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)
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Registration Number
- NCT05552976
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 525
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) Dexamethasone - Kd (Carfilzomib + Dexamethasone) Carfilzomib - MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) Mezigdomide - Kd (Carfilzomib + Dexamethasone) Dexamethasone - MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) Carfilzomib -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to approximately 5 years
- Secondary Outcome Measures
Name Time Method Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR) 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.
Time To Response (TTR) Up to approximately 5 years Progression-free Survival 2 (PFS-2) Up to approximately 5 years Number Of Participants With Adverse Events (AEs) Up to approximately 5 years Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) 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.
Recommended Mezigdomide Dose Up to 12 months Stage 1 only
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone Up to 176 days Stage 1 only
Overall Survival (OS) Up to approximately 5 years Overall Response (OR) Up to approximately 5 years Complete Response (CR) Or Better (CRR) 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.
Duration Of Response (DOR) Up to approximately 5 years Time To Progression (TTP) Up to approximately 5 years Time To Next Treatment (TTNT) Up to approximately 5 years Minimal Residual Disease (MRD) Negativity Rate 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) 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.
Trial Locations
- Locations (215)
Local Institution - 0058
🇨🇳Kunming, Yunnan, China
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
USA Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
TOI Clinical Research
🇺🇸Cerritos, California, United States
Kaiser Permanente - Irvine
🇺🇸Irvine, California, United States
Los Angeles Hematology Oncology Medical Group
🇺🇸Los Angeles, California, United States
Sutter Santa Rosa
🇺🇸Santa Rosa, California, United States
Stockton Hematology Oncology Group
🇺🇸Stockton, California, United States
Local Institution - 0279
🇺🇸Newark, Delaware, United States
Local Institution - 0102
🇩🇪Köln, Germany
Florida Cancer Specialists - South
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists - North
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists - East
🇺🇸West Palm Beach, Florida, United States
Emory University School of Medicine- Grady Campus
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Regional Cancer Care Associates
🇺🇸Little Silver, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States
Charleston Oncology, P.A.
🇺🇸Charleston, South Carolina, United States
Local Institution - 0338
🇺🇸Greer, South Carolina, United States
Local Institution - 0349
🇺🇸Chattanooga, Tennessee, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
John Peter Smith Hospital
🇺🇸Fort Worth, Texas, United States
Kelsey-Seybold Clinic
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Local Institution - 0195
🇺🇸Temple, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Northwest Medical Specialties PLLC
🇺🇸Tacoma, Washington, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancouver, Washington, United States
WVU Cancer Institute
🇺🇸Morgantown, West Virginia, United States
Marshfield Medical Center - Marshfield
🇺🇸Marshfield, Wisconsin, United States
Instituto Alexander Fleming
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, Argentina
C.I.C.E. 9 de Julio
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
🇦🇷Buenos Aires, Argentina
Sanatorio Allende - Nueva Córdoba
🇦🇷Córdoba, Argentina
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Port Macquarie - Mid North Coast Cancer Institute
🇦🇺Port Macquarie, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
St Vincent's Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0229
🇦🇺Hobart, Tasmania, Australia
Bendigo Health Care Group
🇦🇺Bendigo, Victoria, Australia
Epworth Freemasons
🇦🇺East Melbourne, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Krankenhaus der Barmherzigen Schwestern Wien
🇦🇹Vienna, Wien, Austria
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Local Institution - 0119
🇦🇹Wien, Austria
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
🇧🇷Salvador, Bahia, Brazil
Hospital do Câncer Mãe de Deus
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
A. C. Camargo Cancer Center
🇧🇷Sao Paulo, São Paulo, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0086
🇧🇷Rio de Janeiro, Brazil
Clínica Médica São Germano S/S Ltda
🇧🇷São Paulo, Brazil
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
🇧🇬Plovdiv, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
🇧🇬Sofia, Bulgaria
UMHAT 'Sveti Ivan Rilsky'
🇧🇬Sofia, Bulgaria
QEII Health Sciences Centre - Victoria General Site
🇨🇦Halifax, Nova Scotia, Canada
Victoria Hospital & Children's Hospital - London Health Sciences Centre
🇨🇦London, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Local Institution - 0186
🇨🇦Montreal, Quebec, Canada
Local Institution - 0318
🇨🇳Hefei, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital-1 Bingfanglou
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0315
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital Tongji Medical,Science & Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Medanta-The Medicity
🇮🇳Gurgaon, Haryana, India
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Local Institution - 0060
🇨🇳Xi'an, Shaanxi, China
Qilu Hospital of Shandong University (Qingdao)
