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)

Relapsed or Refractory Multiple Myeloma Clinical Trial

— SUCCESSOR-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552976
• Other study ID #: CA057-008
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2023
• Est. completion date: July 25, 2029

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: July 25, 2029
• Est. primary completion date: February 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?/? 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• Mezigdomide
Specified dose on specified days
• Carfilzomib
Specified dose on specified days
• Dexamethasone
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	ABB	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0150	Buenos Aires
Argentina	Instituto Alexander Fleming	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Sanatorio Allende - Nueva Córdoba	Córdoba
Argentina	Fundacion Estudios Clinicos	Rosario	Santa Fe
Argentina	Local Institution - 0319	San Miguel de Tucumán	Tucumán
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Bendigo Health Care Group	Bendigo	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Epworth Freemasons	East Melbourne	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	Local Institution - 0229	Hobart	Tasmania
Australia	St Vincent's Hospital	Melbourne	Victoria
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	Sydney	New South Wales
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz
Austria	Krankenhaus der Barmherzigen Schwestern Wien	Vienna	Wien
Austria	Local Institution - 0119	Wien
Austria	Medizinische Universität Wien	Wien
Brazil	Hospital do Câncer Mãe de Deus	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto de Educação, Pesquisa e Gestão em Saúde	Rio de Janeiro
Brazil	Local Institution - 0086	Rio de Janeiro
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador	Salvador	Bahia
Brazil	A. C. Camargo Cancer Center	Sao Paulo	São Paulo
Brazil	Clínica Médica São Germano S/S Ltda	São Paulo
Bulgaria	Local Institution - 0305	Plovdiv
Bulgaria	Local Institution - 0304	Sofia	Sofia (stolitsa)
Bulgaria	Local Institution - 0309	Sofia
Canada	QEII Health Sciences Centre - Victoria General Site	Halifax	Nova Scotia
Canada	Victoria Hospital & Children's Hospital - London Health Sciences Centre	London	Ontario
Canada	Local Institution - 0186	Montreal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Peking Union Medical College Hospital	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing City	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Local Institution - 0103	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Local Institution - 0123	Fuzhou	Fujian
China	Local Institution - 0315	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The first Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Local Institution - 0318	Hefei	Anhui
China	Qilu Hospital of Shandong University (Qingdao)	Jinan	Shandong
China	Local Institution - 0058	Kunming	Yunnan
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Local Institution - 0118	Shanghai	Shanghai
China	Local Institution - 0317	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Local Institution - 0059	Taiyuan
China	Tianjin Medical University Cancer Institute And Hospital	Tianjing	Tianjin
China	Local Institution - 0115	Wenzhou	Zhejiang
China	Local Institution - 0054	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Xi'an International Medical Center Hospital	Xi'an	Shaanxi
China	Local Institution - 0051	Zhengzhou	Henan
Colombia	Local Institution - 0154	Bogota	Cundinamarca
Colombia	IPS Centro Médico Julián Coronel S.A.S	Cali	Valle Del Cauca
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Colombia	Local Institution - 0324	Piedecuesta	Santander
Colombia	Sociedad De Oncologia Y Hematologia Del Cesar	Valledupar	Cesar
Denmark	Aarhus Universitetshospital, Skejby	Aarhus	Midtjylland
Denmark	Odense Universitetshospital	Odense	Syddanmark
Denmark	Roskilde Sygehus	Roskilde	Sjælland
Denmark	Local Institution - 0125	Vejle	Syddanmark
Germany	Charite Universitätsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-Holstein
Germany	Local Institution - 0102	Köln
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Local Institution - 0133	Nürnberg
Germany	Local Institution - 0124	Ulm
Germany	Local Institution - 0014	Wuerzburg
Greece	Alexandra General Hospital of Athens	Athens	Attikí
Greece	University Hospital of Patras	Patras	Acha?a
Greece	Local Institution - 0134	Thessaloniki	Thessaloníki
Hong Kong	Queen Mary Hospital	Hksar
Hungary	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen	Hajdú-Bihar
Hungary	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház	Nyiregyhaza	Szabolcs-Szatmár-Bereg
Hungary	Local Institution - 0036	Pécs	Baranya
India	HCG-Bangalore	Bengaluru	Karnataka
India	Local Institution - 0230	Chandigarh
India	Local Institution - 0174	Chennai	Tamil Nadu
India	Medanta-The Medicity	Gurgaon	Haryana
India	Apollo Institute of Medical Sciences and Research	Hyderabad	Telangana
India	Local Institution - 0310	Hyderabad	Andhra Pradesh
India	Yashoda Hospitals - Hitech City	Hyderabad	Telangana
India	Max Super Specialty Hospital - Mohali	Mohali	Punjab
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	Rajiv Gandhi Cancer Institute And Research Centre	New Delhi	Delhi
India	Mumbai Oncocare Centre - Thane	Thane	Maharashtra
Israel	Edith Wolfson Medical Center	Holon	HaMerkaz
Israel	Hadassah Medical Center	Jerusalem
Israel	Yitzhak Shamir Medical Center	Zerifin
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola	Bologna
Italy	Azienda Ospedaliera "Pugliese Ciaccio"	Catanzaro
Italy	Ospedale Vito Fazzi	Lecce
Italy	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	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Humanitas	Rozzano	Milano
Italy	P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale	Udine
Japan	Chiba University Hospital	Chiba
Japan	Local Institution - 0303	Chuo	Yamanashi
Japan	Japanese Red Cross Fukuoka Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Mito Medical Center	Higashiibaraki	Ibaraki
Japan	Local Institution - 0236	Itabashiku	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Local Institution - 0300	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Japan Community Healthcare Organization Kyushu Hospital	Kitakyushu-shi	Fukuoka
Japan	Local Institution - 0225	Koshigaya	Saitama
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	Kumamoto University	Kumamoto
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	Local Institution - 0301	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Local Institution - 0209	Shiwa-gun Yahaba-cho	Iwate
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	The Jikei University Hospital	Tokyo
Korea, Republic of	Local Institution - 0239	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Netherlands	Local Institution - 0113	Breda	Noord-Brabant
Netherlands	Local Institution - 0194	Enschede
Norway	Haukeland Universitetssjukehus	Bergen	Hordaland
Norway	Oslo Universitetssykehus Ullevål	Oslo
Norway	Stavanger Universitetssykehus	Stavanger	Rogaland
Puerto Rico	Local Institution - 0316	San Juan
Romania	Local Institution - 0284	Brasov	Bra?ov
Romania	Local Institution - 0287	Bucure?ti
Romania	Local Institution - 0302	Bucure?ti
Romania	Local Institution - 0282	Bucuresti	Bucure?ti
Romania	Local Institution - 0306	Sibiu
Romania	Local Institution - 0290	Timi?oara	Timi?
Singapore	National University Hospital	Singapore	Central Singapore
Singapore	Singapore General Hospital	Singapore	Central Singapore
Spain	Institut Català d'Oncologia (ICO) - Badalona	Badalona	Barcelona [Barcelona]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitario Virgen Nieves	Granada
Spain	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet Del Llobregat	Barcelona [Barcelona]
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Local Institution - 0108	Majadahonda	Madrid, Comunidad De
Spain	H.R.U Málaga - Hospital General	Málaga
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	Local Institution - 0037	Valencia	Valenciana, Comunitat
Taiwan	Chang Gung Memorial Hospital- Chiayi	Chiayi City	Chiayi
Taiwan	E-Da Cancer Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Local Institution - 0002	Tainan
Taiwan	Local Institution - 0149	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Local Institution - 0039	Birmingham
United Kingdom	Local Institution - 0273	Birmingham
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Cringleford	England
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Derriford Hospital	Plymouth	Devon
United Kingdom	Musgrove Park Hospital	Taunton
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	TOI Clinical Research	Cerritos	California
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Charleston Oncology, P.A.	Charleston	South Carolina
United States	Local Institution - 0322	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Houston Methodist Hospital	Houston	Texas
United States	Kaiser Permanente - Irvine	Irvine	California
United States	Regional Cancer Care Associates	Little Silver	New Jersey
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	USA Mitchell Cancer Institute	Mobile	Alabama
United States	WVU Cancer Institute	Morgantown	West Virginia
United States	Local Institution - 0279	Newark	Delaware
United States	Local Institution - 0321	Providence	Rhode Island
United States	Northwest Medical Specialties PLLC	Tacoma	Washington
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Denmark,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Puerto Rico,  Romania,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)		Up to approximately 5 years
Secondary	Recommended Mezigdomide Dose	Stage 1 only	Up to 12 months
Secondary	Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone	Stage 1 only	Up to 176 days
Secondary	Overall Survival (OS)		Up to approximately 5 years
Secondary	Overall Response (OR)		Up to approximately 5 years
Secondary	Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)	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
Secondary	Complete Response (CR) Or Better (CRR)	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
Secondary	Time To Response (TTR)		Up to approximately 5 years
Secondary	Duration Of Response (DOR)		Up to approximately 5 years
Secondary	Time To Progression (TTP)		Up to approximately 5 years
Secondary	Time To Next Treatment (TTNT)		Up to approximately 5 years
Secondary	Progression-free Survival 2 (PFS-2)		Up to approximately 5 years
Secondary	Minimal Residual Disease (MRD) Negativity Rate		Up to approximately 5 years
Secondary	Number Of Participants With Adverse Events (AEs)		Up to approximately 5 years
Secondary	Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	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
Secondary	Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	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

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