution - 301
  • Hamburg, Germany, 20246
    • Local Institution - 300
  • Hamburg, Germany, 22763
    • Local Institution - 302
  • Heidelberg, Germany, 69120
    • Local Institution - 305
  • Lübeck, Germany, 23562
    • Local Institution - 304
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Local Institution - 308
• Greece
  • Athens, Greece, 115 28
    • Local Institution - 571
  • Thessaloniki, Greece, 54007
    • Local Institution - 572
  • Thessaloniki, Greece, 57010
    • Local Institution - 570
  • Achaea
    • Pátrai, Achaea, Greece, 26054
      • Local Institution - 573
  • Achaia
    • Pátrai, Achaia, Greece, 264 43
      • Local Institution - 574
• India
  • Puducherry, India, 605006
    • Local Institution - 931
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500084
      • Local Institution - 932
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Local Institution - 930
  • Kerala
    • Ernākulam, Kerala, India, 682041
      • Local Institution - 934
  • Maharashtra
    • Mumbai, Maharashtra, India, 400036
      • Local Institution - 933
  • West Bengal
    • Kolkata, West Bengal, India, 700014
      • Local Institution - 935
• Ireland
  • Cork, Ireland, T12 DFK4
    • Local Institution - 752
  • Dublin, Ireland, D09 V2N0
    • Local Institution - 750
  • Galway, Ireland, H91 YR71
    • Local Institution - 751
• Israel
  • Haifa, Israel, 35254
    • Local Institution - 872
  • Jerusalem, Israel, 91120
    • Local Institution - 871
  • Tel Aviv, Israel, 64239
    • Local Institution - 870
  • Tel Litwinsky, Israel, 52621
    • Local Institution - 873
  • Northern District
    • Afula, Northern District, Israel, 18101
      • Local Institution - 874
• Italy
  • Bologna, Italy, 40138
    • Local Institution - 400
  • Catania, Italy, 95124
    • Local Institution - 408
  • Genova, Italy, 16132
    • Local Institution - 414
  • Milan, Italy, 20122
    • Local Institution - 404
  • Novara, Italy, 28100
    • Local Institution - 410
  • Pavia, Italy, 27100
    • Local Institution - 412
  • Pisa, Italy, 56126
    • Local Institution - 402
  • Reggio Calabria, Italy, 89100
    • Local Institution - 405
  • Roma, Italy, 00189
    • Local Institution - 401
  • San Giovanni Rotondo FG, Italy, 71013
    • Local Institution - 403
  • Udine, Italy, 33100
    • Local Institution - 406
  • Lazio
    • Rome, Lazio, Italy, 00193
      • Local Institution - 415
• Japan
  • Aomori, Japan, 030-8553
    • Local Institution - 912
  • Chiba, Japan, 260-8717
    • Local Institution - 916
  • Fukuoka, Japan, 810-8563
    • Local Institution - 911
  • Kamogawa, Japan, 296-8602
    • Local Institution - 903
  • Kyoto, Japan, 602-8566
    • Local Institution - 902
  • Nagoya, Japan, 464-8681
    • Local Institution - 910
  • Nagoya, Japan, 467-8602
    • Local Institution - 901
  • Okayama, Japan, 701-1192
    • Local Institution - 905
  • Osaka, Japan, 545-8585
    • Local Institution - 907
  • Sapporo, Japan, 003-0006
    • Local Institution - 913
  • Sendai, Japan, 980-8574
    • Local Institution - 914
  • Shibuya-ku, Japan, 150-8935
    • Local Institution - 906
  • Shinagawa-ku, Tokyo, Japan, 141-8625
    • Local Institution - 909
  • Toyohashi, Japan, 441-8570
    • Local Institution - 904
  • Ōsaka-sayama, Japan, 589-8511
    • Local Institution - 908
  • Ehime
    • Matsuyama, Ehime, Japan, 790-8524
      • Local Institution - 900
  • Ibaraki
    • Higashi-Ibaraki-gun, Ibaraki, Japan, 311-3193
      • Local Institution - 917
  • Tochigi
    • Shimotsuga, Tochigi, Japan, 321-0293
      • Local Institution - 919
  • Tokyo
    • Nerima-ku, Tokyo, Japan, 179-0072
      • Local Institution - 920
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Local Institution - 918
  • Yamanashi
    • Chuo-shi, Yamanashi, Japan, 4093898
      • Local Institution - 915
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Local Institution - 183
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Local Institution - 354
  • The Hague, Netherlands, 2545 CH
    • Local Institution - 352
  • South Holland
    • Dordrecht, South Holland, Netherlands, 3318 AT
      • Local Institution - 351
• Norway
  • Bergen, Norway, N-5053
    • Local Institution - 202
  • Oslo, Norway, 0450
    • Local Institution - 200
  • Trondheim, Norway, 7030
    • Local Institution - 201
• Poland
  • Krakow, Poland, 30-688
    • Local Institution - 633
  • Nowy Sącz, Poland, 33-300
    • Local Institution - 635
  • Poznan, Poland, 60-569
    • Local Institution - 634
  • Warsaw, Poland, 02-781
    • Local Institution - 630
  • Wałbrzych, Poland, 58-309
    • Local Institution - 636
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-276
      • Local Institution - 631
• Portugal
  • Coimbra, Portugal, 4200-072
    • Local Institution - 545
  • Lisbon, Portugal, 1099-023
    • Local Institution - 543
  • Lisbon, Portugal, 1400-038
    • Local Institution - 544
  • Porto, Portugal, 4200-072
    • Local Institution - 540
  • Porto, Portugal, 4200-319
    • Local Institution - 541
• South Korea
  • Daegu, South Korea, 700-721
    • Local Institution - 974
  • Gyeonggi-do, South Korea, 410-769
    • Local Institution - 973
  • Hwasun-gun, South Korea, 519-809
    • Local Institution - 975
  • Seoul, South Korea, 06351
    • Local Institution - 971
  • Seoul, South Korea, 06591
    • Local Institution - 976
  • Seoul, South Korea, 120-752
    • Local Institution - 972
  • Seoul, South Korea, 3080
    • Local Institution - 970
  • Seoul, South Korea, 5505
    • Local Institution - 977
• Spain
  • Barcelona, Spain, 08025
    • Local Institution - 505
  • Barcelona, Spain, 08035
    • Local Institution - 502
  • Barcelona, Spain, 08916
    • Local Institution - 511
  • Cáceres, Spain, 10005
    • Local Institution - 501
  • Córdoba, Spain, 14001
    • Local Institution - 509
  • Madrid, Spain, 28006
    • Local Institution - 510
  • Madrid, Spain, 28027
    • Local Institution - 516
  • Madrid, Spain, 28034
    • Local Institution - 504
  • Madrid, Spain, 28040
    • Local Institution - 513
  • Murcia, Spain, 30120
    • Local Institution - 508
  • Málaga, Spain, 29010
    • Local Institution - 503
  • Oviedo, Spain, 33011
    • Local Institution - 506
  • Salamanca, Spain, 37007
    • Local Institution - 515
  • Santiago de Compostela, Spain, 15706
    • Local Institution - 500
  • Valencia, Spain, 46026
    • Local Institution - 512
  • Zaragoza, Spain, 50009
    • Local Institution - 507
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Local Institution - 514
• Sweden
  • Borås, Sweden, 50182
    • Local Institution - 272
  • Helsingborg, Sweden, 25437
    • Local Institution - 271
• Switzerland
  • Chur, Switzerland, 7000
    • Local Institution - 851
  • Sankt Gallen, Switzerland, CH-9007
    • Local Institution - 850
• Taiwan
  • Niao-Sung Hsiang Kaohsiung County, Taiwan, 83301
    • Local Institution - 955
  • Taichung, Taiwan, 407219
    • Local Institution - 954
  • Taichung, Taiwan, 40447
    • Local Institution - 952
  • Tainan, Taiana, Taiwan, 704
    • Local Institution - 951
  • Taipei, Taiwan, 11217
    • Local Institution - 950
  • Taipei, Zhongzheng Dist., Taiwan, 10002
    • Local Institution - 956
  • Taoyuan, Taiwan, 33305
    • Local Institution - 953
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Local Institution - 770
  • Gaziantep, Turkey (Türkiye), 27310
    • Local Institution - 772
  • Kayseri, Turkey (Türkiye), 38140
    • Local Institution - 774
  • Ankara
    • Kavaklıdere, Ankara, Turkey (Türkiye), 06680
      • Local Institution - 778
    • Yenimahalle, Ankara, Turkey (Türkiye), 6200
      • Local Institution - 776
  • Istanbul
    • Pendik, Istanbul, Turkey (Türkiye), 34899
      • Local Institution - 777
  • Kurupelit
    • Samsun, Kurupelit, Turkey (Türkiye), 55239
      • Local Institution - 773
  • İzmir
    • Balçova, İzmir, Turkey (Türkiye), 35340
      • Local Institution - 771
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Local Institution - 775
• United Kingdom
  • Belfast Northern Ireland, United Kingdom, BT9 7AD
    • Local Institution - 705
  • Birmingham, United Kingdom, B15 2TH
    • Local Institution - 700
  • Canterbury Kent, United Kingdom, CT1 3NG
    • Local Institution - 707
  • Lancashire Blackpool, United Kingdom, FY3 8NR
    • Local Institution - 704
  • London, United Kingdom, NW1 2BU
    • Local Institution - 701
  • London, United Kingdom, SE1 9RT
    • Local Institution - 709
  • Oxford, United Kingdom, OX3 7LE
    • Local Institution - 706
  • Portsmouth, United Kingdom, PO6 3LY
    • Local Institution - 711
  • Sutton, United Kingdom, SM2 5PT
    • Local Institution - 713
  • Wolverhampton, United Kingdom, WV10 0QP
    • Local Institution - 708
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Local Institution - 702
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Local Institution - 035
  • California
    • Cerritos, California, United States, 90703-2679
      • Local Institution - 641
    • Fountain Valley, California, United States, 92708
      • Local Institution - 681
    • Los Angeles, California, United States, 90033
      • Local Institution - 047
    • Newport, California, United States, 92663
      • Local Institution - 684
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Local Institution - 033
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Local Institution - 029
    • Ocala, Florida, United States, 34471-6950
      • Local Institution - 693
    • St. Petersburg, Florida, United States, 33705
      • Local Institution - 028
    • Tamarac, Florida, United States, 33321-2909
      • Local Institution - 045
    • West Palm Beach, Florida, United States, 33401
      • Local Institution - 034
    • Weston, Florida, United States, 33331-3609
      • Local Institution - 685
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 018
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007-3363
      • Local Institution - 640
  • Indiana
    • Dyer, Indiana, United States, 46311-1596
      • Local Institution - 697
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Local Institution - 040
  • Louisiana
    • Alexandria, Louisiana, United States, 71301-3841
      • Local Institution - 041
    • Baton Rouge, Louisiana, United States, 70808-4300
      • Local Institution - 682
    • Baton Rouge, Louisiana, United States, 70809-3675
      • Local Institution - 027
  • Maryland
    • Baltimore, Maryland, United States, 21204-6826
      • Local Institution - 698
    • Bethesda, Maryland, United States, 20817
      • Local Institution - 014
    • Columbia, Maryland, United States, 21044-3128
      • Local Institution - 688
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 010
    • Worcester, Massachusetts, United States, 01655
      • Local Institution - 009
  • Minnesota
    • Burnsville, Minnesota, United States, 55337-6749
      • Local Institution - 645
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Local Institution - 031
  • Montana
    • Billings, Montana, United States, 59102-6746
      • Local Institution - 046
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Local Institution - 015
  • New York
    • New York, New York, United States, 10016
      • Local Institution - 691
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Local Institution - 039
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Local Institution - 038
    • Cleveland, Ohio, United States, 44109
      • Local Institution - 037
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 008
    • Columbus, Ohio, United States, 43214
      • Local Institution - 036
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146-6236
      • Local Institution - 680
  • Oregon
    • Portland, Oregon, United States, 97239
      • Local Institution - 043
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Local Institution - 030
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 021
  • Texas
    • Austin, Texas, United States, 78705-1165
      • Local Institution - 687
    • Houston, Texas, United States, 77025
      • Local Institution - 695
  • Virginia
    • Newport News, Virginia, United States, 23606-3069
      • Local Institution - 642
    • Roanoke, Virginia, United States, 24014-2419
      • Local Institution - 643
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Local Institution - 025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1; Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.	Drug: Dexamethasone; Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle; Drug: Iberdomide; Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Iberdomide; Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Iberdomide; Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Daratumumab; 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; Other Names: DARZALEX FASPRO; Drug: Dexamethasone; Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8; Drug: Daratumumab; Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.; Other Names: DARZALEX FASPRO
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2	Drug: Dexamethasone; Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle; Drug: Iberdomide; Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Iberdomide; Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Iberdomide; Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Daratumumab; 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; Other Names: DARZALEX FASPRO; Drug: Dexamethasone; Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8; Drug: Daratumumab; Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.; Other Names: DARZALEX FASPRO
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3	Drug: Dexamethasone; Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle; Drug: Iberdomide; Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Iberdomide; Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Iberdomide; Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle; Other Names: CC-220; BMS-986382; Drug: Daratumumab; 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; Other Names: DARZALEX FASPRO; Drug: Dexamethasone; Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8; Drug: Daratumumab; Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.; Other Names: DARZALEX FASPRO
Active Comparator: Daratumumab in combination with dexamethasone and bortezomib; Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone	Drug: Dexamethasone; Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle; Drug: Bortezomib; Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.; Drug: Daratumumab; 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; Other Names: DARZALEX FASPRO; Drug: Dexamethasone; Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8; Drug: Daratumumab; Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.; Other Names: DARZALEX FASPRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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).	Up to approximately 5 years
Overall Response Rate (ORR)	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.	Up to approximately 5 years
Time to response (TTR)	Time from randomization to the first documentation of response (PR or better).	Up to approximately 5 years
Duration of Response (DoR)	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.	Up to approximately 5 years
Time to Progression (TTP)	The time from randomization to the first documented disease progression.	Up to approximately 5 years
Time to Next Treatment (TTNT)	Time from randomization to the start of the next antimyeloma treatment.	Up to approximately 5 years
Progression-free Survival 2 (PFS2)	Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.	Up to approximately 5 years
Safety	Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.	Up to approximately 5 years
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	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.	Up to approximately 5 years
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	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.	Up to approximately 5 years
Recommended iberdomide dose for Stage 2		Up to approximately 1 year
Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))		Up to approximately 1 year
Maximum plasma concentration (Cmax)		Up to approximately 1 year
Time to maximum plasma concentration (Tmax)		Up to approximately 1 year
Sustainability of Minimal Residual Disease (MRD) negativity	To evaluate the sustainability of minimal residual disease (MRD) negativity.	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): November 16, 2027
• Study Completion (Estimated): June 25, 2032

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Daratumumab; Dexamethasone; Iberdomide; CC-220; Darzalex Faspro; Bortezomib; Velcade; MM; RRMM; CELMoD; Cereblon Modulators
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Dexamethasone; daratumumab; iberdomide
• Other Study ID Numbers: CC-220-MM-002; U1111-1260-2872 (Other Identifier: UTN Number); 2020-000431-49 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No