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Search / Trial NCT06615479

A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)

Launched by JUNO THERAPEUTICS, INC., A BRISTOL-MYERS SQUIBB COMPANY · Sep 24, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Relapsed Or Refractory Multiple Myeloma Multiple Myeloma Bms 986393 Chimeric Antigen Receptor T Cell (Car T Cell) Car T Cell Therapy Arlocabtagene Autoleucel Arlo Cel

ClinConnect Summary

This clinical trial, called QUINTESSENTIAL-2, is testing a new treatment called BMS-986393 to see how well it works compared to standard treatments for adults with relapsed or refractory multiple myeloma (a type of blood cancer). Specifically, the study focuses on patients whose disease has not responded to lenalidomide, a common medication for multiple myeloma. The trial is currently looking for participants aged 65 to 74 who have had at least one but no more than three previous treatments and have measurable signs of their disease.

If you or someone you know is eligible, participants can expect to receive either the new treatment or one of the standard therapies and will be closely monitored for how well the treatment works and any side effects. It's important to note that participants should not have certain serious conditions, such as active brain involvement from cancer, and should not need urgent treatment for rapidly worsening disease. This study aims to provide valuable information that could help improve future treatment options for patients with multiple myeloma.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Participants must have relapsed or refractory multiple myeloma (RRMM).
  • Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.
  • Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
  • Participants must have measurable disease during screening.
  • Participants must have adequate organ function.
  • Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.
  • Exclusion Criteria
  • Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
  • Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
  • Participants must not need urgent treatment due to rapidly progressing MM.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

About Juno Therapeutics, Inc., A Bristol Myers Squibb Company

Juno Therapeutics, Inc., a Bristol-Myers Squibb company, is a biopharmaceutical organization dedicated to advancing innovative cell therapies for the treatment of cancer. With a strong focus on harnessing the power of the immune system, Juno is at the forefront of developing cutting-edge therapies, including CAR T-cell and TCR therapies, aimed at addressing unmet medical needs in hematologic malignancies and solid tumors. As a leader in the field of immuno-oncology, Juno Therapeutics combines rigorous scientific research with a commitment to patient-centric solutions, striving to improve outcomes for patients battling cancer worldwide.

Locations

Philadelphia, Pennsylvania, United States

Adelaide, South Australia, Australia

Vancouver, British Columbia, Canada

Camperdown, New South Wales, Australia

Atlanta, Georgia, United States

Wuerzburg, , Germany

Fukuoka, , Japan

Yamagata, , Japan

Hamburg, , Germany

Kumamoto, , Japan

Hannover, Niedersachsen, Germany

Patras, , Greece

Leipzig, Sachsen, Germany

Melbourne, Victoria, Australia

Osaka, , Japan

Tokyo, , Japan

Manchester, , United Kingdom

Nagoya, Aichi, Japan

Okayama, , Japan

Utrecht, , Netherlands

Rozzano, Milano, Italy

Pamplona, Navarra, Spain

Buenos Aires, , Argentina

Pierre Bénite, , France

Huddinge, , Sweden

Tel Aviv, , Israel

Gent, Oost Vlaanderen, Belgium

Clayton, Victoria, Australia

Jerusalem, Yerushalayim, Israel

Praha 2, , Czechia

Porto, , Portugal

Athens, , Greece

Vienna, , Austria

Linz, , Austria

Bucuresti, , Romania

Linz, Oberösterreich, Austria

Copenhagen, Hovedstaden, Denmark

St.Gallen, Sankt Gallen, Switzerland

Salamanca, , Spain

Aarhus, Midtjylland, Denmark

Ramat Gan, Hamerkaz, Israel

Odense, Syddanmark, Denmark

Brno, Brno Město, Czechia

Oslo, , Norway

Gdańsk, Pomorskie, Poland

Patras, Achaḯa, Greece

Lille, Nord, France

Athens, Attikí, Greece

Tel Aviv, Tell Abīb, Israel

Los Angeles, California, United States

Helsinki, Uusimaa, Finland

Nishinomiya, Hyogo, Japan

Newcastle Upon Tyne, , United Kingdom

Hradec Kralove, , Czechia

Heidelberg, , Germany

Montreal, Quebec, Canada

Santiago De Compostela, , Spain

Bern, Berne, Switzerland

Lublin, Lubelskie, Poland

Lille, Nord, France

Iași, , Romania

Bucuresti, București, Romania

Birmingham, Alabama, United States

Los Angeles, California, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Westwood, Kansas, United States

Baltimore, Maryland, United States

New York, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Salt Lake City, Utah, United States

Madison, Wisconsin, United States

Abb, Ciudad Autónoma De Buenos Aires, Argentina

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Camperdown, New South Wales, Australia

Brisbane, Queensland, Australia

Adelaide, South Australia, Australia

Clayton, Victoria, Australia

Melbourne, Victoria, Australia

Murdoch, Western Australia, Australia

Linz, Oberösterreich, Austria

Vienna, , Austria

Yvoir, Namur, Belgium

Gent, Oost Vlaanderen, Belgium

Gent, Oost Vlaanderen, Belgium

Belo Horizonte, Minas Gerais, Brazil

São Paulo, Sao Paulo, Brazil

Sao Paulo, São Paulo, Brazil

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

Montreal, Quebec, Canada

Brno, Brno Město, Czechia

Praha 2, , Czechia

Copenhagen, Hovedstaden, Denmark

Aarhus, Midtjylland, Denmark

Odense, Syddanmark, Denmark

Helsinki, Uusimaa, Finland

Creteil, Val De Marne, France

Leipzig, Sachsen, Germany

Heidelberg, , Germany

Wuerzburg, , Germany

Wuerzburg, , Germany

Patras, Achaḯa, Greece

Athens, Attikí, Greece

Chaidari, Attikí, Greece

Budapest, , Hungary

Debrecen, , Hungary

Ramat Gan, Hamerkaz, Israel

Tel Aviv, Tell Abīb, Israel

Jerusalem, Yerushalayim, Israel

Milan, Lombardia, Italy

Rozzano, Milano, Italy

Torino, Piemonte, Italy

Bologna, , Italy

Nagoya, Aichi, Japan

Kashiwa, Chiba, Japan

Nishinomiya, Hyogo, Japan

Kanazawa, Ishikawa, Japan

Fukuoka, , Japan

Kumamoto, , Japan

Okayama, , Japan

Osaka, , Japan

Tokyo, , Japan

Yamagata, , Japan

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

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

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

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

Nijmegen, Gelderland, Netherlands

Maastricht, Limburg, Netherlands

Amsterdam, Noord Holland, Netherlands

Groningen, , Netherlands

Utrecht, , Netherlands

Utrecht, , Netherlands

Oslo, , Norway

Gdańsk, Pomorskie, Poland

Katowice, , Poland

Lublin, , Poland

Porto, , Portugal

Bucuresti, București, Romania

Iași, , Romania

Riyadh, , Saudi Arabia

Singapore, Central Singapore, Singapore

Singapore, Central Singapore, Singapore

Santiago De Compostela, A Coruña [La Coruña], Spain

Pamplona, Navarra, Spain

Salamanca, , Spain

Huddinge, , Sweden

St.Gallen, Sankt Gallen, Switzerland

Taipei City, Taipei, Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Ankara, , Turkey

Cambridge, Cambridgeshire, United Kingdom

Cambridge, England, United Kingdom

London, London, City Of, United Kingdom

Oxford, Oxfordshire, United Kingdom

Manchester, , United Kingdom

Manchester, , United Kingdom

Charlotte, North Carolina, United States

Nova Lima, Minas Gerais, Brazil

München, Bayern, Germany

Nürnberg, Bayern, Germany

Hamburg, , Germany

Hannover, , Germany

łódź, łódzkie, Poland

São Paulo, , Brazil

Hamilton, Ontario, Canada

Pierre Bénite, Rhône, France

Liverpool, New South Wales, Australia

Melbourne, Victoria, Australia

Cleveland, Ohio, United States

Boston, Massachusetts, United States

Milwaukee, Wisconsin, United States

Hradec Kralove, Hradec Králové, Czechia

Genova, , Italy

Udine, , Italy

Lublin, Lubelskie, Poland

Palma, Balears [Baleares], Spain

Badalona, Barcelona [Barcelona], Spain

Granada, , Spain

Roskilde, Sjælland, Denmark

Nantes, Pays De La Loire, France

Chemnitz, Sachsen, Germany

Bern, Berne, Switzerland

Taipei, , Taiwan

Abb, Ciudad Autónoma De Buenos Aires, Argentina

Paris, , France

Munich, Bayern, Germany

Magdeburg, Sachsen Anhalt, Germany

Kiel, Schleswig Holstein, Germany

Berlin, , Germany

Winston Salem, North Carolina, United States

Brussels, Bruxelles Capitale, Région De, Belgium

Nuremberg, , Germany

Lund, , Sweden

Brno, , Czechia

Abb, , Argentina

Abb, , Argentina

Abb, , Argentina

Buenos Aires, , Argentina

Brussels, , Belgium

Sao Paulo, , Brazil

Roskilde, , Denmark

Pierre Bénite, , France

Chaidari, , Greece

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

łódź, , Poland

Santiago De Compostela, , Spain

Palma, , Spain

Badalona, , Spain

Lund, , Sweden

London, , United Kingdom

Edegem, Antwerpen, Belgium

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