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

September 16, 2026 updated by: Bristol-Myers Squibb

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000JHGQ
        • Local Institution - 0182
    • B
      • Pilar, B, Argentina, B1629AHJ
        • Local Institution - 0267
    • Buenos Aires F.D.
      • Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina, C1199ABB
        • Local Institution - 0183
      • Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina, C1430EFA
        • Local Institution - 0227
  • Australia
      • Waratah, Australia, 2298
        • Local Institution - 0244
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0088
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution - 0220
      • Clayton, Victoria, Australia, 3800
        • Local Institution - 0078
  • Austria
      • Linz, Austria, 4020
        • Local Institution - 0058
      • Sankt Pölten, Austria, 3100
        • Local Institution - 0034
      • Vienna, Austria, 1140
        • Hanusch-Krankenhaus
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien - Universitaetsklinik fuer Augenheilkunde und Optometrie
  • Belgium
      • Kortrijk, Belgium, 8500
        • Local Institution - 0048
    • WHT
      • Charleroi, WHT, Belgium, 6060
        • Local Institution - 0035
  • Brazil
      • Barretos, Brazil, 14784-400
        • Local Institution - 0190
      • Porto Alegre, Brazil, 90880-480
        • Local Institution - 0083
      • Rio de Janeiro, Brazil, 21941-913
        • Local Institution - 0096
      • Salvador, Brazil, 40110-150
        • Local Institution - 0098
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brazil, 24020-096
        • Local Institution - 0214
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
        • Local Institution - 0082
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Local Institution - 0081
      • São Paulo, São Paulo, Brazil, 04537-080
        • Local Institution - 0277
      • São Paulo, São Paulo, Brazil, 05403-000
        • Local Institution - 0194
      • São Paulo, São Paulo, Brazil, 08270-070
        • Local Institution - 0241
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0270
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0208
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0307
      • Québec, Quebec, Canada
        • Local Institution - 0210
  • Chile
      • Santiago, Chile, 7500691
        • Local Institution - 0186
      • Temuco, Chile, 4800827
        • Local Institution - 0258
      • Vitacura, Chile, 7650567
        • Local Institution - 0099
  • China
      • Beijing, China, 100020
        • Local Institution - 0100
      • Beijing, China, 100044
        • Local Institution - 0216
      • Changsha, China, 400011
        • Local Institution - 0234
      • Fuzhou, China, 350001
        • Local Institution - 0273
      • Guangzhou, China, 511363
        • Local Institution - 0079
      • Jinan, China, 250021
        • Local Institution - 0212
      • Nanjing, China, 210029
        • Local Institution - 0231
      • Qingdao, China, 266071
        • Local Institution - 0077
      • Shanghai, China, 200025
        • Local Institution - 0223
      • Suzhou, China, 215006
        • Local Institution - 0305
      • Wenzhou, China, 325000
        • Local Institution - 0087
      • Wuhan, China, 430022
        • Local Institution - 0248
      • Wuhan, China, 430030
        • Local Institution - 0084
    • AH
      • Hefei, AH, China, 230001
        • Local Institution - 0196
    • BJ
      • Beijing, BJ, China, 100038
        • Local Institution - 0326
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100071
        • Local Institution - 0229
    • CQ
      • Chongqing, CQ, China, 400030
        • Local Institution - 0321
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Local Institution - 0242
    • GD
      • Guangzhou, GD, China, 510515
        • Local Institution - 0304
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 0261
      • Shenzhen, Guangdong, China, 518028
        • Local Institution - 0256
    • HN
      • Changsha, HN, China, 410013
        • Local Institution - 0262
      • Changsha, HN, China, 410013
        • Local Institution - 0282
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Local Institution - 0246
    • JL
      • Changchun, JL, China, 130021
        • Local Institution - 0091
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Local Institution - 0266
      • Xuzhou, Jiangsu, China, 221000
        • Local Institution - 0239
    • Jiangxi
      • Nanchang, Jiangxi, China, 330200
        • Local Institution - 0263
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Local Institution - 0094
    • SD
      • Jinan, SD, China, 250012
        • Local Institution - 0240
    • SH
      • Shanghai, SH, China, 200434
        • Local Institution - 0319
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Local Institution - 0265
      • Xi'an, Shaanxi, China, 710061
        • Local Institution - 0318
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Local Institution - 0249
    • ZJ
      • Hangzhou, ZJ, China, 310003
        • Local Institution - 0243
      • Ningbo, ZJ, China, 315010
        • Local Institution - 0320
  • Colombia
      • Bogotá, Colombia, 110111
        • Local Institution - 0217
      • Bogotá, Colombia, 110131
        • Local Institution - 0211
      • Floridablanca, Colombia, 681004
        • Local Institution - 0101
      • Medellín, Colombia, 050034
        • Local Institution - 0179
      • Valledupar, Colombia, 200001
        • Local Institution - 0093
    • COR
      • Montería, COR, Colombia, 230002
        • Local Institution - 0302
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0036
      • Olomouc, Czechia, 779 00
        • Local Institution - 0206
      • Prague, Czechia, 100 34
        • Local Institution - 0215
      • Prague, Czechia, 128 08
        • Local Institution - 0069
  • Denmark
      • Odense, Denmark, 5000
        • Local Institution - 0028
  • Finland
      • Helsinki, Finland, 00290
        • Local Institution - 0276
      • Kuopio, Finland, 70211
        • Local Institution - 0201
  • France
      • Amiens, France, 80000
        • Local Institution - 0030
      • Caen, France, 14033
        • Local Institution - 0055
      • Créteil, France, 94000
        • Local Institution - 0050
      • La Roche-sur-Yon, France, 85000
        • Local Institution - 0236
      • Lille, France, 59037
        • Local Institution - 0054
      • Limoges, France, 87042
        • Local Institution - 0221
      • Nantes, France, 44093
        • Local Institution - 0272
      • Paris, France, 75012
        • Local Institution - 0219
      • Paris, France, 75013
        • Local Institution - 0228
      • Toulouse, France, 31059
        • Local Institution - 0051
  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Universitatsklinikum Freiburg
      • Hamburg, Germany, 20246
        • Local Institution - 0297
      • Hamm, Germany, 59073
        • Local Institution - 0026
      • Jena, Germany, 07747
        • Local Institution - 0038
      • Tübingen, Germany, 72076
        • Local Institution - 0040
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitätsklinikum Ulm
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Local Institution - 0324
      • Bayreuth, Bavaria, Germany, 95445
        • Klinikum Bayreuth GmbH
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen - Medizinische Klinik 5
      • Munich, Bavaria, Germany, 81377
        • LMU Klinikum der Universitaet Muenchen - Campus Grosshadern - Transplantation
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • Carl-Thiem-Klinikum Cottbus GmbH
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763
        • Local Institution - 0315
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Local Institution - 0316
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12203
        • Local Institution - 0037
  • Greece
      • Athens, Greece, 115 28
        • Local Institution - 0233
      • Larissa, Greece, 411 10
        • Local Institution - 0290
      • Thessaloniki, Greece, 546 39
        • Local Institution - 0063
    • B
      • Thessaloniki, B, Greece, 570 10
        • Local Institution - 0209
    • G
      • Rio, G, Greece, 265 04
        • Local Institution - 0097
    • I
      • Athens, I, Greece, 106 76
        • Local Institution - 0185
  • Hong Kong
    • HK
      • Hong Kong, HK, Hong Kong, 000000
        • Local Institution - 0250
  • Hungary
    • HB
      • Debrecen, HB, Hungary, 4032
        • Local Institution - 0062
  • India
    • Chandigarh
      • Chandigarh, Chandigarh, India, 160012
        • Local Institution - 0128
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Local Institution - 0110
    • Kerala
      • Kochi, Kerala, India, 68202
        • Local Institution - 0109
    • Maharashtra
      • Kolhāpur, Maharashtra, India, 416005
        • Local Institution - 0200
      • Nagpur, Maharashtra, India, 440030
        • Local Institution - 0152
      • Pune, Maharashtra, India, 411 004
        • Local Institution - 0123
      • Pune, Maharashtra, India, 411004
        • Local Institution - 0142
    • Odisha
      • Bhubaneswar, Odisha, India, 751007
        • Local Institution - 0124
