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)

May 30, 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

Status

Withdrawn

Conditions

Multiple Myeloma

Intervention / Treatment

Study Type

Interventional

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 Locations

Argentina
- Buenos Aires
  - Florencio Varela, Buenos Aires, Argentina, 1888
    - Local Institution - 0222
  - La Plata, Buenos Aires, Argentina, 1900
    - Local Institution - 0001
  - Pilar, Buenos Aires, Argentina, 1629
    - Local Institution - 0262
- Ciudad Autónoma De Buenos Aires
  - Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1118AAT
    - Local Institution - 0002
Australia
- New South Wales
  - Liverpool, New South Wales, Australia, 2170
    - Local Institution - 0260
  - Macquarie University, New South Wales, Australia, 2109
    - Local Institution - 0246
  - Waratah, New South Wales, Australia, 2298
    - Local Institution - 0022
- Queensland
  - Brisbane, Queensland, Australia, 4120
    - Local Institution - 0397
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Local Institution - 0021
  - Clayton, Victoria, Australia, 3168
    - Local Institution - 0019
  - Melbourne, Victoria, Australia, 3004
    - Local Institution - 0018
  - Melbourne, Victoria, Australia, 3065
    - Local Institution - 0003
Austria
- - Salzburg, Austria, 5020
    - Local Institution - 0334
  - Wien, Austria, 1090
    - Local Institution - 0332
- Niederösterreich
  - St. Polten, Niederösterreich, Austria, 3100
    - Local Institution - 0333
- Tirol
  - Innsbruck, Tirol, Austria, 6020
    - Local Institution - 0337
Belgium
- Antwerpen
  - Brasschaat, Antwerpen, Belgium, 2930
    - Local Institution - 0284
- Liège
  - Verviers, Liège, Belgium, 4800
    - Local Institution - 0280
- Namur
  - Yvoir, Namur, Belgium, 5530
    - Local Institution - 0279
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Local Institution - 0286
Brazil
- - Rio de Janeiro, Brazil, 22250-905
    - Local Institution - 0291
  - São Paulo, Brazil, 05652-900
    - Local Institution - 0211
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30110-022
    - Local Institution - 0274
- Rio Grande Do Norte
  - Natal, Rio Grande Do Norte, Brazil, 59025050
    - Local Institution - 0351
- São Paulo
  - Sao Paulo, São Paulo, Brazil, 01509-010
    - Local Institution - 0369
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Local Institution - 0417
  - Edmonton, Alberta, Canada, T6G1Z2
    - Local Institution - 0423
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - Local Institution - 0402
  - Toronto, Ontario, Canada, M5G 2M9
    - Local Institution - 0395
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - Local Institution - 0031
  - Montréal, Quebec, Canada, H2X 1P1
    - Local Institution - 0098
Chile
- Metropolitana DE Santiago
  - Santiago, Metropolitana DE Santiago, Chile, 7580206
    - Local Institution - 0027
- Región Metropolitana De Santiago
  - Santiago, Región Metropolitana De Santiago, Chile, 7500921
    - Local Institution - 0030
  - Santiago, Región Metropolitana De Santiago, Chile, 7650568
    - Local Institution - 0029
  - Santiago, Región Metropolitana De Santiago, Chile, 7620002
    - Local Institution - 0026
China
- - Qingdao, China, 266011
    - Local Institution - 0367
- Beijing
  - Beijing, Beijing, China
    - Local Institution - 0413
  - Beijing, Beijing, China, 100020
    - Local Institution - 0230
  - Beijing, Beijing, China, 100034
    - Local Institution - 0040
  - Changping, Beijing, China, 102200
    - Local Institution - 0366
- Chongqing
  - Chongqing, Chongqing, China, 400016
    - Local Institution - 0057
- Guangdong
  - Guangzhou, Guangdong, China, 510120
    - Local Institution - 0080
  - Guangzhou, Guangdong, China, 510060
    - Local Institution - 0066
  - Guangzhou, Guangdong, China, 510515
    - Local Institution - 0226
  - Shenzhen, Guangdong, China, 518036
    - Local Institution - 0368
- Hebei
  - Baoding, Hebei, China, 071030
    - Local Institution - 0365
  - Shijiazhuang, Hebei, China, 050051
    - Local Institution - 0082
- Henan
  - Zhengzhou, Henan, China, 450008
    - Local Institution - 0041
- Hubei
  - Wuhan, Hubei, China, 430030
    - Local Institution - 0075
- Hunan
  - Changsha, Hunan, China, 410011
    - Local Institution - 0062
  - Changsha, Hunan, China, 410013
    - Local Institution - 0053
- Jiangsu
  - Nanjing, Jiangsu, China, 210000
    - Local Institution - 0055
  - Suzhou, Jiangsu, China, 215006
    - Local Institution - 0067
  - Xuzhou, Jiangsu, China, 221006
    - Local Institution - 0377
- Liaoning
  - Shenyang, Liaoning, China, 110004
    - Local Institution - 0044
- Shaanxi
  - Xi'An, Shaanxi, China, 710004
    - Local Institution - 0072
- Shandong
  - Jinan, Shandong, China, 250014
    - Local Institution - 0077
  - Jinan, Shandong, China, 250117
    - Local Institution - 0083
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Local Institution - 0273
  - Shanghai, Shanghai, China, 200081
    - Local Institution - 0421
- Shanxi
  - Taiyuan, Shanxi, China, 030000
    - Local Institution - 0245
- Tianjin
  - Tianjin, Tianjin, China, 300052
    - Local Institution - 0056
  - Tianjin, Tianjin, China, 300308
    - Local Institution - 0422
- Zhejiang
  - Hangzhou, Zhejiang, China, 310003
    - Local Institution - 0070
  - Hangzhou, Zhejiang, China, 310003
    - Local Institution - 0203
Czechia
- - Praha 2, Czechia, 12808
    - Local Institution - 0012
- Brno-město
  - Brno, Brno-město, Czechia, 625 00
    - Local Institution - 0013
- Olomoucký Kraj
  - Olomouc, Olomoucký Kraj, Czechia, 779 00
    - Local Institution - 0247
France
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31100
    - Local Institution - 0118
- Languedoc-Roussillon
  - Montpellier, Languedoc-Roussillon, France, 34295
    - Local Institution - 0225
- Lorraine
  - Vandoeuvre lès Nancy, Lorraine, France, 54511
    - Local Institution - 0224
- Nord
  - Lille, Nord, France, 59000
    - Local Institution - 0084
- Pays-de-la-Loire
  - Nantes, Pays-de-la-Loire, France, 44000
    - Local Institution - 0085
- Rhône
  - Pierre-Bénite, Rhône, France, 69310
    - Local Institution - 0192
Germany
- - Hamburg, Germany, 22763
    - Local Institution - 0339
- Baden-Württemberg
  - Heidelberg, Baden-Württemberg, Germany, 69120
    - Local Institution - 0331
  - Tübingen, Baden-Württemberg, Germany, 72076
    - Local Institution - 0330
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - Local Institution - 0335
  - Leipzig, Sachsen, Germany, 04103
    - Local Institution - 0329
Greece
- Attikí
  - Athens, Attikí, Greece, 115 28
    - Local Institution - 0004
  - Chaidari, Attikí, Greece, 12462
    - Local Institution - 0136
Hungary
- - Budapest, Hungary, 1088
    - Local Institution - 0104
  - Budapest, Hungary, 1097
    - Local Institution - 0105
- Szabolcs-Szatmár-Bereg
  - Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
    - Local Institution - 0103
- Vas
  - Szombathely, Vas, Hungary, 9700
    - Local Institution - 0108
India
- Andhra Pradesh
  - Visakhapatnam, Andhra Pradesh, India, 530040
    - Local Institution - 0370
- Haryana
  - Gurugram, Haryana, India, 122011
    - Local Institution - 0362
- Karnataka
  - Bangalore, Karnataka, India, 560092
    - Local Institution - 0403
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226014
    - Local Institution - 0399
- West Bengal
  - Kolkata, West Bengal, India, 700094
    - Local Institution - 0398
Ireland
- - Cork, Ireland, T12 E8YV
    - Local Institution - 0281
  - Dublin, Ireland, D04 N2E0
    - Local Institution - 0371
  - Dublin, Ireland, D08 E9P6
    - Local Institution - 0285
  - Limerick, Ireland, V94 F858
    - Local Institution - 0269
Italy
- Emilia-Romagna
  - Meldola, Emilia-Romagna, Italy, 47014
    - Local Institution - 0096
- Milano
  - Legnano, Milano, Italy, 20025
    - Local Institution - 0294
  - Milan, Milano, Italy, 20162
    - Local Institution - 0265
- Sicilia
  - Palermo, Sicilia, Italy, 90127
    - Local Institution - 0410
Japan
- - Aomori, Japan, 030-8553
    - Local Institution - 0419
  - Chiba, Japan, 260-8677
    - Local Institution - 0383
  - Kumamoto, Japan, 860-8556
    - Local Institution - 0391
  - Kyoto, Japan, 602-8566
    - Local Institution - 0389
  - Okayama, Japan, 701-1192
    - Local Institution - 0388
  - Tokyo, Japan, 150-8935
    - Local Institution - 0384
- Aichi
  - Anjo, Aichi, Japan, 446-8602
    - Local Institution - 0409
  - Nagoya, Aichi, Japan, 467-8602
    - Local Institution - 0387
- Chiba
  - Kamogawa, Chiba, Japan, 296-0041
    - Local Institution - 0407
  - Kashiwa, Chiba, Japan, 277-8577
    - Local Institution - 0385
- Kanagawa
  - Isehara, Kanagawa, Japan, 259-1193
    - Local Institution - 0386
- Osaka
  - Osaka-sayama, Osaka, Japan, 589-8511
    - Local Institution - 0390
- Tochigi
  - Shimotsuga, Tochigi, Japan, 321-0293
    - Local Institution - 0381
- Tokyo
  - Koto, Tokyo, Japan, 135-8550
    - Local Institution - 0382
Korea, Republic of
- Kyǒnggi-do
  - Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
    - Local Institution - 0240
- Pusan-Kwangyǒkshi
  - Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
    - Local Institution - 0221
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
    - Local Institution - 0036
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
    - Local Institution - 0239
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
    - Local Institution - 0034
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
    - Local Institution - 0035
Norway
- - Oslo, Norway, 0450
    - Local Institution - 0193
- Akershus
  - Løenskog, Akershus, Norway, 1474
    - Local Institution - 0137
- Hordaland
  - Bergen, Hordaland, Norway, 5021
    - Local Institution - 0115
Portugal
- - Lisboa, Portugal, 1500-650
    - Local Institution - 0255
- Lisboa
  - Lisbon, Lisboa, Portugal, 1099-023
    - Local Institution - 0242
  - Lisbon, Lisboa, Portugal, 1649-035
    - Local Institution - 0415
Romania
- - Brasov, Romania, 500052
    - Local Institution - 0171
  - București, Romania, 050098
    - Local Institution - 0414
- București
  - Bucuresti, București, Romania, 022328
    - Local Institution - 0169
Spain
- - Jerez de la Frontera, Spain, 11407
    - Local Institution - 0202
  - Salamanca, Spain, 37007
    - Local Institution - 0006
  - Santiago de Compostela, Spain, 15706
    - Local Institution - 0007
  - València, Spain, 46026
    - Local Institution - 0009
- Barcelona [Barcelona]
  - Badalona, Barcelona [Barcelona], Spain, 08916
    - Local Institution - 0011
- Murcia, Región De
  - El Palmar, Murcia, Murcia, Región De, Spain, 30120
    - Local Institution - 0234
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Local Institution - 0008
Sweden
- Västra Götalands Län [se-14]
  - Borås, Västra Götalands Län [se-14], Sweden, 501 82
    - Local Institution - 0114
  - Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
    - Local Institution - 0111
Switzerland
- - Zürich, Switzerland, 8063
    - Local Institution - 0338
- Berne
  - Bern, Berne, Switzerland, 3010
    - Local Institution - 0336
- Sankt Gallen
  - st.Gallen, Sankt Gallen, Switzerland, 9007
    - Local Institution - 0411
Turkey
- - Ankara, Turkey, 06200
    - Local Institution - 0375
  - Kayseri, Turkey
    - Local Institution - 0187
  - İzmir, Turkey, 35100
    - Local Institution - 0188
- İstanbul
  - Stanbul, İstanbul, Turkey, 34214
    - Local Institution - 0325
United Kingdom
- - Cardiff, United Kingdom, CF14 4XW
    - Local Institution - 0350
  - Derby, United Kingdom, DE22 3NE
    - Local Institution - 0344
  - Manchester, United Kingdom, M20 4BX
    - Local Institution - 0343
- Hampshire
  - Southampton, Hampshire, United Kingdom, SO16 0YD
    - Local Institution - 0349
- London, City Of
  - London, London, City Of, United Kingdom, NW1 2PG
    - Local Institution - 0342
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Local Institution - 0151
- California
  - Los Angeles, California, United States, 90095
    - Local Institution - 0088
  - Stanford, California, United States, 94305
    - Local Institution - 0358
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Local Institution - 0355
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Local Institution - 0434
- Kansas
  - Wichita, Kansas, United States, 67214
    - Local Institution - 0433
- Kentucky
  - Saint Matthews, Kentucky, United States, 40207
    - Local Institution - 0439
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Local Institution - 0323
- Maryland
  - Baltimore, Maryland, United States, 21218
    - Local Institution - 0324
  - Bethesda, Maryland, United States, 20889
    - Local Institution - 0441
- Montana
  - Billings, Montana, United States, 59102
    - Local Institution - 0435
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Local Institution - 0157
  - Summit, New Jersey, United States, 07901
    - Local Institution - 0359
- New York
  - Lake Success, New York, United States, 11042
    - Local Institution - 0430
  - New York, New York, United States, 10065
    - Local Institution - 0396
- Ohio
  - Cincinnati, Ohio, United States, 45220
    - Local Institution - 0306
  - Cleveland, Ohio, United States, 44109
    - Local Institution - 0199
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15224
    - Local Institution - 0437
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Local Institution - 0352
- South Dakota
  - Watertown, South Dakota, United States, 57201
    - Local Institution - 0420
- Texas
  - Dallas, Texas, United States, 75390-88520
    - Local Institution - 0168
- Washington
  - Seattle, Washington, United States, 98109
    - Local Institution - 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

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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Alnuctamab	Drug: Alnuctamab Specified dose on specified days Other Names: BMS-986349 CC-93269
Active Comparator: Arm B: Standard of Care Regimens	Drug: Dexamethasone Specified dose on specified days Drug: Pomalidomide Specified dose on specified days Other Names: CC-4047 BMS-986379 POMALYST® IMNOVID® Drug: Carfilzomib Specified dose on specified days Other Names: KYPROLIS® Drug: Elotuzumab Specified dose on specified days Other Names: BMS-901608 Empliciti® Drug: Daratumumab Specified dose on specified days Other Names: DARZALEX DARZALEX® FASPRO®