A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2) (SUCCESSOR-2)

April 10, 2024 updated by: Bristol-Myers Squibb

A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

525

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 Locations

      • Buenos Aires, Argentina, 1431
        • Recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Córdoba, Argentina, 5000
        • Recruiting
        • Sanatorio Allende - Nueva Córdoba
        • Contact:
          • Gustavo Jarchum, Site 0151
          • Phone Number: 03514269294
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming
        • Contact:
          • Paola Ochoa, Site 0008
          • Phone Number: +54 9 11 6579-1019
    • Ciudad Autónoma De Buenos Aires
      • ABB, Ciudad Autónoma De Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Dorotea Fantl, Site 0079
          • Phone Number: 0054 9 1151097180
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Recruiting
        • Fundacion Estudios Clinicos
        • Contact:
          • GUSTAVO BRAIDOT, Site 0182
          • Phone Number: +5493416149225
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Phoebe Ho, Site 0077
          • Phone Number: 61295158031
      • Gosford, New South Wales, Australia, 2250
        • Recruiting
        • Gosford Hospital
        • Contact:
          • Cecily Forsyth, Site 0160
          • Phone Number: 0404484360
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • Port Macquarie - Mid North Coast Cancer Institute
        • Contact:
          • Jock Simpson, Site 0263
          • Phone Number: +61265801807
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Contact:
          • Christopher Ward, Site 0078
          • Phone Number: +61299264377
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Georgia Mccaughan, Site 0026
          • Phone Number: 61293555656
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Cindy Lee, Site 0024
          • Phone Number: +61870744100
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Withdrawn
        • Local Institution - 0229
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Recruiting
        • Bendigo Health Care Group
        • Contact:
          • Nora Lee, Site 0131
          • Phone Number: 0354542285
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Freemasons
        • Contact:
          • Henry Prince, Site 0224
          • Phone Number: +61385604010
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
          • Jay Hocking, Site 0127
          • Phone Number: +61394965093
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Hang Quach, Site 0025
          • Phone Number: +61 3 9231 3189
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz Gmbh Elisabethinen
        • Contact:
          • Irene Strassl, Site 0020
          • Phone Number: 004373276764411
      • Wien, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien
        • Contact:
          • Maria-Theresa Krauth, Site 0017
          • Phone Number: 004314040044100
      • Wien, Austria, 1130
        • Withdrawn
        • Local Institution - 0119
    • Wien
      • Vienna, Wien, Austria, 1060
        • Not yet recruiting
        • Local Institution - 0266
        • Contact:
          • Site 0266
      • Rio de Janeiro, Brazil, 22250-905
        • Withdrawn
        • Local Institution - 0086
      • Rio de Janeiro, Brazil, 20775-001
        • Recruiting
        • Instituto de Educação, Pesquisa e Gestão em Saúde
        • Contact:
          • Angelo Maiolino, Site 0075
          • Phone Number: +5521981116663
      • São Paulo, Brazil, 04537-080
        • Recruiting
        • Clínica Médica São Germano S/S Ltda
        • Contact:
          • Vania Hungria, Site 0073
          • Phone Number: +5511999346820
    • Bahia
      • Salvador, Bahia, Brazil, 41253-190
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
        • Contact:
          • EDVAN CRUSOE, Site 0121
          • Phone Number: 557132816965
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
        • Recruiting
        • Hospital do Câncer Mãe de Deus
        • Contact:
          • Marcelo Capra, Site 0076
          • Phone Number: 5551999538883
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center
        • Contact:
          • Jayr Schmidt Filho, Site 0085
          • Phone Number: +5511953790662
      • Plovdiv, Bulgaria, 4002
        • Not yet recruiting
        • Local Institution - 0305
        • Contact:
          • Site 0305
      • Sofia, Bulgaria, 1407
        • Not yet recruiting
        • Local Institution - 0309
        • Contact:
          • Site 0309
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1431
        • Not yet recruiting
        • Local Institution - 0304
        • Contact:
          • Site 0304
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site
        • Contact:
          • Darrell White, Site 0183
          • Phone Number: 9024734642
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital & Children's Hospital - London Health Sciences Centre
        • Contact:
          • Martha Louzada, Site 0275
          • Phone Number: 519685850052391
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Donna Reece, Site 0184
          • Phone Number: 4169462824
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Withdrawn
        • Local Institution - 0186
      • Taiyuan, China, 030032
        • Recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
    • Anhui
      • Hefei, Anhui, China, 230031
        • Not yet recruiting
        • Local Institution - 0318
        • Contact:
          • Site 0318
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
          • wen gao, Site 0061
          • Phone Number: +8613651275440
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Peking Union Medical College Hospital
        • Contact:
          • Junling Zhuang, Site 0056
          • Phone Number: 8613910118511
      • Beijing City, Beijing, China, 100043
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
          • Zhongxia Huang, Site 0057
          • Phone Number: 13366395016
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Zhongjun Xia, Site 0138
          • Phone Number: 8613602713223
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Local Institution - 0315
        • Contact:
          • Site 0315
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
      • Wuhan, Hubei, China, 430002
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Chunyan Sun, Site 0066
          • Phone Number: +86 15342346782
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
          • Jing Liu, Site 0071
          • Phone Number: 13787318069
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Local Institution - 0103
        • Contact:
          • Site 0103
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
          • Xiaoping Zhang, Site 0180
          • Phone Number: 18001581408
      • Nantong, Jiangsu, China, 226001
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
          • Hongming Huang, Site 0111
          • Phone Number: 15006281688
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Chengcheng Fu, Site 0104
          • Phone Number: 13962191404
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • WuXi People's Hospital
        • Contact:
          • xin zhou, Site 0069
          • Phone Number: 13358111962
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital Of NanChang University
        • Contact:
          • qingming wang, Site 0095
          • Phone Number: 13407911812
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • sujun gao, Site 0052
          • Phone Number: +86 15843073208
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • ShengJing Hospital Of China Medical University
        • Contact:
          • wei yang, Site 0176
          • Phone Number: 18940251012
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Xiaojing Yan, Site 0096
          • Phone Number: 13889128302
    • Shaanxi
      • Xi'an, Shaanxi, China, 710126
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
          • YingMin Liang, Site 0060
          • Phone Number: 13891966009
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University (Qingdao)
        • Contact:
          • Ming Hou, Site 0072
          • Phone Number: 13791122627
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
      • Shanghai, Shanghai, China, 200081
        • Not yet recruiting
        • Local Institution - 0317
        • Contact:
          • Site 0317
    • Tianjin
      • Tianjing, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Yafei Wang, Site 0091
          • Phone Number: +8613820914401
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • Recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Zhen Cai, Site 0050
          • Phone Number: 13857190311
      • Wenzhou, Zhejiang, China, 32500
        • Not yet recruiting
        • Local Institution - 0115
        • Contact:
          • Site 0115
    • Antioquia
      • Medellin, Antioquia, Colombia, 05034
        • Recruiting
        • Hospital Pablo Tobon Uribe
        • Contact:
          • Kenny Galvez, Site 0153
          • Phone Number: 5731489056030000
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Recruiting
        • Sociedad de Oncologia y Hematologia del Cesar
        • Contact:
          • Carmen Rosales, Site 0156
          • Phone Number: 3112620177
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111151
        • Not yet recruiting
        • Local Institution - 0154
        • Contact:
          • Site 0154
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760035
        • Not yet recruiting
        • Local Institution - 0155
        • Contact:
          • Site 0155
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Contact:
          • Maja Vase, Site 0032
          • Phone Number: 4521423108
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Recruiting
        • Roskilde Sygehus
        • Contact:
          • Trung Hieu Do, Site 0065
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital
        • Contact:
          • Charlotte Hansen, Site 0129
          • Phone Number: +4530535733
      • Vejle, Syddanmark, Denmark, 7100
        • Recruiting
        • Local Institution - 0125
        • Contact:
          • Site 0125
      • Berlin, Germany, 12203
        • Recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
      • Heidelberg, Germany, D-69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
        • Contact:
          • Marc-Steffen Raab, Site 0015
          • Phone Number: 496221565427
      • Köln, Germany, 50937
        • Recruiting
        • Local Institution - 0102
        • Contact:
          • Site 0102
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitatsklinikum Leipzig
        • Contact:
          • Maximilian Merz, Site 0030
          • Phone Number: 0049 341 97 13050
      • Nürnberg, Germany, 90419
        • Recruiting
        • Local Institution - 0133
        • Contact:
          • Site 0133
      • Ulm, Germany, 89081
        • Recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
      • Wuerzburg, Germany, 97080
        • Recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
        • Contact:
          • Natalie Schub, Site 0029
          • Phone Number: +4943150022711
    • Achaḯa
      • Patras, Achaḯa, Greece, 26504
        • Recruiting
        • University Hospital of Patras
        • Contact:
          • Argiris Symeonidis, Site 0136
          • Phone Number: 302610999247
    • Attikí
      • Athens, Attikí, Greece, 11528
        • Recruiting
        • Alexandra General Hospital of Athens
        • Contact:
          • MELETIOS DIMOPOULOS, Site 0135
          • Phone Number: +306932418798
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 10
        • Recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Yok Lam Kwong, Site 0178
          • Phone Number: 85222555859
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis Egyetem
        • Contact:
          • Gergely Varga, Site 0042
          • Phone Number: +36208258799
      • Budapest, Hungary, 1097
        • Recruiting
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
        • Contact:
          • Gabor MIKALA Dr, Site 0019
          • Phone Number: +36209139907
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
        • Contact:
          • Arpad Illes, Site 0043
          • Phone Number: 36303263397
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Recruiting
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
        • Contact:
          • Laszlo Rejto, Site 0094
          • Phone Number: 42599700
      • Chandigarh, India, 160012
        • Not yet recruiting
        • Local Institution - 0230
        • Contact:
          • Site 0230
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500068
        • Not yet recruiting
        • Local Institution - 0310
        • Contact:
          • Site 0310
    • Delhi
      • New Delhi, Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute and Research Centre
        • Contact:
          • Narendra Agrawal, Site 0170
          • Phone Number: 919868764808
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Not yet recruiting
        • Local Institution - 0167
        • Contact:
          • Site 0167
    • Karnataka
      • Bengaluru, Karnataka, India, 560027
        • Not yet recruiting
        • Local Institution - 0161
        • Contact:
          • Site 0161
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Not yet recruiting
        • Local Institution - 0168
        • Contact:
          • Site 0168
      • Thane, Maharashtra, India, 400602
        • Recruiting
        • Mumbai Oncocare Centre - Thane
        • Contact:
          • Preetam Kalaskar, Site 0171
          • Phone Number: 918828000863
    • Punjab
      • Mohali, Punjab, India, 160055
        • Recruiting
        • Max Super Specialty Hospital - Mohali
        • Contact:
          • Gautam Goyal, Site 0261
          • Phone Number: 8195849111
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600036
        • Recruiting
        • Local Institution - 0174
        • Contact:
          • Site 0174
    • Telangana
      • Hyderabad, Telangana, India, 500033
        • Recruiting
        • Apollo Institute of Medical Sciences and Research
        • Contact:
          • Prasad S, Site 0165
          • Phone Number: 9848018804
      • Hyderabad, Telangana, India, 500084
        • Recruiting
        • Yashoda Hospitals - Hitech City
        • Contact:
          • Ganesh Jaishetwar, Site 0164
          • Phone Number: 9849388806
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Moshe Gatt, Site 0277
          • Phone Number: 97226779268
      • Zerifin, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
        • Contact:
          • Katrin Herzog Tzarfati, Site 0267
          • Phone Number: +972-8-9779760
    • HaMerkaz
      • Holon, HaMerkaz, Israel, 5810001
        • Recruiting
        • Edith Wolfson Medical Center
        • Contact:
          • Nadav Sarid, Site 0264
          • Phone Number: 972-747624588
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Michele Cavo, Site 0189
          • Phone Number: 390516363680
      • Catanzaro, Italy, 88100
        • Recruiting
        • Azienda Ospedaliera "Pugliese Ciaccio"
        • Contact:
          • Marco Rossi, Site 0148
          • Phone Number: +393316718269
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale Vito Fazzi
        • Contact:
          • Nicola Di Renzo, Site 0147
          • Phone Number: +39 330325013
      • Pisa, Italy, 56100
        • Recruiting
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
          • Sara Galimberti, Site 0144
          • Phone Number: +393470038656
      • Udine, Italy, 33100
        • Recruiting
        • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
        • Contact:
          • FRANCESCA PATRIARCA, Site 0146
          • Phone Number: 0432559618
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
        • Contact:
          • Claudio Cerchione, Site 0145
          • Phone Number: +393475533565
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Contact:
          • Loredana Pettine, Site 0143
          • Phone Number: +390255033477
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas
        • Contact:
          • Armando Santoro, Site 0142
          • Phone Number: 390282244080
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
          • Emiko Sakaida, Site 0215
          • Phone Number: +81432227171
      • Fukuoka, Japan, 815-8555
        • Recruiting
        • Japanese Red Cross Fukuoka Hospital
        • Contact:
          • Kazuki Tanimoto, Site 0235
          • Phone Number: +81-92-521-1211
      • Fukuoka, Japan, 810-8563
        • Not yet recruiting
        • Local Institution - 0226
        • Contact:
          • Site 0226
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University
        • Contact:
          • Yawara Kawano, Site 0220
          • Phone Number: +81-96-373-5156
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Contact:
          • Junya Kuroda, Site 0216
          • Phone Number: 81752515740
      • Nagasaki, Japan, 852-8104
        • Not yet recruiting
        • Local Institution - 0213
        • Contact:
          • Site 0213
      • Okayama, Japan, 701-1192
        • Recruiting
        • National Hospital Organization Okayama Medical Center
        • Contact:
          • Kazutaka Sunami, Site 0212
          • Phone Number: 81862949911
      • Osaka, Japan, 545-8586
        • Not yet recruiting
        • Local Institution - 0301
        • Contact:
          • Site 0301
      • Tokyo, Japan, 150-8935
        • Recruiting
        • Japanese Red Cross Medical Center
        • Contact:
          • Tadao Ishida, Site 0218
          • Phone Number: 8133400104
      • Tokyo, Japan, 105-8461
        • Not yet recruiting
        • Local Institution - 0241
        • Contact:
          • Site 0241
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
          • Shinsuke Iida, Site 0269
          • Phone Number: 81528515511
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • Junichiro Yuda, Site 0214
          • Phone Number: 04-7133-1111
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 806-8501
        • Recruiting
        • Japan Community Healthcare Organization Kyushu Hospital
        • Contact:
          • Ryosuke Ogawa, Site 0210
          • Phone Number: +81936415111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Not yet recruiting
        • Local Institution - 0211
        • Contact:
          • Site 0211
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 3113117
        • Recruiting
        • Mito Medical Center
        • Contact:
          • Takuya Komeno, Site 0217
          • Phone Number: 81292407711
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Not yet recruiting
        • Local Institution - 0300
        • Contact:
          • Site 0300
    • Iwate
      • Shiwa-gun Yahaba-cho, Iwate, Japan, 028-3695
        • Not yet recruiting
        • Local Institution - 0209
        • Contact:
          • Site 0209
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
        • Not yet recruiting
        • Local Institution - 0234
        • Contact:
          • Site 0234
    • Saitama
      • Koshigaya, Saitama, Japan, 343-8555
        • Not yet recruiting
        • Local Institution - 0225
        • Contact:
          • Site 0225
    • Tokyo
      • Itabashiku, Tokyo, Japan, 173-8610
        • Not yet recruiting
        • Local Institution - 0236
        • Contact:
          • Site 0236
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
          • Dai Maruyama, Site 0219
          • Phone Number: +81-3-3520-0111
    • Yamanashi
      • Chuo, Yamanashi, Japan, 409-3898
        • Not yet recruiting
        • Local Institution - 0303
        • Contact:
          • Site 0303
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Ja Min Byun, Site 0238
          • Phone Number: 821071243234
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Contact:
          • Chang Ki Min, Site 0240
          • Phone Number: 82-20-2258-6053
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Recruiting
        • Local Institution - 0239
        • Contact:
          • Site 0239
      • Enschede, Netherlands, 7512 KZ
        • Not yet recruiting
        • Local Institution - 0194
        • Contact:
          • Site 0194
    • Noord-Brabant
      • Breda, Noord-Brabant, Netherlands, 4818 CK
        • Not yet recruiting
        • Local Institution - 0113
        • Contact:
          • Site 0113
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo Universitetssykehus Ullevål
        • Contact:
          • Fredrik Schjesvold, Site 0081
          • Phone Number: 4799697796
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Recruiting
        • Haukeland Universitetssjukehus
        • Contact:
          • Galina Tsykunova, Site 0049
          • Phone Number: +4790670517
    • Rogaland
      • Stavanger, Rogaland, Norway, 4011
        • Recruiting
        • Stavanger Universitetssykehus
        • Contact:
          • Einar Haukås, Site 0112
          • Phone Number: +47 5151 8383
      • San Juan, Puerto Rico, 00909
        • Not yet recruiting
        • Local Institution - 0316
        • Contact:
          • Site 0316
      • București, Romania, 030171
        • Not yet recruiting
        • Local Institution - 0287
        • Contact:
          • Site 0287
      • București, Romania, 022238
        • Not yet recruiting
        • Local Institution - 0302
        • Contact:
          • Site 0302
      • Sibiu, Romania, 550245
        • Not yet recruiting
        • Local Institution - 0306
        • Contact:
          • Site 0306
    • Brașov
      • Brasov, Brașov, Romania, 500152
        • Not yet recruiting
        • Local Institution - 0284
        • Contact:
          • Site 0284
    • București
      • Bucuresti, București, Romania, 022328
        • Not yet recruiting
        • Local Institution - 0282
        • Contact:
          • Site 0282
    • Timiș
      • Timișoara, Timiș, Romania, 300254
        • Withdrawn
        • Local Institution - 0290
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Chandramouli Nagarajan, Site 0159
          • Phone Number: 86157092
      • Singapore, Central Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
          • Wee Joo Chng, Site 0158
          • Phone Number: 6567724612
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario Virgen Nieves
        • Contact:
          • Esther Clavero Sánchez, Site 0107
          • Phone Number: 0034958020013
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • CRISTINA ENCINAS-RODRIGUEZ, Site 0200
          • Phone Number: +34915868443
      • Madrid, Spain, 28015
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Victor Jimenez Yuste, Site 0047
          • Phone Number: +34 91 727 7104
      • Málaga, Spain, 29010
        • Recruiting
        • H.R.U Málaga - Hospital General
        • Contact:
          • MARIA MAGDALENA ALCALA PEÑA, Site 0105
          • Phone Number: 0034 951 29 19 20
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona
        • Contact:
          • Albert Oriol Rocafiguera, Site 0126
          • Phone Number: 34934978987
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Mercedes Gironella Mesa, Site 0092
          • Phone Number: 932746100
      • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet
        • Contact:
          • Ana Maria Sureda Balari, Site 0038
          • Phone Number: 34932607750
    • Madrid, Comunidad De
      • Majadahonda, Madrid, Comunidad De, Spain, 28222
        • Recruiting
        • Local Institution - 0108
        • Contact:
          • Site 0108
    • Santa Cruz De Tenerife
      • San Cristobal de La laguna, Santa Cruz De Tenerife, Spain, 38320
        • Withdrawn
        • Local Institution - 0192
      • San Cristobal de La laguna, Santa Cruz De Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • SUNIL LAKHWANI, Site 0201
          • Phone Number: +34 922678207
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
      • Kaohsiung, Taiwan, 82445
        • Recruiting
        • E-DA Cancer Hospital
        • Contact:
          • Sung-Nan Pei, Site 0012
          • Phone Number: +886-7-6150022
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Chieh-Lin Teng, Site 0001
          • Phone Number: 0423592525EXT3176
      • Tainan, Taiwan, 704
        • Recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Chia-Jen Liu, Site 0162
          • Phone Number: +886-2-28757529
      • Taipei, Taiwan, 11217
        • Withdrawn
        • Local Institution - 0149
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 613
        • Recruiting
        • Chang Gung Memorial Hospital- Chiayi
        • Contact:
          • Chih-Cheng Chen, Site 0274
          • Phone Number: 0975353099
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
        • Contact:
          • Ming-Chun Ma, Site 0177
          • Phone Number: 0975056057
      • Birmingham, United Kingdom, B15 2TH
        • Withdrawn
        • Local Institution - 0039
      • Birmingham, United Kingdom, B9 5SS
        • Not yet recruiting
        • Local Institution - 0273
        • Contact:
          • Site 0273
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • The Beatson West of Scotland Cancer Centre
        • Contact:
          • jennifer travers, Site 0196
          • Phone Number: 01413017712
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Contact:
          • Christopher Parrish, Site 0080
          • Phone Number: 07968 191048
      • Taunton, United Kingdom, TA1 5DA
        • Recruiting
        • Musgrove Park Hospital
        • Contact:
          • Oliver MILES, Site 0040
          • Phone Number: 07946455539
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • hannah Hunter, Site 0139
          • Phone Number: 01752431003
    • England
      • Cringleford, England, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
        • Contact:
          • Cesar Gomez, Site 0067
          • Phone Number: 01603 286894
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Mitchell Cancer Institute
        • Contact:
          • Omar Alkharabsheh, Site 0046
          • Phone Number: 251-665-8000
    • California
      • Cerritos, California, United States, 90703
        • Recruiting
        • TOI Clinical Research
        • Contact:
          • Amitabha Mazumder, Site 0005
          • Phone Number: 562-693-4477
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente - Irvine
        • Contact:
          • Ashraf Aziz, Site 0190
          • Phone Number: 800-398-3996
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Los Angeles Hematology Oncology Medical Group
        • Contact:
          • Lasika Seneviratne, Site 0187
          • Phone Number: 626-627-6666
    • Delaware
      • Newark, Delaware, United States, 19713
        • Not yet recruiting
        • Local Institution - 0279
        • Contact:
          • Site 0279
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Winship Cancer Institute, Emory University
        • Contact:
          • Leon Bernal-Mizrachi, Site 0291
          • Phone Number: 678-787-7893
    • Idaho
      • Boise, Idaho, United States, 83706
        • Not yet recruiting
        • Saint Alphonsus Regional Medical Center
        • Contact:
          • Bobby Chawla, Site 0203
          • Phone Number: 208-367-3131
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Not yet recruiting
        • Local Institution - 0289
        • Contact:
          • Site 0289
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Monique Hartley-Brown, Site 0204
          • Phone Number: 857-299-5736
    • New Jersey
      • Little Silver, New Jersey, United States, 07739
        • Recruiting
        • Regional Cancer Care Associates
        • Contact:
          • iuliana Shapira, Site 0222
          • Phone Number: 732-530-8666
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Nishi Shah, Site 0199
          • Phone Number: 718-920-4826
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Withdrawn
        • University of North Carolina Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Contact:
          • Yvonne Efebera, Site 0172
          • Phone Number: 216-965-8569
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Withdrawn
        • Charleston Oncology, P.A.
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • Carrie Yuen, Site 0044
          • Phone Number: 832-571-7244
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Center - Temple
        • Contact:
          • Rex Garland, Site 0195
          • Phone Number: 254-724-5918
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties PLLC
        • Contact:
          • Francis Senecal, Site 0006
          • Phone Number: 253-428-8700
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • WVU Cancer Institute
        • Contact:
          • Salah ud din Safi, Site 0243
          • Phone Number: 304-598-6984

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.

i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.

ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.

  • Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).
  • Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible).
  • Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
  • Participant must have documented disease progression during or after their last antimyeloma regimen.

Exclusion Criteria

  • Participant who has had prior treatment with mezigdomide or carfilzomib.
  • Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
  • 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
Active Comparator: Kd (Carfilzomib + Dexamethasone)
Specified dose on specified days
Other Names:
  • Decadron
  • Dex
Specified dose on specified days
Other Names:
  • Kyprolis
Experimental: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
Specified dose on specified days
Other Names:
  • Decadron
  • Dex
Specified dose on specified days
Other Names:
  • Kyprolis
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival 2 (PFS-2)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)
Time Frame: Up to approximately 5 years
VGPRR will be calculated as the percentage of participants who achieve best response of VGPR or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.
Up to approximately 5 years
Time To Response (TTR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Duration Of Response (DOR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time To Progression (TTP)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time To Next Treatment (TTNT)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Minimal Residual Disease (MRD) Negativity Rate
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number Of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Overall Response (OR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Recommended Mezigdomide Dose
Time Frame: Up to 12 months
Stage 1 only
Up to 12 months
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Time Frame: Up to 176 days
Stage 1 only
Up to 176 days
Complete Response (CR) Or Better (CRR)
Time Frame: Up to approximately 5 years
CRR will be calculated as the percentage of participants who achieve best response of CR or better according to the IMWG Uniform Response Criteria for Multiple Myeloma.
Up to approximately 5 years
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Time Frame: Up to approximately 5 years
The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only.
Up to approximately 5 years
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Time Frame: Up to approximately 5 years
The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only.
Up to approximately 5 years

Collaborators and Investigators

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

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 (Actual)

January 10, 2023

Primary Completion (Estimated)

February 4, 2026

Study Completion (Estimated)

July 25, 2029

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 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 Myers 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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