🇨🇳Jinan, Shandong, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Tongji University - Shanghai Fourth People's Hospital
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute And Hospital
🇨🇳Tianjing, Tianjin, China
The first Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar
🇨🇴Valledupar, Cesar, Colombia
Instituto Nacional De Cancerologia
🇨🇴Bogota, Cundinamarca, Colombia
Fundación Cardiovascular de Colombia
🇨🇴Piedecuesta, Santander, Colombia
IPS Centro Médico Julián Coronel S.A.S
🇨🇴Cali, Colombia
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Roskilde Sygehus
🇩🇰Roskilde, Sjælland, Denmark
Odense Universitetshospital
🇩🇰Odense, Syddanmark, Denmark
Vejle Sygehus
🇩🇰Vejle, Denmark
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden-Wurttemberg, Germany
Haematologie und Onkologie Muenchen-Pasing
🇩🇪Munich, Bayern, Germany
Klinikum Nuernberg Nord, Urologische Klinik
🇩🇪Nürnberg, Bayern, Germany
Praxis Onkologie am Raschplatz
🇩🇪Hannover, Niedersachsen, Germany
GEFOS Gesellschaft f. onkologische Studien
🇩🇪Dortmund, Nordrhein-Westfalen, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
🇩🇪Berlin, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Marien Hospital Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
University Hospital of Patras
🇬🇷Patras, Achaḯa, Greece
Alexandra General Hospital of Athens
🇬🇷Athens, Attikí, Greece
G. Papanikolaou General Hospital
🇬🇷Thessaloniki, Thessaloníki, Greece
Queen Mary Hospital
🇭🇰Hksar, Hong Kong
Pécsi Tudományegyetem Klinikai Központ
🇭🇺Pécs, Baranya, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hajdú-Bihar, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
🇭🇺Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
🇭🇺Budapest, Hungary
Rajiv Gandhi Cancer Institute And Research Centre
🇮🇳New Delhi, Delhi, India
HCG-Bangalore
🇮🇳Bengaluru, Karnataka, India
Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Mumbai Oncocare Centre - Thane
🇮🇳Thane, Maharashtra, India
Max Super Specialty Hospital - Mohali
🇮🇳Mohali, Punjab, India
Cancer Institute (WIA)
🇮🇳Chennai, Tamil Nadu, India
Apollo Institute of Medical Sciences and Research
🇮🇳Hyderabad, Telangana, India
Kamineni Hospitals - L.B.Nagar
🇮🇳Hyderabad, Telangana, India
Yashoda Hospitals - Hitech City
🇮🇳Hyderabad, Telangana, India
Postgraduate Institute of Medical Education & Research
🇮🇳Chandigarh, India
Edith Wolfson Medical Center
🇮🇱Holon, HaMerkaz, Israel
Yitzhak Shamir Medical Center
🇮🇱Zerifin, HaMerkaz, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
🇮🇹Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Humanitas
🇮🇹Rozzano, Milano, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
🇮🇹Bologna, Italy
Azienda Ospedaliera "Pugliese Ciaccio"
🇮🇹Catanzaro, Italy
Ospedale Vito Fazzi
🇮🇹Lecce, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
🇮🇹Udine, Italy
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Japan Community Healthcare Organization Kyushu Hospital
🇯🇵Kitakyushu-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Mito Medical Center
🇯🇵Higashiibaraki, Ibaraki, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Iwate Medical University Hospital
🇯🇵Shiwa-gun Yahaba-cho, Iwate, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
Dokkyo Medical University Saitama Medical Center
🇯🇵Koshigaya, Saitama, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashiku, Tokyo, Japan
Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanashi, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Japanese Red Cross Fukuoka Hospital
🇯🇵Fukuoka, Japan
Kumamoto University
🇯🇵Kumamoto, Japan
University Hospital,Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
🇯🇵Nagasaki, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
The Jikei University Hospital
🇯🇵Tokyo, Japan
Japanese Red Cross Medical Center
🇯🇵Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Amphia Ziekenhuis, locatie Breda Molengracht
🇳🇱Breda, Noord-Brabant, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Haukeland Universitetssjukehus
🇳🇴Bergen, Hordaland, Norway
Stavanger Universitetssykehus
🇳🇴Stavanger, Rogaland, Norway
Oslo Universitetssykehus Ullevål
🇳🇴Oslo, Norway
Pan American Center for Oncology Trials - Ciudadela
🇵🇷San Juan, Puerto Rico
Fundeni Clinical Institute
🇷🇴Bucuresti, București, Romania
Local Institution - 0290
🇷🇴Timișoara, Timiș, Romania
Sc Onco Card Srl
🇷🇴Brasov, Romania
Affidea Fundeni
🇷🇴București, Romania
Spitalul Clinic Colțea
🇷🇴București, Romania
Spitalul Clinic Județean de Urgență Sibiu
🇷🇴Sibiu, Romania
National University Hospital
🇸🇬Singapore, Central Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Central Singapore, Singapore
Institut Catalan d Oncologia (ICO) - Badalona
🇪🇸Badalona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Institut Català d'Oncologia - L'Hospitalet
🇪🇸L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0108
🇪🇸Majadahonda, Madrid, Comunidad De, Spain
Hospital Universitario de Canarias
🇪🇸San Cristobal de La laguna, Santa Cruz De Tenerife, Spain
Local Institution - 0192
🇪🇸San Cristobal de La laguna, Santa Cruz De Tenerife, Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Nieves
🇪🇸Granada, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
H.R.U Málaga - Hospital General
🇪🇸Málaga, Spain
Chang Gung Memorial Hospital- Chiayi
🇨🇳Chiayi City, Chiayi, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
E-Da Cancer Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Local Institution - 0149
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
🇬🇧Cringleford, England, United Kingdom
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Glasgow City, United Kingdom
Local Institution - 0039
🇬🇧Birmingham, United Kingdom
Heartlands Hospital
🇬🇧Birmingham, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom