A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06232707
- Lead Sponsor
- Celgene
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Alnuctamab Alnuctamab - Arm B: Standard of Care Regimens Daratumumab - Arm B: Standard of Care Regimens Pomalidomide - Arm B: Standard of Care Regimens Elotuzumab - Arm B: Standard of Care Regimens Carfilzomib - Arm B: Standard of Care Regimens Dexamethasone -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to 5 years
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs) Up to 5 years Overall Survival (OS) Up to 5 years Time to response (TTR) Up to 5 years Time to progression (TTP) Up to 5 years Minimal residual disease (MRD) negativity rate Up to 5 years Complete response (CR) or better Up to 5 years Overall response (OR) Up to 5 years Very good partial response (VGPR) or better Up to 5 years Progression-free survival 2 (PFS2) 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) Up to 5 years Duration of response (DOR) Up to 5 years Restricted mean DOR (RMDOR) Up to 5 years Time to next treatment (TTNT) Up to 5 years Incidence of adverse events (AEs) Up to 5 years Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20) Up to 5 years
Trial Locations
- Locations (170)
Local Institution - 0088
🇺🇸Los Angeles, California, United States
Local Institution - 0324
🇺🇸Baltimore, Maryland, United States
Local Institution - 0022
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0434
🇺🇸Washington, District of Columbia, United States
Local Institution - 0323
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0352
🇺🇸Providence, Rhode Island, United States
Local Institution - 0420
🇺🇸Watertown, South Dakota, United States
Local Institution - 0435
🇺🇸Billings, Montana, United States
Local Institution - 0246
🇦🇺Macquarie University, New South Wales, Australia
Local Institution - 0397
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0337
🇦🇹Innsbruck, Tirol, Austria
Local Institution - 0284
🇧🇪Brasschaat, Antwerpen, Belgium
Local Institution - 0333
🇦🇹St. Polten, Niederösterreich, Austria
Local Institution - 0019
🇦🇺Clayton, Victoria, Australia
Local Institution - 0018
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0003
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0332
🇦🇹Wien, Austria
Local Institution - 0384
🇯🇵Tokyo, Japan
Local Institution - 0334
🇦🇹Salzburg, Austria
Local Institution - 0369
🇧🇷Sao Paulo, São Paulo, Brazil
Local Institution - 0105
🇭🇺Budapest, Hungary
Local Institution - 0350
🇬🇧Cardiff, United Kingdom
Local Institution - 0281
🇮🇪Cork, Ireland
Local Institution - 0344
🇬🇧Derby, United Kingdom
Local Institution - 0343
🇬🇧Manchester, United Kingdom
Local Institution - 0199
🇺🇸Cleveland, Ohio, United States
Local Institution - 0437
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0157
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0222
🇦🇷Florencio Varela, Buenos Aires, Argentina
Local Institution - 0002
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0260
🇦🇺Liverpool, New South Wales, Australia
Local Institution - 0021
🇦🇺Box Hill, Victoria, Australia
Local Institution - 0274
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0395
🇨🇦Toronto, Ontario, Canada
Local Institution - 0030
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0027
🇨🇱Santiago, Metropolitana DE Santiago, Chile
Local Institution - 0026
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0029
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0230
🇨🇳Beijing, Beijing, China
Local Institution - 0226
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0062
🇨🇳Changsha, Hunan, China
Local Institution - 0075
🇨🇳Wuhan, Hubei, China
Local Institution - 0067
🇨🇳Suzhou, Jiangsu, China
Local Institution - 0044
🇨🇳Shenyang, Liaoning, China
Local Institution - 0077
🇨🇳Jinan, Shandong, China
Local Institution - 0422
🇨🇳Tianjin, Tianjin, China
Local Institution - 0056
🇨🇳Tianjin, Tianjin, China
Local Institution - 0203
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0367
🇨🇳Qingdao, China
Local Institution - 0118
🇫🇷Toulouse, Haute-Garonne, France
Local Institution - 0013
🇨🇿Brno, Brno-město, Czechia
Local Institution - 0247
🇨🇿Olomouc, Olomoucký Kraj, Czechia
Local Institution - 0224
🇫🇷Vandoeuvre lès Nancy, Lorraine, France
Local Institution - 0012
🇨🇿Praha 2, Czechia
Local Institution - 0085
🇫🇷Nantes, Pays-de-la-Loire, France
Local Institution - 0329
🇩🇪Leipzig, Sachsen, Germany
Local Institution - 0192
🇫🇷Pierre-Bénite, Rhône, France
Local Institution - 0331
🇩🇪Heidelberg, Baden-Württemberg, Germany
Local Institution - 0330
🇩🇪Tübingen, Baden-Württemberg, Germany
Local Institution - 0004
🇬🇷Athens, Attikí, Greece
Local Institution - 0339
🇩🇪Hamburg, Germany
Local Institution - 0371
🇮🇪Dublin, Ireland
Local Institution - 0294
🇮🇹Legnano, Milano, Italy
Local Institution - 0265
🇮🇹Milan, Milano, Italy
Local Institution - 0410
🇮🇹Palermo, Sicilia, Italy
Local Institution - 0409
🇯🇵Anjo, Aichi, Japan
Local Institution - 0385
🇯🇵Kashiwa, Chiba, Japan
Local Institution - 0390
🇯🇵Osaka-sayama, Osaka, Japan
Local Institution - 0383
🇯🇵Chiba, Japan
Local Institution - 0391
🇯🇵Kumamoto, Japan
Local Institution - 0389
🇯🇵Kyoto, Japan
Local Institution - 0388
🇯🇵Okayama, Japan
Local Institution - 0240
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Local Institution - 0221
🇰🇷Busan, Pusan-Kwangyǒkshi, Korea, Republic of
Local Institution - 0239
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0035
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0255
🇵🇹Lisboa, Portugal
Local Institution - 0169
🇷🇴Bucuresti, București, Romania
Local Institution - 0171
🇷🇴Brasov, Romania
Local Institution - 0414
🇷🇴București, Romania
Local Institution - 0011
🇪🇸Badalona, Barcelona [Barcelona], Spain
Local Institution - 0234
🇪🇸El Palmar, Murcia, Murcia, Región De, Spain
Local Institution - 0008
🇪🇸Pamplona, Navarra, Spain
Local Institution - 0006
🇪🇸Salamanca, Spain
Local Institution - 0202
🇪🇸Jerez de la Frontera, Spain
Local Institution - 0007
🇪🇸Santiago de Compostela, Spain
Local Institution - 0009
🇪🇸València, Spain
Local Institution - 0111
🇸🇪Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0114
🇸🇪Borås, Västra Götalands Län [se-14], Sweden
Local Institution - 0411
🇨🇭st.Gallen, Sankt Gallen, Switzerland
Local Institution - 0325
🇹🇷Stanbul, İstanbul, Turkey
Local Institution - 0338
🇨🇭Zürich, Switzerland
Local Institution - 0375
🇹🇷Ankara, Turkey
Local Institution - 0188
🇹🇷İzmir, Turkey
Local Institution - 0349
🇬🇧Southampton, Hampshire, United Kingdom
Local Institution - 0342
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0405
🇺🇸Seattle, Washington, United States
Local Institution - 0413
🇨🇳Beijing, Beijing, China
Local Institution - 0040
🇨🇳Beijing, Beijing, China
Local Institution - 0366
🇨🇳Changping, Beijing, China
Local Institution - 0057
🇨🇳Chongqing, Chongqing, China
Local Institution - 0368
🇨🇳Shenzhen, Guangdong, China
Local Institution - 0365
🇨🇳Baoding, Hebei, China
Local Institution - 0066
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0080
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0082
🇨🇳Shijiazhuang, Hebei, China
Local Institution - 0041
🇨🇳Zhengzhou, Henan, China
Local Institution - 0053
🇨🇳Changsha, Hunan, China
Local Institution - 0377
🇨🇳Xuzhou, Jiangsu, China
Local Institution - 0083
🇨🇳Jinan, Shandong, China
Local Institution - 0273
🇨🇳Shanghai, Shanghai, China
Local Institution - 0072
🇨🇳Xi'An, Shaanxi, China
Local Institution - 0055
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0245
🇨🇳Taiyuan, Shanxi, China
Local Institution - 0070
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0421
🇨🇳Shanghai, Shanghai, China
Local Institution - 0351
🇧🇷Natal, Rio Grande Do Norte, Brazil
Local Institution - 0279
🇧🇪Yvoir, Namur, Belgium
Local Institution - 0358
🇺🇸Stanford, California, United States
Local Institution - 0396
🇺🇸New York, New York, United States
Local Institution - 0430
🇺🇸Lake Success, New York, United States
Local Institution - 0439
🇺🇸Saint Matthews, Kentucky, United States
Local Institution - 0306
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0168
🇺🇸Dallas, Texas, United States
Local Institution - 0031
🇨🇦Montreal, Quebec, Canada
Local Institution - 0225
🇫🇷Montpellier, Languedoc-Roussillon, France
Local Institution - 0362
🇮🇳Gurugram, Haryana, India
Local Institution - 0104
🇭🇺Budapest, Hungary
Local Institution - 0096
🇮🇹Meldola, Emilia-Romagna, Italy
Local Institution - 0269
🇮🇪Limerick, Ireland
Local Institution - 0398
🇮🇳Kolkata, West Bengal, India
Local Institution - 0407
🇯🇵Kamogawa, Chiba, Japan
Local Institution - 0386
🇯🇵Isehara, Kanagawa, Japan
Local Institution - 0419
🇯🇵Aomori, Japan
Local Institution - 0382
🇯🇵Koto, Tokyo, Japan
Local Institution - 0034
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0115
🇳🇴Bergen, Hordaland, Norway
Local Institution - 0415
🇵🇹Lisbon, Lisboa, Portugal
Local Institution - 0036
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0193
🇳🇴Oslo, Norway
Local Institution - 0137
🇳🇴Løenskog, Akershus, Norway
Local Institution - 0242
🇵🇹Lisbon, Lisboa, Portugal
Local Institution - 0336
🇨🇭Bern, Berne, Switzerland
Local Institution - 0187
🇹🇷Kayseri, Turkey
Local Institution - 0151
🇺🇸Birmingham, Alabama, United States
Local Institution - 0355
🇺🇸New Haven, Connecticut, United States
Local Institution - 0280
🇧🇪Verviers, Liège, Belgium
Local Institution - 0286
🇧🇪Leuven, Vlaams-Brabant, Belgium
Local Institution - 0098
🇨🇦Montréal, Quebec, Canada
Local Institution - 0285
🇮🇪Dublin, Ireland
Local Institution - 0381
🇯🇵Shimotsuga, Tochigi, Japan
Local Institution - 0417
🇨🇦Calgary, Alberta, Canada
Local Institution - 0084
🇫🇷Lille, Nord, France
Local Institution - 0335
🇩🇪Dresden, Sachsen, Germany
Local Institution - 0262
🇦🇷Pilar, Buenos Aires, Argentina
Local Institution - 0359
🇺🇸Summit, New Jersey, United States
Local Institution - 0103
🇭🇺Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary
Local Institution - 0108
🇭🇺Szombathely, Vas, Hungary
Local Institution - 0423
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0441
🇺🇸Bethesda, Maryland, United States
Local Institution - 0001
🇦🇷La Plata, Buenos Aires, Argentina
Local Institution - 0291
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0211
🇧🇷São Paulo, Brazil
Local Institution - 0136
🇬🇷Chaidari, Attikí, Greece
Local Institution - 0403
🇮🇳Bangalore, Karnataka, India
Local Institution - 0387
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0402
🇨🇦London, Ontario, Canada
Local Institution - 0370
🇮🇳Visakhapatnam, Andhra Pradesh, India
Local Institution - 0399
🇮🇳Lucknow, Uttar Pradesh, India
Local Institution - 0433
🇺🇸Wichita, Kansas, United States