    • West Bengal
      • Kolkata, West Bengal, India, 700160
        • Local Institution - 0125
  • Israel
      • Ashdod, Israel, 7747629
        • Local Institution - 0057
      • Beer Ya'Aqov, Israel, 70300
        • Local Institution - 0137
      • Hadera, Israel, 38100
        • Local Institution - 0027
      • Haifa, Israel, 3109601
        • Local Institution - 0047
      • Jerusalem, Israel, 91031
        • Local Institution - 0075
      • Jerusalem, Israel, 9112001
        • Local Institution - 0060
      • Petah Tikva, Israel, 49100
        • Local Institution - 0108
      • Ramat Gan, Israel, 52621
        • Local Institution - 0131
  • Italy
      • Naples, Italy, 80131
        • Local Institution - 0074
      • Pavia, Italy, 27100
        • Local Institution - 0278
      • Rome, Italy, 00161
        • Policlinico Umberto I
    • CT
      • Catania, CT, Italy, 95123
        • Local Institution - 0053
    • FI
      • Florence, FI, Italy, 50134
        • Local Institution - 0306
    • GE
      • Genova, GE, Italy, 16132
        • Local Institution - 0115
    • MI
      • Milan, MI, Italy, 20122
        • Local Institution - 0188
      • Milan, MI, Italy, 20162
        • Local Institution - 0071
    • PI
      • Pisa, PI, Italy, 56127
        • Local Institution - 0139
    • RM
      • Roma, RM, Italy, 00168
        • Local Institution - 0046
    • TO
      • Torino, TO, Italy, 10126
        • Local Institution - 0140
  • Japan
      • Chiba, Japan, 260-8677
        • Local Institution - 0141
      • Gifu, Japan, 500-8513
        • Local Institution - 0118
      • Hiroshima, Japan, 730-8619
        • Local Institution - 0112
      • Isehara-shi, Japan, 259-1193
        • Local Institution - 0199
      • Itabashi-Ku, Japan, 173-8610
        • Local Institution - 0330
      • Kagoshima, Japan, 890-8520
        • Local Institution - 0111
      • Kanazawa, Japan, 920-8641
        • Local Institution - 0144
      • Kōtoku, Japan, 135-8550
        • Local Institution - 0122
      • Maebashi, Japan, 371-8511
        • Local Institution - 0121
      • Minatoku, Japan, 105-8471
        • Local Institution - 0150
      • Nagasaki, Japan, 852-8511
        • Local Institution - 0104
      • Nagoya, Japan, 467-8602
        • Local Institution - 0143
      • Nerima-Ku, Japan, 179-0072
        • Local Institution - 0329
      • Saitama-Shi, Japan, 330-0834
        • Local Institution - 0148
      • Sakaishi, Japan, 590-0197
        • Local Institution - 0268
      • Sapporo, Japan, 003-0006
        • Local Institution - 0105
      • Sendai, Japan, 983-8520
        • Local Institution - 0132
      • Shibuya-ku, Japan, 150-8935
        • Local Institution - 0116
    • Gunma
      • Shibukawa-shi, Gunma, Japan, 3770280
        • Local Institution - 0106
    • Kanagawa
      • Kamakura-Shi, Kanagawa, Japan, 2478533
        • Local Institution - 0197
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Local Institution - 0198
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Local Institution - 0130
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0283
    • State of Mexico
      • Toluca, State of Mexico, Mexico, 50090
        • Local Institution - 0146
  • Netherlands
      • Dordrecht, Netherlands, 3300 AK
        • Local Institution - 0070
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Local Institution - 0129
  • Poland
      • Bydgoszcz, Poland, 85-048
        • Local Institution - 0327
      • Gdansk, Poland, 80-214
        • Local Institution - 0195
      • Gliwice, Poland, 44-102
        • Local Institution - 0252
      • Katowice, Poland, 40-519
        • Local Institution - 0039
      • Lublin, Poland, 20-134
        • Local Institution - 0044
      • Warsaw, Poland, 02-781
        • Local Institution - 0119
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Local Institution - 0149
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-510
        • Local Institution - 0059
  • Portugal
      • Braga, Portugal, 4710-243
        • Local Institution - 0023
      • Coimbra, Portugal, 3000-075
        • Local Institution - 0151
      • Porto, Portugal, 4200-072
        • Instituto Português Oncologia do Porto Francisco Gentil, EPE
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0072
    • B
      • Bucharest, B, Romania, 022328
        • Local Institution - 0117
    • Dolj
      • Craiova, Dolj, Romania, 200143
        • Local Institution - 0043
    • IS
      • Iași, IS, Romania, 700483
        • Local Institution - 0224
    • Jud. Cluj
      • Cluj-Napoca, Jud. Cluj, Romania, 400015
        • Local Institution - 0064
  • Singapore
      • Singapore, Singapore, 119074
        • Local Institution - 0138
      • Singapore, Singapore, 169608
        • Local Institution - 0187
  • South Korea
      • Busan, South Korea, 49241
        • Local Institution - 0145
      • Goyang-si, South Korea, 410-769
        • Local Institution - 0113
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Local Institution - 0293
      • Seoul, South Korea, 03722
        • Local Institution - 0295
      • Seoul, South Korea, 06351
        • Local Institution - 0114
      • Ulsan, South Korea, 44033
        • Local Institution - 0225
  • Spain
      • Badalona, Spain, 08916
        • Local Institution - 0232
      • Madrid, Spain, 28022
        • Local Institution - 0317
      • Palma de Mallorca, Spain, 07120
        • Local Institution - 0164
      • Pamplona, Spain, 31008
        • Local Institution - 0163
    • B
      • Barcelona, B, Spain, 08036
        • Hospital Clinic de Barcelona
    • CC
      • Cáceres, CC, Spain, 10003
        • Local Institution - 0169
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Local Institution - 0172
    • MU
      • Murcia, MU, Spain, 30120
        • Local Institution - 0155
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Local Institution - 0166
    • VC
      • Valencia, VC, Spain, 46026
        • Local Institution - 0174
  • Sweden
      • Borås, Sweden, 501 82
        • Local Institution - 0230
      • Uddevalla, Sweden, 451 51
        • Local Institution - 0291
  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Local Institution - 0175
      • Kaohsiung City, Taiwan, 83301
        • Local Institution - 0153
      • New Taipei City, Taiwan, 220
        • Local Institution - 0159
      • Tainan, Taiwan, 704
        • Local Institution - 0165
      • Taipei, Taiwan, 10002
        • Local Institution - 0292
      • Taoyuan, Taiwan, 333
        • Local Institution - 0289
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Local Institution - 0167
      • Edirne, Turkey (Türkiye), 22030
        • Local Institution - 0052
      • Istanbul, Turkey (Türkiye), 34381
        • Local Institution - 0309
      • Izmir, Turkey (Türkiye), 35100
        • Local Institution - 0158
      • Izmir, Turkey (Türkiye), 35575
        • Local Institution - 0073
      • Kayseri, Turkey (Türkiye), 38039
        • Local Institution - 0024
      • Yenimahalle, Turkey (Türkiye), 06200
        • Local Institution - 0032
      • Çankaya, Turkey (Türkiye), 06680
        • Local Institution - 0287
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Local Institution - 0160
      • London, United Kingdom, W1G 6AF
        • Local Institution - 0025
      • Oxford, United Kingdom, OX4 6LB
        • Local Institution - 0029
    • ABD
      • Aberdeen, ABD, United Kingdom, AB25 2ZN
        • Local Institution - 0173
    • Berkshire
      • Windsor, Berkshire, United Kingdom, SL4 3HD
        • Local Institution - 0161
    • DBY
      • Derby, DBY, United Kingdom, DE22 3NE
        • Local Institution - 0156
    • DOR
      • Bournemouth, DOR, United Kingdom, BH7 7DW
        • Local Institution - 0162
    • HAM
      • Portsmouth, HAM, United Kingdom, PO6 3LY
        • Local Institution - 0284
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Local Institution - 0154
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012-5405
        • Local Institution - 0202
    • Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Local Institution - 0007
      • Tampa, Florida, United States, 33606
        • Local Institution - 0308
      • Tampa, Florida, United States, 33612-9416
        • Local Institution - 0192
      • Weston, Florida, United States, 33331-3609
        • Local Institution - 0003
    • Georgia
      • Athens, Georgia, United States, 30607-1465
        • Local Institution - 0019
      • Atlanta, Georgia, United States, 30322-1013
        • Local Institution - 0018
      • Augusta, Georgia, United States, 30912
        • Local Institution - 0021
    • Illinois
      • Chicago, Illinois, United States, 60637-1426
        • Local Institution - 0237
    • Kansas
      • Westwood, Kansas, United States, 66205-2003
        • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
    • Maryland
      • Clinton, Maryland, United States, 20735-4230
        • Local Institution - 0205
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Local Institution - 0279
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • Local Institution - 0001
      • Detroit, Michigan, United States, 48202-2610
        • Local Institution - 0257
      • Grand Rapids, Michigan, United States, 49503
        • Local Institution - 0296
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0303
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Local Institution - 0207
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Local Institution - 0191
    • New York
      • Brooklyn, New York, United States, 11220-3313
        • Local Institution - 0328
      • Mineola, New York, United States, 11501
        • Local Institution - 0288
      • New York, New York, United States, 10016-6402
        • Local Institution - 0180
      • New York, New York, United States, 10032-3729
        • Local Institution - 0020
      • Westbury, New York, United States, 11590-5119
        • Local Institution - 0274
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0331
      • Charlotte, North Carolina, United States, 28803-2493
        • Local Institution - 0005
      • Durham, North Carolina, United States, 27705-3976
        • Local Institution - 0281
      • Winston-Salem, North Carolina, United States, 27103
        • Local Institution - 0286
      • Winston-Salem, North Carolina, United States, 27157
        • Local Institution - 0322
    • Ohio
      • Cincinnati, Ohio, United States, 45236-2725
        • Local Institution - 0238
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0002
      • Cleveland, Ohio, United States, 44111
        • Local Institution - 0299
      • Kansas, Ohio, United States, 64132
        • Local Institution - 0017
      • Mayfield Heights, Ohio, United States, 44124
        • Local Institution - 0301
      • Toledo, Ohio, United States, 43623
        • Local Institution - 0013
      • Wooster, Ohio, United States, 44691
        • Local Institution - 0300
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0203
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2433
        • Local Institution - 0011
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 0012
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0253
    • Tennessee
      • Germantown, Tennessee, United States, 38138-1762
        • Local Institution - 0294
      • Nashville, Tennessee, United States, 37203-1625
        • Local Institution - 0004
    • Texas
      • Dallas, Texas, United States, 75246
        • Local Institution - 0193
      • Dallas, Texas, United States, 75390-0001
        • Local Institution - 0009
      • Houston, Texas, United States, 77030
        • Local Institution - 0006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A1: Iberdomide Dose 1
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A2: Iberdomide Dose 2
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A3: Iberdomide Dose 3
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Active Comparator: Arm B: Lenalidomide
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 6 years
Up to 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
Time Frame: Up to 6 years
Up to 6 years
Overall Survival
Time Frame: Up to 12 years
Up to 12 years
Recommended iberdomide dose for Stage 2
Time Frame: Up to 1 year
Up to 1 year
Area under the iberdomide plasma concentration-time curve from time zero to tau
Time Frame: Up to 1 year
Up to 1 year
Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
Time Frame: Up to 1 year
Up to 1 year
Maximum iberdomide concentration (Cmax)
Time Frame: Up to 1 year
Up to 1 year
Time to maximum iberdomide plasma concentration (Tmax)
Time Frame: Up to 1 year
Up to 1 year
Number of participants with adverse events (AEs)
Time Frame: Up to 6 years
Up to 6 years
Progression-free survival on next line of treatment (PFS2)
Time Frame: Up to 6 years
Up to 6 years
Achieving MRD negativity in participants with CR or better at any time after the date of randomization
Time Frame: Up to 6 years
Up to 6 years
Conversion from MRD positive to MRD negative in participants with CR or better
Time Frame: Up to 6 years
Up to 6 years
Time to progression (TTP)
Time Frame: Up to 6 years
Up to 6 years
Time to next treatment (TTNT)
Time Frame: Up to 6 years
Up to 6 years
Best response achieved prior to progressive disease (PD)
Time Frame: Up to 6 years
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)
Time Frame: Up to 6 years
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)
Time Frame: Up to 6 years
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 1 year apart, without any examination showing MRD positive status in between assessments
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM048-022
  • U1111-1280-9492 (Other Identifier: WHO)
  • 2022-501515-14-00 (Other Identifier: EU CTR)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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