A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT ID: NCT06232707
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2024-05-03
2030-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Alnuctamab
Alnuctamab
Specified dose on specified days
Arm B: Standard of Care Regimens
Pomalidomide
Specified dose on specified days
Daratumumab
Specified dose on specified days
Elotuzumab
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Interventions
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Alnuctamab
Specified dose on specified days
Pomalidomide
Specified dose on specified days
Daratumumab
Specified dose on specified days
Elotuzumab
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0151
Birmingham, Alabama, United States
Local Institution - 0088
Los Angeles, California, United States
Local Institution - 0358
Stanford, California, United States
Local Institution - 0355
New Haven, Connecticut, United States
Local Institution - 0434
Washington D.C., District of Columbia, United States
Local Institution - 0433
Wichita, Kansas, United States
Local Institution - 0439
Saint Matthews, Kentucky, United States
Local Institution - 0323
New Orleans, Louisiana, United States
Local Institution - 0324
Baltimore, Maryland, United States
Local Institution - 0441
Bethesda, Maryland, United States
Local Institution - 0435
Billings, Montana, United States
Local Institution - 0157
Hackensack, New Jersey, United States
Local Institution - 0359
Summit, New Jersey, United States
Local Institution - 0430
Lake Success, New York, United States
Local Institution - 0396
New York, New York, United States
Local Institution - 0306
Cincinnati, Ohio, United States
Local Institution - 0199
Cleveland, Ohio, United States
Local Institution - 0437
Pittsburgh, Pennsylvania, United States
Local Institution - 0352
Providence, Rhode Island, United States
Local Institution - 0420
Watertown, South Dakota, United States
Local Institution - 0168
Dallas, Texas, United States
Local Institution - 0405
Seattle, Washington, United States
Local Institution - 0001
La Plata, Buenos Aires, Argentina
Local Institution - 0262
Pilar, Buenos Aires, Argentina
Local Institution - 0222
San Juan Bautista, Buenos Aires, Argentina
Local Institution - 0002
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0260
Liverpool, New South Wales, Australia
Local Institution - 0246
Macquarie University, New South Wales, Australia
Local Institution - 0022
Waratah, New South Wales, Australia
Local Institution - 0397
Brisbane, Queensland, Australia
Local Institution - 0021
Box Hill, Victoria, Australia
Local Institution - 0019
Clayton, Victoria, Australia
Local Institution - 0018
Melbourne, Victoria, Australia
Local Institution - 0003
Melbourne, Victoria, Australia
Local Institution - 0333
Sankt Pölten, Lower Austria, Austria
Local Institution - 0337
Innsbruck, Tyrol, Austria
Local Institution - 0334
Salzburg, , Austria
Local Institution - 0332
Vienna, , Austria
Local Institution - 0284
Brasschaat, Antwerpen, Belgium
Local Institution - 0280
Verviers, Liège, Belgium
Local Institution - 0279
Yvoir, Namur, Belgium
Local Institution - 0286
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0274
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0351
Natal, Rio Grande do Norte, Brazil
Local Institution - 0369
São Paulo, São Paulo, Brazil
Local Institution - 0291
Rio de Janeiro, , Brazil
Local Institution - 0211
São Paulo, , Brazil
Local Institution - 0417
Calgary, Alberta, Canada
Local Institution - 0423
Edmonton, Alberta, Canada
Local Institution - 0402
London, Ontario, Canada
Local Institution - 0395
Toronto, Ontario, Canada
Local Institution - 0031
Montreal, Quebec, Canada
Local Institution - 0098
Montreal, Quebec, Canada
Local Institution - 0027
Santiago, Metropolitana de Santiago, Chile
Local Institution - 0030
Santiago, Santiago Metropolitan, Chile
Local Institution - 0026
Santiago, Santiago Metropolitan, Chile
Local Institution - 0029
Santiago, Santiago Metropolitan, Chile
Local Institution - 0413
Beijing, Beijing Municipality, China
Local Institution - 0230
Beijing, Beijing Municipality, China
Local Institution - 0040
Beijing, Beijing Municipality, China
Local Institution - 0366
Changping, Beijing Municipality, China
Local Institution - 0057
Chongqing, Chongqing Municipality, China
Local Institution - 0066
Guangzhou, Guangdong, China
Local Institution - 0080
Guangzhou, Guangdong, China
Local Institution - 0226
Guangzhou, Guangdong, China
Local Institution - 0368
Shenzhen, Guangdong, China
Local Institution - 0365
Baoding, Hebei, China
Local Institution - 0082
Shijiazhuang, Hebei, China
Local Institution - 0041
Zhengzhou, Henan, China
Local Institution - 0075
Wuhan, Hubei, China
Local Institution - 0062
Changsha, Hunan, China
Local Institution - 0053
Changsha, Hunan, China
Local Institution - 0055
Nanjing, Jiangsu, China
Local Institution - 0067
Suzhou, Jiangsu, China
Local Institution - 0377
Xuzhou, Jiangsu, China
Local Institution - 0044
Shenyang, Liaoning, China
Local Institution - 0072
Xi'an, Shaanxi, China
Local Institution - 0077
Jinan, Shandong, China
Local Institution - 0083
