RecruitingPhase 3NCT06615479

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)

A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma


Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Enrollment

440 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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.

Interventions

DRUGBMS-986393

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

DRUGFludarabine

Specified dose on specified days

DRUGDaratumumab

Specified dose on specified days

DRUGPomalidomide

Specified dose on specified days

DRUGDexamethasone

Specified dose on specified days

DRUGCarfilzomib

Specified dose on specified days


Locations(138)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California, United States

Local Institution - 0050

Orange, California, United States

Local Institution - 0223

Washington D.C., District of Columbia, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Local Institution - 0130

Miami, Florida, United States

Local Institution - 0228

Orlando, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Local Institution - 0219

Minneapolis, Minnesota, United States

Local Institution - 0229

New York, New York, United States

Local Institution - 0221

Stony Brook, New York, United States

Local Institution - 0067

Charlotte, North Carolina, United States

Local Institution - 0216

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Local Institution - 0232

Pittsburgh, Pennsylvania, United States

Local Institution - 0227

Charleston, South Carolina, United States

Local Institution - 0184

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Local Institution - 0195

Milwaukee, Wisconsin, United States

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Local Institution - 0214

ABB, Buenos Aires F.D., Argentina

Hospital Aleman

Buenos Aires, Buenos Aires F.D., Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Hanusch-Krankenhaus

Vienna, Austria

Antwerp University Hospital

Edegem, Antwerpen, Belgium

Local Institution - 0217

Brussels, Bruxelles-Capitale, Région de, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

Yvoir, Namur, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0012

Nova Lima, Minas Gerais, Brazil

A. C. Camargo Cancer Center

São Paulo, São Paulo, Brazil

Local Institution - 0103

São Paulo, São Paulo, Brazil

Local Institution - 0031

São Paulo, Brazil

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, Canada

Local Institution - 0192

Hamilton, Ontario, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Fakultní nemocnice Brno Bohunice

Brno, Brno-město, Czechia

Local Institution - 0093

Hradec Králové, Hradec Králové, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Rigshospitalet

Copenhagen, Capital Region, Denmark

Aarhus Universitetshospital, Skejby

Aarhus, Central Jutland, Denmark

Roskilde Sygehus

Roskilde, Region Sjælland, Denmark

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

Helsinki, Uusimaa, Finland

Oulun yliopistollinen sairaala

Oulu, Finland

Turku University Hospital

Turku, Finland

Hopital Claude Huriez - CHU de Lille

Lille, Nord, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, Pays de la Loire Region, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhône, France

Henri Mondor Hospital

Créteil, Val-de-Marne, France

Hôpital Saint-Louis

Paris, France

TUM Klinikum

Munich, Bavaria, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Klinikum Chemnitz - Flemmingstraße

Chemnitz, Saxony, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany

Charité Campus Virchow-Klinikum

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Klinikum Nuernberg Nord

Nuremberg, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

University Hospital of Patras

Pátrai, Achaḯa, Greece

Evangelismos General Hospital of Athens

Athens, Attikí, Greece

Attikon General University Hospital

Chaïdári, Attikí, Greece

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, Hungary

Local Institution - 0125

Budapest, Hungary

Sheba Medical Center

Ramat Gan, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, Italy

Ospedale San Martino

Genova, Italy

Local Institution - 0106

Udine, Italy

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kyushu University Hospital

Fukuoka, Japan

Kumamoto University Hospital

Kumamoto, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Red Cross Hospital

Osaka, Japan

Japanese Red Cross Medical Center

Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan

Radboudumc

Nijmegen, Gelderland, Netherlands

Maastricht UMC+

Maastricht, Limburg, Netherlands

Amsterdam UMC, locatie VUmc

Amsterdam, North Holland, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Sykehusapoteket Ull

Oslo, Norway

Centrum Onkologii Ziemi Lubelskiej

Lublin, Lublin Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0084

Katowice, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, Łódź Voivodeship, Poland

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Fundeni Clinical Institute

Bucharest, București, Romania

Institutul Regional de Oncologie

Iași, Romania

Local Institution - 0178

Riyadh, Saudi Arabia

National University Hospital

Singapore, Central Singapore, Singapore

Local Institution - 0181

Singapore, Central Singapore, Singapore

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

CHUS - Hospital Clinico Universitario

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

Hospital Universitari Son Espases

Palma, Balears [Baleares], Spain

Institut Catalan d Oncologia (ICO) - Badalona

Badalona, Barcelona [Barcelona], Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Virgen Nieves

Granada, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], Sweden

Karolinska Universitetssjukhuset Huddinge

Huddinge, Sweden

Skånes Universitetssjukhus Lund

Lund, Sweden

Inselspital Bern

Bern, Canton of Bern, Switzerland

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

National Taiwan University Cancer Center (NTUCC)

Taipei City, Taipei, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Local Institution - 0200

Taipei, Taiwan

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, Turkey (Türkiye)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

University College London Hospital

London, London, City of, United Kingdom

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06615479


Related Trials