A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)

March 27, 2024 updated by: Celgene

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

Study Overview

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • 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

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

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

    • Buenos Aires
      • Florencio Varela, Buenos Aires, Argentina, 1888
        • Local Institution - 0222
        • Contact:
          • Site 0222
      • La Plata, Buenos Aires, Argentina, 1900
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • Pilar, Buenos Aires, Argentina, 1629
        • Local Institution - 0262
        • Contact:
          • Site 0262
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1118AAT
        • Local Institution - 0002
        • Contact:
          • Site 0002
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Local Institution - 0260
        • Contact:
          • Site 0260
      • Macquarie University, New South Wales, Australia, 2109
        • Local Institution - 0246
        • Contact:
          • Site 0246
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0022
        • Contact:
          • Site 0022
    • Queensland
      • Brisbane, Queensland, Australia, 4120
        • Local Institution - 0397
        • Contact:
          • Site 0397
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0019
        • Contact:
          • Site 0019
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0018
        • Contact:
          • Site 0018
      • Melbourne, Victoria, Australia, 3065
        • Local Institution - 0003
        • Contact:
          • Site 0003
      • Salzburg, Austria, 5020
        • Local Institution - 0334
        • Contact:
          • Site 0334
      • Wien, Austria, 1090
        • Local Institution - 0332
        • Contact:
          • Site 0332
    • Niederösterreich
      • St. Polten, Niederösterreich, Austria, 3100
        • Local Institution - 0333
        • Contact:
          • Site 0333
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Local Institution - 0337
        • Contact:
          • Site 0337
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Local Institution - 0284
        • Contact:
          • Site 0284
    • Liège
      • Verviers, Liège, Belgium, 4800
        • Local Institution - 0280
        • Contact:
          • Site 0280
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Local Institution - 0279
        • Contact:
          • Site 0279
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Local Institution - 0286
        • Contact:
          • Site 0286
      • Rio de Janeiro, Brazil, 22250-905
        • Local Institution - 0291
        • Contact:
          • Site 0291
      • São Paulo, Brazil, 05652-900
        • Local Institution - 0211
        • Contact:
          • Site 0211
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-022
        • Local Institution - 0274
        • Contact:
          • Site 0274
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59025050
        • Local Institution - 0351
        • Contact:
          • Site 0351
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01509-010
        • Local Institution - 0369
        • Contact:
          • Site 0369
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution - 0417
        • Contact:
          • Site 0417
      • Edmonton, Alberta, Canada, T6G1Z2
        • Local Institution - 0423
        • Contact:
          • Site 0423
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Local Institution - 0402
        • Contact:
          • Site 0402
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0395
        • Contact:
          • Site 0395
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Montréal, Quebec, Canada, H2X 1P1
        • Local Institution - 0098
        • Contact:
          • Site 0098
    • Metropolitana DE Santiago
      • Santiago, Metropolitana DE Santiago, Chile, 7580206
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Región Metropolitana De Santiago
      • Santiago, Región Metropolitana De Santiago, Chile, 7500921
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Santiago, Región Metropolitana De Santiago, Chile, 7650568
        • Local Institution - 0029
        • Contact:
          • Site 0029
      • Santiago, Región Metropolitana De Santiago, Chile, 7620002
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Qingdao, China, 266011
        • Local Institution - 0367
        • Contact:
          • Site 0367
    • Beijing
      • Beijing, Beijing, China
        • Local Institution - 0413
        • Contact:
          • Site 0413
      • Beijing, Beijing, China, 100020
        • Local Institution - 0230
        • Contact:
          • Site 0230
      • Beijing, Beijing, China, 100034
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Changping, Beijing, China, 102200
        • Local Institution - 0366
        • Contact:
          • Site 0366
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Local Institution - 0057
        • Contact:
          • Site 0057
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Local Institution - 0080
        • Contact:
          • Site 0080
      • Guangzhou, Guangdong, China, 510060
        • Local Institution - 0066
        • Contact:
          • Site 0066
      • Guangzhou, Guangdong, China, 510515
        • Local Institution - 0226
        • Contact:
          • Site 0226
      • Shenzhen, Guangdong, China, 518036
        • Local Institution - 0368
        • Contact:
          • Site 0368
    • Hebei
      • Baoding, Hebei, China, 071030
        • Local Institution - 0365
        • Contact:
          • Site 0365
      • Shijiazhuang, Hebei, China, 050051
        • Local Institution - 0082
        • Contact:
          • Site 0082
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0041
        • Contact:
          • Site 0041
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Hunan
      • Changsha, Hunan, China, 410011
        • Local Institution - 0062
        • Contact:
          • Site 0062
      • Changsha, Hunan, China, 410013
        • Local Institution - 0053
        • Contact:
          • Site 0053
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0055
        • Contact:
          • Site 0055
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0067
        • Contact:
          • Site 0067
      • Xuzhou, Jiangsu, China, 221006
        • Local Institution - 0377
        • Contact:
          • Site 0377
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Shaanxi
      • Xi'An, Shaanxi, China, 710004
        • Local Institution - 0072
        • Contact:
          • Site 0072
    • Shandong
      • Jinan, Shandong, China, 250014
        • Local Institution - 0077
        • Contact:
          • Site 0077
      • Jinan, Shandong, China, 250117
        • Local Institution - 0083
        • Contact:
          • Site 0083
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0273
        • Contact:
          • Site 0273
      • Shanghai, Shanghai, China, 200081
        • Local Institution - 0421
        • Contact:
          • Site 0421
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Local Institution - 0245
        • Contact:
          • Site 0245
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Local Institution - 0056
        • Contact:
          • Site 0056
      • Tianjin, Tianjin, China, 300308
        • Local Institution - 0422
        • Contact:
          • Site 0422
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0070
        • Contact:
          • Site 0070
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0203
        • Contact:
          • Site 0203
      • Praha 2, Czechia, 12808
        • Local Institution - 0012
        • Contact:
          • Site 0012
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Local Institution - 0013
        • Contact:
          • Site 0013
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 779 00
        • Local Institution - 0247
        • Contact:
          • Site 0247
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31100
        • Local Institution - 0118
        • Contact:
          • Site 0118
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Local Institution - 0225
        • Contact:
          • Site 0225
    • Lorraine
      • Vandoeuvre lès Nancy, Lorraine, France, 54511
        • Local Institution - 0224
        • Contact:
          • Site 0224
    • Nord
      • Lille, Nord, France, 59000
        • Local Institution - 0084
        • Contact:
          • Site 0084
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • Local Institution - 0085
        • Contact:
          • Site 0085
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Local Institution - 0192
        • Contact:
          • Site 0192
      • Hamburg, Germany, 22763
        • Local Institution - 0339
        • Contact:
          • Site 0339
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Local Institution - 0331
        • Contact:
          • Site 0331
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Local Institution - 0330
        • Contact:
          • Site 0330
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Local Institution - 0335
        • Contact:
          • Site 0335
      • Leipzig, Sachsen, Germany, 04103
        • Local Institution - 0329
        • Contact:
          • Site 0329
    • Attikí
      • Athens, Attikí, Greece, 115 28
        • Local Institution - 0004
        • Contact:
          • Site 0004
      • Chaidari, Attikí, Greece, 12462
        • Local Institution - 0136
        • Contact:
          • Site 0136
      • Budapest, Hungary, 1088
        • Local Institution - 0104
        • Contact:
          • Site 0104
      • Budapest, Hungary, 1097
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Local Institution - 0103
        • Contact:
          • Site 0103
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • Local Institution - 0108
        • Contact:
          • Site 0108
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530040
        • Local Institution - 0370
        • Contact:
          • Site 0370
    • Haryana
      • Gurugram, Haryana, India, 122011
        • Local Institution - 0362
        • Contact:
          • Site 0362
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Local Institution - 0403
        • Contact:
          • Site 0403
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Local Institution - 0399
        • Contact:
          • Site 0399
    • West Bengal
      • Kolkata, West Bengal, India, 700094
        • Local Institution - 0398
        • Contact:
          • Site 0398
      • Cork, Ireland, T12 E8YV
        • Local Institution - 0281
        • Contact:
          • Site 0281
      • Dublin, Ireland, D04 N2E0
        • Local Institution - 0371
        • Contact:
          • Site 0371
      • Dublin, Ireland, D08 E9P6
        • Local Institution - 0285
        • Contact:
          • Site 0285
      • Limerick, Ireland, V94 F858
        • Local Institution - 0269
        • Contact:
          • Site 0269
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Local Institution - 0096
        • Contact:
          • Site 0096
    • Milano
      • Legnano, Milano, Italy, 20025
        • Local Institution - 0294
        • Contact:
          • Site 0294
      • Milan, Milano, Italy, 20162
        • Local Institution - 0265
        • Contact:
          • Site 0265
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Local Institution - 0410
        • Contact:
          • Site 0410
      • Chiba, Japan, 260-8677
        • Local Institution - 0383
        • Contact:
          • Site 0383
      • Kumamoto, Japan, 860-8556
        • Local Institution - 0391
        • Contact:
          • Site 0391
      • Kyoto, Japan, 602-8566
        • Local Institution - 0389
        • Contact:
          • Site 0389
      • Okayama, Japan, 701-1192
        • Local Institution - 0388
        • Contact:
          • Site 0388
      • Tokyo, Japan, 150-8935
        • Local Institution - 0384
        • Contact:
          • Site 0384
    • Aichi
      • Anjo, Aichi, Japan, 446-8602
        • Local Institution - 0409
        • Contact:
          • Site 0409
      • Nagoya, Aichi, Japan, 467-8602
        • Local Institution - 0387
        • Contact:
          • Site 0387
    • Chiba
      • Kamogawa, Chiba, Japan, 296-0041
        • Local Institution - 0407
        • Contact:
          • Site 0407
      • Kashiwa, Chiba, Japan, 277-8577
        • Local Institution - 0385
        • Contact:
          • Site 0385
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Local Institution - 0386
        • Contact:
          • Site 0386
    • Osaka
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Local Institution - 0390
        • Contact:
          • Site 0390
    • Tochigi
      • Shimotsuga, Tochigi, Japan, 321-0293
        • Local Institution - 0381
        • Contact:
          • Site 0381
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Local Institution - 0382
        • Contact:
          • Site 0382
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Local Institution - 0240
        • Contact:
          • Site 0240
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
        • Local Institution - 0221
        • Contact:
          • Site 0221
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Local Institution - 0036
        • Contact:
          • Site 0036
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Local Institution - 0239
        • Contact:
          • Site 0239
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Local Institution - 0034
        • Contact:
          • Site 0034
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Oslo, Norway, 0450
        • Local Institution - 0193
        • Contact:
          • Site 0193
    • Akershus
      • Løenskog, Akershus, Norway, 1474
        • Local Institution - 0137
        • Contact:
          • Site 0137
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Local Institution - 0115
        • Contact:
          • Site 0115
      • Lisboa, Portugal, 1500-650
        • Local Institution - 0255
        • Contact:
          • Site 0255
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1099-023
        • Local Institution - 0242
        • Contact:
          • Site 0242
      • Lisbon, Lisboa, Portugal, 1649-035
        • Local Institution - 0415
        • Contact:
          • Site 0415
      • Brasov, Romania, 500052
        • Local Institution - 0171
        • Contact:
          • Site 0171
      • București, Romania, 050098
        • Local Institution - 0414
        • Contact:
          • Site 0414
    • București
      • Bucuresti, București, Romania, 022328
        • Local Institution - 0169
        • Contact:
          • Site 0169
      • Jerez de la Frontera, Spain, 11407
        • Local Institution - 0202
        • Contact:
          • Site 0202
      • Salamanca, Spain, 37007
        • Local Institution - 0006
        • Contact:
          • Site 0006
      • Santiago de Compostela, Spain, 15706
        • Local Institution - 0007
        • Contact:
          • Site 0007
      • València, Spain, 46026
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Murcia, Región De
      • El Palmar, Murcia, Murcia, Región De, Spain, 30120
        • Local Institution - 0234
        • Contact:
          • Site 0234
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Local Institution - 0008
        • Contact:
          • Site 0008
    • Västra Götalands Län [se-14]
      • Borås, Västra Götalands Län [se-14], Sweden, 501 82
        • Local Institution - 0114
        • Contact:
          • Site 0114
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Local Institution - 0111
        • Contact:
          • Site 0111
      • Zürich, Switzerland, 8063
        • Local Institution - 0338
        • Contact:
          • Site 0338
    • Berne
      • Bern, Berne, Switzerland, 3010
        • Local Institution - 0336
        • Contact:
          • Site 0336
    • Sankt Gallen
      • st.Gallen, Sankt Gallen, Switzerland, 9007
        • Local Institution - 0411
        • Contact:
          • Site 0411
      • Ankara, Turkey, 06200
        • Local Institution - 0375
        • Contact:
          • Site 0375
      • Kayseri, Turkey
        • Local Institution - 0187
        • Contact:
          • Site 0187
      • İzmir, Turkey, 35100
        • Local Institution - 0188
        • Contact:
          • Site 0188
    • İstanbul
      • Stanbul, İstanbul, Turkey, 34214
        • Local Institution - 0325
        • Contact:
          • Site 0325
      • Cardiff, United Kingdom, CF14 4XW
        • Local Institution - 0350
        • Contact:
          • Site 0350
      • Derby, United Kingdom, DE22 3NE
        • Local Institution - 0344
        • Contact:
          • Site 0344
      • Manchester, United Kingdom, M20 4BX
        • Local Institution - 0343
        • Contact:
          • Site 0343
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 0YD
        • Local Institution - 0349
        • Contact:
          • Site 0349
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • Local Institution - 0342
        • Contact:
          • Site 0342
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Local Institution - 0151
        • Contact:
          • Site 0151
    • California
      • Los Angeles, California, United States, 90095
        • Local Institution - 0088
        • Contact:
          • Site 0088
      • Stanford, California, United States, 94305
        • Local Institution - 0358
        • Contact:
          • Site 0358
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0355
        • Contact:
          • Site 0355
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution - 0434
        • Contact:
          • Site 0434
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Local Institution - 0323
        • Contact:
          • Site 0323
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Local Institution - 0324
        • Contact:
          • Site 0324
    • Montana
      • Billings, Montana, United States, 59102
        • Local Institution - 0435
        • Contact:
          • Site 0435
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0157
        • Contact:
          • Site 0157
      • Summit, New Jersey, United States, 07901
        • Local Institution - 0359
        • Contact:
          • Site 0359
    • New York
      • Lake Success, New York, United States, 11042
        • Local Institution - 0430
        • Contact:
          • Site 0430
      • New York, New York, United States, 10065
        • Local Institution - 0396
        • Contact:
          • Site 0396
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Local Institution - 0306
        • Contact:
          • Site 0306
      • Cleveland, Ohio, United States, 44109
        • Local Institution - 0199
        • Contact:
          • Site 0199
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 0437
        • Contact:
          • Site 0437
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Local Institution - 0352
        • Contact:
          • Site 0352
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Local Institution - 0420
        • Contact:
          • Site 0420
    • Texas
      • Dallas, Texas, United States, 75390-88520
        • Local Institution - 0168
        • Contact:
          • Site 0168
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0405
        • Contact:
          • Site 0405

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
  • Documented diagnosis of multiple myeloma (MM), and must:.

    i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.

ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).

iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.

iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.

  • Must have measurable disease (as determined by central laboratory).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.

Exclusion Criteria

  • Active, uncontrolled, or suspected infection.
  • Known current, or history of, central nervous system involvement of multiple myeloma.
  • History or presence of clinically relevant CNS pathology.
  • Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
  • Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
  • 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
Intervention / Treatment
Experimental: Arm A: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
Active Comparator: Arm B: Standard of Care Regimens
Specified dose on specified days
Specified dose on specified days
Other Names:
  • CC-4047
  • BMS-986379
  • POMALYST®
  • IMNOVID®
Specified dose on specified days
Other Names:
  • KYPROLIS®
Specified dose on specified days
Other Names:
  • BMS-901608
  • Empliciti®
Specified dose on specified days
Other Names:
  • DARZALEX
  • DARZALEX®
  • FASPRO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to response (TTR)
Time Frame: Up to 5 years
Up to 5 years
Duration of response (DOR)
Time Frame: Up to 5 years
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 5 years
Up to 5 years
Incidence of serious adverse events (SAEs)
Time Frame: Up to 5 years
Up to 5 years
Overall response (OR)
Time Frame: Up to 5 years
Up to 5 years
Complete response (CR) or better
Time Frame: Up to 5 years
Up to 5 years
Very good partial response (VGPR) or better
Time Frame: Up to 5 years
Up to 5 years
Time to progression (TTP)
Time Frame: Up to 5 years
Up to 5 years
Time to next treatment (TTNT)
Time Frame: Up to 5 years
Up to 5 years
Progression-free survival 2 (PFS2)
Time Frame: Up to 5 years
Up to 5 years
Restricted mean DOR (RMDOR)
Time Frame: Up to 5 years
Up to 5 years
Minimal residual disease (MRD) negativity rate
Time Frame: Up to 5 years
Up to 5 years
Incidence of adverse events (AEs)
Time Frame: Up to 5 years
Up to 5 years
Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)
Time Frame: Up to 5 years
Up to 5 years
Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

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

Sponsor

Investigators

  • 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.

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 (Estimated)

March 29, 2024

Primary Completion (Estimated)

November 16, 2025

Study Completion (Estimated)

September 21, 2030

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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/disclosurecommitment.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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