Jinan, Shandong, China
Local Institution - 0273
Shanghai, Shanghai Municipality, China
Local Institution - 0421
Shanghai, Shanghai Municipality, China
Local Institution - 0245
Taiyuan, Shanxi, China
Local Institution - 0056
Tianjin, Tianjin Municipality, China
Local Institution - 0422
Tianjin, Tianjin Municipality, China
Local Institution - 0070
Hangzhou, Zhejiang, China
Local Institution - 0203
Hangzhou, Zhejiang, China
Local Institution - 0367
Qingdao, , China
Local Institution - 0013
Brno, Brno-město, Czechia
Local Institution - 0247
Olomouc, Olomoucký kraj, Czechia
Local Institution - 0012
Prague, , Czechia
Local Institution - 0118
Toulouse, Haute-Garonne, France
Local Institution - 0225
Montpellier, Languedoc-Roussillon, France
Local Institution - 0224
Vandœuvre-lès-Nancy, Lorraine, France
Local Institution - 0084
Lille, Nord, France
Local Institution - 0085
Nantes, Pays de la Loire Region, France
Local Institution - 0192
Pierre-Bénite, Rhône, France
Local Institution - 0331
Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0330
Tübingen, Baden-Wurttemberg, Germany
Local Institution - 0335
Dresden, Saxony, Germany
Local Institution - 0329
Leipzig, Saxony, Germany
Local Institution - 0339
Hamburg, , Germany
Local Institution - 0004
Athens, Attikí, Greece
Local Institution - 0136
Chaïdári, Attikí, Greece
Local Institution - 0103
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Local Institution - 0108
Szombathely, Vas County, Hungary
Local Institution - 0104
Budapest, , Hungary
Local Institution - 0105
Budapest, , Hungary
Local Institution - 0370
Visakhapatnam, Andhra Pradesh, India
Local Institution - 0362
Gurugram, Haryana, India
Local Institution - 0403
Bangalore, Karnataka, India
Local Institution - 0399
Lucknow, Uttar Pradesh, India
Local Institution - 0398
Kolkata, West Bengal, India
Local Institution - 0281
Cork, , Ireland
Local Institution - 0371
Dublin, , Ireland
Local Institution - 0285
Dublin, , Ireland
Local Institution - 0269
Limerick, , Ireland
Local Institution - 0096
Meldola, Emilia-Romagna, Italy
Local Institution - 0294
Legnano, Milano, Italy
Local Institution - 0265
Milan, Milano, Italy
Local Institution - 0410
Palermo, Sicily, Italy
Local Institution - 0409
Anjo, Aichi-ken, Japan
Local Institution - 0387
Nagoya, Aichi-ken, Japan
Local Institution - 0407
Kamogawa, Chiba, Japan
Local Institution - 0385
Kashiwa, Chiba, Japan
Local Institution - 0386
Isehara, Kanagawa, Japan
Local Institution - 0390
Ōsaka-sayama, Osaka, Japan
Local Institution - 0381
Shimotsuga, Tochigi, Japan
Local Institution - 0382
Koto, Tokyo, Japan
Local Institution - 0419
Aomori, , Japan
Local Institution - 0383
Chiba, , Japan
Local Institution - 0391
Kumamoto, , Japan
Local Institution - 0389
Kyoto, , Japan
Local Institution - 0388
Okayama, , Japan
Local Institution - 0384
Tokyo, , Japan
Local Institution - 0137
Løenskog, Akershus, Norway
Local Institution - 0115
Bergen, Hordaland, Norway
Local Institution - 0193
Oslo, , Norway
Local Institution - 0242
Lisbon, Lisbon District, Portugal
Local Institution - 0415
Lisbon, Lisbon District, Portugal
Local Institution - 0255
Lisbon, , Portugal
Local Institution - 0169
Bucharest, București, Romania
Local Institution - 0171
Brasov, , Romania
Local Institution - 0414
Bucharest, , Romania
Local Institution - 0240
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0221
Busan, Pusan-Kwangyǒkshi, South Korea
Local Institution - 0036
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0239
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0034
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0035
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0011
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0234
El Palmar, Murcia, Murcia, Región de, Spain
Local Institution - 0008
Pamplona, Navarre, Spain
Local Institution - 0202
Jerez de la Frontera, , Spain
Local Institution - 0006
Salamanca, , Spain
Local Institution - 0007
Santiago de Compostela, , Spain
Local Institution - 0009
Valencia, , Spain
Local Institution - 0114
Borås, Västra Götalands Län [se-14], Sweden
Local Institution - 0111
Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0336
Bern, Canton of Bern, Switzerland
Local Institution - 0411
Sankt Gallen, Canton of St. Gallen, Switzerland
Local Institution - 0338
Zurich, , Switzerland
Local Institution - 0325
Stanbul, Istanbul, Turkey (Türkiye)
Local Institution - 0375
Ankara, , Turkey (Türkiye)
Local Institution - 0188
Izmir, , Turkey (Türkiye)
Local Institution - 0187
Kayseri, , Turkey (Türkiye)
Local Institution - 0349
Southampton, Hampshire, United Kingdom
Local Institution - 0342
London, London, City of, United Kingdom
Local Institution - 0350
Cardiff, , United Kingdom
Local Institution - 0344
Derby, , United Kingdom
Local Institution - 0343
Manchester, , United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-509472-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1281-8227
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA058-1019
Identifier Type: -
Identifier Source: org_study_id
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