A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Relapsed or Refractory Multiple Myeloma Clinical Trial

— SUCCESSOR-1  

Official title:

A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519085
• Other study ID #: CA057-001
• Secondary ID: 2021-001957-30
• Status: Recruiting
• Phase: Phase 3
• Start date: September 20, 2022
• Est. completion date: November 30, 2033

Study information

• Verified date: June 2024
• Source: Celgene
• 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 this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: November 30, 2033
• Est. primary completion date: November 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.

i) M-protein = 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.

ii) M-protein = 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).

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

• Participants received 1 to 3 prior lines of antimyeloma therapy.

• Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

Exclusion Criteria

• Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.

i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.

• For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.

• Participant has had prior treatment with mezigdomide or pomalidomide.

• 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
• Pomalidomide
Specified dose on specified days
• Bortezomib
Specified dose on specified days
• Dexamethasone
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Centro Mdico "Barrio Parque"	Buenos Aires
Argentina	Hospital Británico de Buenos Aires	Buenos Aires
Argentina	Sanatorio Chivilcoy	Chivilcoy	Buenos Aires
Argentina	Hospital Privado Universitario de Córdoba	Cordoba	Córdoba
Argentina	Hospital Privado de Rosario	Rosario	Santa Fe
Argentina	Clínica de Nefrología, Urología y Enfermedades Cardiovasculares	Santa Fe
Argentina	Clinica Viedma S. A	Viedma	Río Negro
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Wollongong Hospital-Illawarra Cancer Care Centre	Wollongong	New South Wales
Austria	Universitätsklinikum Krems	Krems an der Donau
Austria	LKH Hochsteiermark - Standort Leoben	Leoben
Austria	Universitätsklinikum St. Pölten	St. Pölten
Austria	Klinik Ottakring	Vienna	Wien
Austria	Hanusch-Krankenhaus	Wien
Belgium	ZNA Cadix	Antwerpen
Belgium	Ziekenhuis Oost-Limburg, Campus St.-Jan	Genk	Limburg
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	AZ Nikolaas	Sint-Niklaas	Oost-Vlaanderen
Brazil	Hospital Amaral Carvalho	Jaú	São Paulo
Brazil	Instituto Joinvilense de Hematologia e Oncologia	Joinville	Santa Catarina
Brazil	Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa	Porto Alegre	Rio Grande Do Sul
Brazil	Americas Centro de Oncologia Integrado	Rio de Janeiro
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador	Salvador	Bahia
Brazil	Clínica Médica São Germano S/S Ltda	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	Sao Paulo
Canada	Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre	Greenfield Park	Quebec
Canada	Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur	Montreal	Quebec
Canada	Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus	Quebec City	Quebec
Chile	Clínica Inmunocel	Santiago	Región Metropolitana De Santiago
Chile	Centro de Investigaciones	Viña del Mar	Valparaíso
China	Local Institution - 0141	Beijing	Beijing
China	Peking University First Hospital	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing City	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing City	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	The First Afffiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Local Institution - 0356	Deyang	Sichuan
China	Henan Cancer Hospital	Guangzhou	Guangdong
China	Local Institution - 0168	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Local Institution - 0151	Hangzhou	Zhejiang
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Local Institution - 0348	Linhai	Zhejiang
China	Local Institution - 0111	Nanjing	Jiangsu
China	Guangxi Medical University No.1 Affiliated Hospital	Nanning	Guangxi
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Local Institution - 0350	Shanghai	Shanghai
China	Shanghai 6th people's hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Local Institution - 0238	Shenzhen	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Bethune Hospital	Taiyuan
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Local Institution - 0353	Urumqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Local Institution - 0110	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'An	Shaanxi
China	The First Affiliated hospital of Xiamen University	Xiamen	Fujian
China	People's Hospital of Henan Province	Zhengzhou	Henan
Czechia	Fakultní nemocnice Brno Bohunice	Brno	Brno-mesto
Czechia	Vseobecna fakultni nemocnice v Praze	Praha
Finland	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)	Helsinki
Finland	Kuopion Yliopistollinen Sairaala	Kuopio	Pohjois-Savo
France	Centre Hospitalier Universitaire Estaing	Clermont-Ferrand
France	Hopital Claude Huriez - CHU de Lille	Lille	Nord
France	Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren	Limoges
France	Centre Leon Berard	Lyon Cedex08	Rhône-Alpes
France	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu	Nantes
France	Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire Carémeau	Nîmes	Gard
France	Hôpital Saint Antoine	Paris	Île-de-France
France	CHU Bordeaux Haut-Leveque	Pessac	Aquitaine
France	Institut de cancérologie Strasbourg Europe (ICANS)	Strasbourg	Alsace
France	Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau	Tours
Germany	Universitätsklinikum Bonn	Bonn	Nordrhein-Westfalen
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Marburg	Marburg	Hessen
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Greece	Alexandra General Hospital of Athens	Athens	Attikí
Greece	Evangelismos General Hospital of Athens	Athens	Attikí
Greece	G. Papanikolaou General Hospital	Thessaloniki	Thessaloníki
India	Local Institution - 0342	Ahmedabad	Gujarat
India	Local Institution - 0336	Belagavi	Karnataka
India	Local Institution - 0338	Gurugram	Haryana
India	Local Institution - 0343	Ludhiana
India	Local Institution - 0344	Madurai	Tamil Nadu
India	Local Institution - 0345	Puducherry
India	Local Institution - 0341	Varanasi	Uttar Pradesh
Ireland	Cork University Hospital	Cork
Ireland	St. James's Hospital	Dublin
Ireland	University College Hospital - Galway	Galway	Connaught
Israel	Rambam Health Care Campus	Haifa	HaTsafon
Israel	Hadassah Medical Center - Do Not Use - Duplicate Facility	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Rabin Medical Center	Peatch Tikva
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Sourasky Medical Center	Tel Aviv	Tall Abib
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola	Bologna
Italy	Policlinico "G. Rodolico"	Catania	Sicilia
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera Sant'Andrea	Roma
Japan	Chiba University Hospital	Chiba
Japan	Japanese Red Cross Fukuoka Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital	Hiroshima
Japan	Saitama Medical University Hospital	Iruma	Saitama
Japan	Nihon University Itabashi Hospital	Itabashiku	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Local Institution - 0281	Kashiwa	Chiba
Japan	Japan Community Healthcare Organization Kyushu Hospital	Kitakyushu-shi	Fukuoka
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya	Saitama
Japan	Kumamoto University	Kumamoto
Japan	Shizuoka Cancer Center	Nagaizumi-cho,Sunto-gun	Shizuoka
Japan	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Iwate Medical University Hospital	Shiwa-gun Yahaba-cho	Iwate
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	The Jikei University Hospital	Tokyo
Korea, Republic of	Local Institution - 0106	Busan	Busan-gwangyeoksi
Korea, Republic of	Pusan National University Hospital	Busan	Busan-gwangyeoksi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonranamdo
Korea, Republic of	Local Institution - 0103	Hwasun	Jeonranamdo
Korea, Republic of	Local Institution - 0102	Seongnam	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution - 0100	Seoul
Korea, Republic of	Local Institution - 0101	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Local Institution - 0104	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Local Institution - 0105	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul Teugbyeolsi
New Zealand	Local Institution - 0334	Auckland
New Zealand	Local Institution - 0340	Dunedin	Otago
New Zealand	Local Institution - 0335	Tauranga	Bay Of Plenty
Poland	Local Institution - 0185	Katowice
Poland	Local Institution - 0325	Kraków	Malopolskie
Poland	Local Institution - 0346	Skórzewo	Wielkopolskie
Poland	Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Slupsku	Slupsk	Pomorskie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Poland	Instytut Hematologii i Transfuzjologii	Warsaw	Mazowieckie
Portugal	Hospital de Braga	Braga
Portugal	Champalimaud Foundation	Lisbon
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE	Porto
Puerto Rico	Local Institution - 0355	San Juan
Romania	Fundeni Clinical Institute	Bucharest
Romania	Institutul Oncologic Cluj	Cluj Napoca
Romania	Institutul Regional de Oncologie Iasi	Iasi
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Local Institution - 0073	Barcelona	Catalunya [Cataluña]
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Complejo Asistencial Universitario de León - Hospital de León	León
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Local Institution - 0182	Marbella	Málaga
Spain	Hospital General Universitario Morales Meseguer	Murcia	Murcia, Región De
Spain	Hospital Universitari Son Espases	Palma	Balears [Baleares]
Spain	Local Institution - 0183	Palma	Illes Balears
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Liv Hospital Ankara	Ankara
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul
Turkey	Ege Universitesi Hastanesi	Izmir
Turkey	Erciyes Universitesi Tip Fakultesi Hastaneleri	Kayseri
Turkey	Ondokuz Mayis Universitesi	Samsun
United Kingdom	Lanarkshire NHS Trust - Monklands Hospital	Airdrie	Great Britain
United Kingdom	Barnet Hospital	Barnet
United Kingdom	Local Institution - 0326	Cambridge	Cambridgeshire
United Kingdom	Leicester Royal Infirmary	Leicester	Leicestershire
United Kingdom	King's College Hospital	London	Greater London
United Kingdom	Local Institution - 0367	London	London, City Of
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent
United Kingdom	The Royal Cornwall Hospital	Truro	England
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	Local Institution - 0359	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	University Cancer Blood Ctr	Athens	Georgia
United States	Local Institution - 0357	Baltimore	Maryland
United States	Local Institution - 0358	Baton Rouge	Louisiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Local Institution - 0245	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke Cancer Institute	Durham	North Carolina
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	Hematology Oncology Associates of Fredericksburg	Fredericksburg	Virginia
United States	Central Care Cancer Center - Garden City	Garden City	Kansas
United States	The West Clinic, PLLC dba West Cancer Center	Germantown	Tennessee
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Local Institution - 0242	Jackson	Mississippi
United States	Northwell Health/ RJ Zuckerberg Cancer Center	Lake Success	New York
United States	Local Institution - 0366	Los Alamitos	California
United States	Local Institution - 0220	Madison	Wisconsin
United States	Local Institution - 0048	Marietta	Georgia
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Local Institution - 0363	Ridgewood	New Jersey
United States	Rochester General Hospital	Rochester	New York
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Mays Cancer Center	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	Local Institution - 0293	Seattle	Washington
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Local Institution - 0097	Spokane	Washington
United States	Advanced Research	Tamarac	Florida
United States	Private Practice - Dr. James R. Berenson	West Hollywood	California
United States	University of Kansas Medical Center	Westwood	Kansas
United States	Local Institution - 0274	Williamsville	New York
United States	Local Institution - 0264	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Finland,  France,  Germany,  Greece,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)		From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)
Secondary	Recommended mezigdomide dose	Stage 1 only	Up to 12 Months
Secondary	Plasma concentrations of mezigdomide	Stage 1 only	Up to 134 Days
Secondary	Overall Survival (OS)		From date of randomization to date of death due to any cause (Up to approximately 5 years)
Secondary	Overall Response (OR)	OR is defined as the number of participants who achieve best response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma	Up to approximately 5 years
Secondary	Complete Response (CR) or better	Defined as the number of participants who achieve best response of complete response (CR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma	Up to approximately 5 Years
Secondary	Very Good Partial Response (VGPR) or better	Defined as the number of participants who achieve best response of very good partial response (VGPR) 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	Defined as the number of participants who achieve complete response (CR) or better and MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells)	Up to approximately 5 years
Secondary	Number of participants with Adverse Events (AEs)		Up to approximately 5 years
Secondary	Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores	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 European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting