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Search / Trial NCT05519085

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

Launched by CELGENE · Aug 25, 2022

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Multiple Myeloma Rrmm Mezi Vd P Vd Cc92480 Pomalidomide Bortezomib Dexamethasone Mezigdomide

ClinConnect Summary

This clinical trial is investigating a new treatment combination for patients with relapsed or refractory multiple myeloma (RRMM), which means their cancer has returned or did not respond to previous therapies. The study is comparing two treatment groups: one group will receive mezigdomide, bortezomib, and dexamethasone (called MEZIVd), while the other group will receive pomalidomide, bortezomib, and dexamethasone (called PVd). The goal is to see which combination is more effective and safer for patients who have already tried one to three previous treatments and have experienced some level of benefit from those treatments.

To be eligible for this study, participants must have a confirmed diagnosis of multiple myeloma and measurable disease, meaning that the disease can be tracked with specific tests. They should have received one to three prior therapies and should have had at least a minimal response to one of those treatments. Patients who have had recent progression during or shortly after certain treatments or those who have previously used the drugs being tested may not qualify. If you choose to participate, you will be closely monitored throughout the study, and your health will be regularly assessed to evaluate how well the treatment is working.

Gender

ALL

Eligibility criteria

  • 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 frequently) are not excluded.
  • ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment 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.

About Celgene

Celgene, now a part of Bristol Myers Squibb, is a global biopharmaceutical company dedicated to advancing innovative therapies for patients with cancer and other serious diseases. With a strong emphasis on research and development, Celgene focuses on discovering and delivering transformative medicines that address unmet medical needs. The company is committed to enhancing patient outcomes through rigorous clinical trials, cutting-edge science, and collaboration with healthcare professionals, ultimately striving to improve the quality of life for patients worldwide.

Locations

Kansas City, Kansas, United States

Ann Arbor, Michigan, United States

Iowa City, Iowa, United States

Detroit, Michigan, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Liverpool, New South Wales, Australia

Madrid, , Spain

Rochester, New York, United States

New Orleans, Louisiana, United States

San Diego, California, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Box Hill, Victoria, Australia

Boston, Massachusetts, United States

Murcia, , Spain

Cleveland, Ohio, United States

Seattle, Washington, United States

New Haven, Connecticut, United States

London, , United Kingdom

Nedlands, Western Australia, Australia

Houston, Texas, United States

Norfolk, Virginia, United States

Buffalo, New York, United States

Madison, Wisconsin, United States

Seattle, Washington, United States

Salt Lake City, Utah, United States

Melbourne, Victoria, Australia

Beijing, Beijing, China

Minneapolis, Minnesota, United States

Vancouver, Washington, United States

Antwerpen, , Belgium

Tuebingen, , Germany

Seoul, , Korea, Republic Of

Westwood, Kansas, United States

Barcelona, , Spain

Shijiazhuang, Hebei, China

Leicester, Leicestershire, United Kingdom

London, , United Kingdom

Kashiwa, Chiba, Japan

Sapporo, Hokkaido, Japan

Melbourne, Victoria, Australia

Waratah, New South Wales, Australia

Cincinnati, Ohio, United States

Athens, Georgia, United States

Cambridge, Cambridgeshire, United Kingdom

Kiel, , Germany

Bonn, Nordrhein Westfalen, Germany

Nantes, , France

Albuquerque, New Mexico, United States

Wien, , Austria

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Busan, , Korea, Republic Of

Auckland, , New Zealand

Tuebingen, , Germany

Tokyo, , Japan

Bonn, , Germany

Marburg, , Germany

Seoul, , Korea, Republic Of

Paris, , France

Wels, , Austria

Pavia, , Italy

Garden City, Kansas, United States

Guangzhou, , China

Linz, , Austria

Guangzhou, Guangdong, China

Chiba, , Japan

Seoul, , Korea, Republic Of

Changsha, Hunan, China

Madurai, Tamil Nadu, India

Allentown, Pennsylvania, United States

Kumamoto, , Japan

Buenos Aires, , Argentina

Fukuoka, , Japan

Melbourne, , Australia

Newcastle Upon Tyne, , United Kingdom

Bucharest, , Romania

Aachen, , Germany

Lille, , France

Wuhan, Hubei, China

Kamakura, Kanagawa, Japan

Beijing, , China

Wuxi, Jiangsu, China

Shenyang, Liaoning, China

Marbella, Málaga, Spain

Nanjing, Jiangsu, China

Marbella, , Spain

Beijing, Beijing, China

Seongnam, , Korea, Republic Of

Cáceres, , Spain

Shenzhen, Guangdong, China

Ann Arbor, Michigan, United States

Tianjin, Tianjin, China

Bamberg, , Germany

Wroclaw, , Poland

Roanoke, Virginia, United States

Saint Petersburg, Florida, United States

Tokyo, , Japan

Iasi, , Romania

Cáceres, , Spain

Changsha, Hunan, China

Busan, , Korea, Republic Of

Roma, , Italy

Hattiesburg, Mississippi, United States

Linhai, Zhejiang, China

Shijiazhuang, , China

Luoyang, Henan, China

Prague, , Czechia

Stoke On Trent, , United Kingdom

Seoul, , Korea, Republic Of

Hattiesburg, Mississippi, United States

Bronx, New York, United States

Puducherry, , India

Istanbul, , Turkey

Xiamen, Fujian, China

Braga, , Portugal

Birtinya, Queensland, Australia

Greenfield Park, Quebec, Canada

Fredericksburg, Virginia, United States

Kunming, Yunnan, China

Ningbo, Zhejiang, China

Tel Aviv, , Israel

Nanjing, Jiangsu, China

Gent, Oost Vlaanderen, Belgium

Dunedin, Otago, New Zealand

Athens, Georgia, United States

Limoges, , France

Xi'an, Shaanxi, China

London, London, City Of, United Kingdom

Qingdao, Shandong, China

Truro, England, United Kingdom

Barnet, , United Kingdom

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

West Palm Beach, Florida, United States

Farmington, Connecticut, United States

Katowice, , Poland

Porto, , Portugal

Koshigaya, Saitama, Japan

Athens, , Greece

San Antonio, Texas, United States

Zhengzhou, Henan, China

Seongnam, Kyǒnggi Do, Korea, Republic Of

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Fort Myers, Florida, United States

St. Pölten, , Austria

Los Alamitos, California, United States

Marietta, Georgia, United States

East Brunswick, New Jersey, United States

Fukuoka, , Japan

San Antonio, Texas, United States

Taiyuan, Shanxi, China

Warsaw, , Poland

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Jaú, São Paulo, Brazil

St. Pölten, , Austria

Mayfield Heights, Ohio, United States

Ramat Gan, Hamerkaz, Israel

York, Pennsylvania, United States

Kfar Saba, Hamerkaz, Israel

Tamarac, Florida, United States

Athens, , Greece

Ludhiana, , India

Pittsburgh, Pennsylvania, United States

Viedma, Río Negro, Argentina

Thessaloniki, Thessaloníki, Greece

Nantes, , France

Hamburg, , Germany

Praha, , Czechia

Palma, , Spain

Tucson, Arizona, United States

Brno, Brno Město, Czechia

Tauranga, Bay Of Plenty, New Zealand

Torun, Kujawsko Pomorskie, Poland

Haifa, Hatsafon, Israel

Xi'an, Shaanxi, China

Ramat Gan, Hamerkaz, Israel

Strasbourg, Alsace, France

Kiel, Schleswig Holstein, Germany

Helsinki, , Finland

Lille, Nord, France

Athens, Attikí, Greece

Athens, Attikí, Greece

Catania, Sicilia, Italy

Shiwa Gun Yahaba Cho, Iwate, Japan

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Tel Aviv, Tell Abīb, Israel

Palma, Balears [Baleares], Spain

Barcelona, Catalunya [Cataluña], Spain

Madrid, Madrid, Comunidad De, Spain

Helsinki, Uusimaa, Finland

Paris, île De France, France

Lisbon, , Portugal

Melbourne, Victoria, Australia

Quebec City, Quebec, Canada

Ankara, , Turkey

Seoul, Seodaemun Gu, Korea, Republic Of

Porto Alegre, Rio Grande Do Sul, Brazil

Cáceres, Extremadura, Spain

Samsun, , Turkey

Fayetteville, Arkansas, United States

Spokane, Washington, United States

Cordoba, Córdoba, Argentina

Santa Fe, , Argentina

Krems An Der Donau, , Austria

Leoben, , Austria

Greenfield Park, Quebec, Canada

Xiamen, Fujian, China

Nanning, Guangxi, China

Clermont Ferrand, , France

Rennes Cedex 02, , France

Paris, île De France, France

Hwasun, , Korea, Republic Of

Seongnam, , Korea, Republic Of

Chorzów, , Poland

Gdansk, , Poland

Lublin, , Poland

Barcelona, Catalunya [Cataluña], Spain

Ankara, , Turkey

Istanbul, , Turkey

İzmir, , Turkey

Kayseri, , Turkey

Samsun, , Turkey

Belagavi, Karnataka, India

Jackson, Mississippi, United States

Limerick, , Ireland

Warsaw, Mazowieckie, Poland

Warsaw, Mazowieckie, Poland

Palma, Balears [Baleares], Spain

Marbella, Málaga, Spain

Hwasun, Jeonranamdo, Korea, Republic Of

Cork, , Ireland

Lake Success, New York, United States

Germantown, Tennessee, United States

Viedma, Río Negro, Argentina

Rosario, Santa Fe, Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Box Hill, Victoria, Australia

Gent, Oost Vlaanderen, Belgium

Quebec City, Quebec, Canada

Beijing, Beijing, China

Shenzhen, Guangdong, China

Nanjing, Jiangsu, China

Kunming, Yunnan, China

Shijiazhuang, , China

Kuopio, Pohjois Savo, Finland

Strasbourg, Alsace, France

Pessac, Aquitaine, France

Lyon Cedex 08, Rhône Alpes, France

Nîmes, , France

Tours, , France

Rome, Roma, Italy

Torun, Kujawsko Pomorskie, Poland

Palma, Illes Balears, Spain

Barcelona, , Spain

Truro, England, United Kingdom

Stoke On Trent, , United Kingdom

Barcelona, Catalunya [Cataluña], Spain

Santa Fe, , Argentina

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Pessac, Aquitaine, France

York, Pennsylvania, United States

Clermont Ferrand, , France

Nagaizumi Cho,Sunto Gun, Shizuoka, Japan

New York, New York, United States

Saint Louis, Missouri, United States

Catania, Sicilia, Italy

Bologna, , Italy

Kuopio, Pohjois Savo, Finland

Beijing City, Beijing, China

Lake Success, New York, United States

Lyon Cedex08, Rhône Alpes, France

Vienna, Wien, Austria

West Hollywood, California, United States

Nîmes, Gard, France

Williamsville, New York, United States

Montreal, Quebec, Canada

Nîmes, Gard, France

Lyon Cedex08, Rhône Alpes, France

Tours, , France

Liverpool, New South Wales, Australia

Nowra, New South Wales, Australia

Waratah, New South Wales, Australia

Melbourne, Victoria, Australia

Nedlands, Western Australia, Australia

Lyon, Rhône Alpes, France

Bologna, , Italy

Lisbon, Lisboa, Portugal

Słupsk, Pomorskie, Poland

Shenyang, Liaoning, China

Sao Paulo, , Brazil

Porto, , Portugal

Baton Rouge, Louisiana, United States

Meldola, Emilia Romagna, Italy

Joinville, Santa Catarina, Brazil

Jaú, São Paulo, Brazil

Barnet, , United Kingdom

Chivilcoy, Buenos Aires, Argentina

Kashiwa, Chiba, Japan

Tokyo, , Japan

Kitakyushu Shi, Fukuoka, Japan

Sapporo, Hokkaido, Japan

Chiba, , Japan

Fukuoka, , Japan

Hiroshima, , Japan

Kumamoto, , Japan

Tokyo, , Japan

Rome, Roma, Italy

Nagasaki, , Japan

Salvador, Bahia, Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

Rio De Janeiro, , Brazil

Sao Paulo, , Brazil

Shiwa Gun Yahaba Cho, Iwate, Japan

Kamakura, Kanagawa, Japan

Iruma, Saitama, Japan

Koshigaya, Saitama, Japan

Nagaizumi Cho,Sunto Gun, Shizuoka, Japan

Itabashiku, Tokyo, Japan

Fukuoka, , Japan

Seoul, , Korea, Republic Of

Sint Niklaas, Oost Vlaanderen, Belgium

Kansas City, Kansas, United States

Galway, Connaught, Ireland

Dublin, , Ireland

Marietta, Georgia, United States

Rochester, New York, United States

Spokane, Washington, United States

Buenos Aires, , Argentina

Vienna, Wien, Austria

Krems An Der Donau, , Austria

Leoben, , Austria

St. Pölten, , Austria

Wien, , Austria

Sint Niklaas, Oost Vlaanderen, Belgium

Antwerpen, , Belgium

Genk, , Belgium

Sao Paulo, , Brazil

Beijing City, Beijing, China

Beijing, Beijing, China

Beijing, Beijing, China

Chongqing, Chongqing, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Zhengzhou, Henan, China

Wuhan, Hubei, China

Changsha, Hunan, China

Changsha, Hunan, China

Wuxi, Jiangsu, China

Xi'an, Shaanxi, China

Xi'an, Shaanxi, China

Qingdao, Shandong, China

Shanghai, Shanghai, China

Taiyuan, Shanxi, China

Tianjin, Tianjin, China

Hangzhou, Zhejiang, China

Ningbo, Zhejiang, China

Wenzhou, Zhejiang, China

Taiyuan, , China

Brno, Brno Město, Czechia

Ostrava, Ostrava Město, Czechia

Praha, , Czechia

Helsinki, , Finland

Marburg, Hessen, Germany

Bonn, Nordrhein Westfalen, Germany

Kiel, Schleswig Holstein, Germany

Hamburg, , Germany

Tuebingen, , Germany

Athens, Attikí, Greece

Athens, Attikí, Greece

Thessaloniki, Thessaloníki, Greece

Galway, Connaught, Ireland

Cork, , Ireland

Dublin, , Ireland

Kfar Saba, Hamerkaz, Israel

Ramat Gan, Hamerkaz, Israel

Haifa, Hatsafon, Israel

Tel Aviv, Tall Abīb, Israel

Jerusalem, Yerushalayim, Israel

Peatch Tikva, , Israel

Busan, Busan Gwangyeoksi, Korea, Republic Of

Busan, Busan Gwangyeoksi, Korea, Republic Of

Seongnam, Gyeonggido, Korea, Republic Of

Seongnam, Gyeonggido, Korea, Republic Of

Hwasun, Jeonranamdo, Korea, Republic Of

Hwasun, Jeonranamdo, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teukbyeolsi, Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Braga, , Portugal

Lisbon, , Portugal

Bucharest, , Romania

Cluj Napoca, , Romania

Iasi, , Romania

Palma, Illes Balears, Spain

Murcia, Murcia, Región De, Spain

Marbella, Málaga, Spain

León, , Spain

Madrid, , Spain

Airdrie, Great Britain, United Kingdom

Leicester, Leicestershire, United Kingdom

London, London, City Of, United Kingdom

Newcastle Upon Tyne, , United Kingdom

Genk, Limburg, Belgium

Antwerpen, , Belgium

Chongqing, Chongqing, China

Birtinya, Queensland, Australia

Kraków, Małopolskie, Poland

Shirley, New York, United States

Buenos Aires, , Argentina

Cambridge, England, United Kingdom

Santiago, Región Metropolitana De Santiago, Chile

Ankara, , Turkey

Cambridge, Cambridgeshire, United Kingdom

Viña Del Mar, Valparaíso, Chile

New Hyde Park, New York, United States

Santa Fe De La Vera Cruz, Santa Fe, Argentina

Cluj Napoca, , Romania

Cordoba, Córdoba, Argentina

Rosario, Santa Fe, Argentina

Buenos Aires, , Argentina

Kitakyushu Shi, Fukuoka, Japan

Nagasaki, , Japan

Słupsk, Pomorskie, Poland

Warsaw, , Poland

Ankara, , Turkey

İzmir, , Turkey

Kayseri, , Turkey

Beijing City, Beijing, China

Wollongong, New South Wales, Australia

Krems An Der Donau, , Austria

Wenzhou, Zhejiang, China

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Tauranga, Bay Of Plenty, New Zealand

Dunedin, Otago, New Zealand

Auckland, , New Zealand

Ankara, , Turkey

Sao Paulo, , Brazil

Ahmedabad, Gujarat, India

Gurugram, Haryana, India

Belagavi, Karnataka, India

Madurai, Tamil Nadu, India

Varanasi, Uttar Pradesh, India

Ludhiana, , India

Jerusalem, Yerushalayim, Israel

Itabashiku, Tokyo, Japan

Hiroshima, , Japan

León, , Spain

Cambridge, Cambridgeshire, United Kingdom

Marburg, Hessen, Germany

Puducherry, , India

Hamburg, , Germany

Santiago, Región Metropolitana De Santiago, Chile

Joinville, Santa Catarina, Brazil

Rio De Janeiro, , Brazil

Koshigaya, Saitama, Japan

Poznan, Wielkopolskie, Poland

Airdrie, Great Britain, United Kingdom

Murcia, Murcia, Región De, Spain

Montreal, Quebec, Canada

Shanghai, Shanghai, China

Shanghai, Shanghai, China

Urumqi, Xinjiang, China

Linhai, Zhejiang, China

Iruma, Saitama, Japan

San Juan, , Puerto Rico

Baton Rouge, Louisiana, United States

Baltimore, Maryland, United States

Santiago, Región Metropolitana De Santiago, Chile

Deyang, Sichuan, China

San Diego, California, United States

Boston, Massachusetts, United States

Jackson, Mississippi, United States

Albuquerque, New Mexico, United States

Buffalo, New York, United States

Lake Success, New York, United States

Williamsville, New York, United States

Durham, North Carolina, United States

San Antonio, Texas, United States

Seattle, Washington, United States

Madison, Wisconsin, United States

Leoben, , Austria

Salvador, Bahia, Brazil

Guangzhou, Guangdong, China

Nanning, Guangxi, China

Taiyuan, , China

Tel Aviv, Tall Abīb, Israel

Peatch Tikva, , Israel

Los Alamitos, California, United States

Ridgewood, New Jersey, United States

Allentown, Pennsylvania, United States

Viña Del Mar, Valparaíso, Chile

Warsaw, Mazowieckie, Poland

Skórzewo, Wielkopolskie, Poland

Chivilcoy, Buenos Aires, Argentina

York, Pennsylvania, United States

London, London, City Of, United Kingdom

Katowice, , Poland

Prague, , Czechia

Farmington, Connecticut, United States

Detroit, Michigan, United States

Bronx, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

Shirley, New York, United States

Cleveland, Ohio, United States

Mayfield Heights, Ohio, United States

Jau, São Paulo, Brazil

Shanghai, Shanghai, China

Auckland, , New Zealand

Abilene, Texas, United States

Aurora, Colorado, United States

Shreveport, Louisiana, United States

Meldola, Emilia Romagna, Italy

München, Bayern, Germany

Weiden, Bayern, Germany

Aachen, , Germany

Bamberg, , Germany

Hamburg, , Germany

Coral Springs, Florida, United States

Santiago, Región Metropolitana De Santiago, Chile

Würzburg, , Germany

Fort Myers, Florida, United States

Saint Petersburg, Florida, United States

West Palm Beach, Florida, United States

Cincinnati, Ohio, United States

Roanoke, Virginia, United States

Traunstein, Bayern, Germany

Erfurt, Thüringen, Germany

Luoyang, Henan, China

Dresden, , Germany

Norfolk, Virginia, United States

Cordoba, , Argentina

Minneapolis, Minnesota, United States

San Antonio, Texas, United States

Vancouver, Washington, United States

Pretoria, Gauteng, South Africa

Cape Town, Western Cape, South Africa

Kuilsriver, Western Cape, South Africa

Plumstead, Western Cape, South Africa

Samsun, , Turkey

Abilene, Texas, United States

Ahmedabad, Gujarat, India

Ankara, , Turkey

Abilene, Texas, United States

Liuzhou, Guangxi, China

Weiden, Bayern, Germany

Traunstein, Bayern, Germany

Dresden, , Germany

Würzburg, , Germany

Shanghai, Shanghai, China

Nîmes, , France

Centurion, Gp, South Africa

München, Bayern, Germany

Gurugram, Haryana, India

New Haven, Connecticut, United States

Hannover, Niedersachsen, Germany

Düsseldorf, Nordrhein Westfalen, Germany

Garden City, Kansas, United States

Jau, , Brazil

Thessaloniki, , Greece

Brno, , Czechia

Viedma, , Argentina

Santiago, , Chile

Santiago, , Chile

Viña Del Mar, , Chile

Lyon Cedex08, , France

Erfurt, , Germany

Kraków, , Poland

Barcelona, , Spain

Marbella, , Spain

Mumbai, Maharashtra, India

Liuzhou, Guangxi, China

München, Bayern, Germany

Kuilsriver, Western Cape, South Africa

Patients applied

0 patients applied

Trial Officials

Bristol-Myers Squibb

Study Director

Bristol-Myers Squibb

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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