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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)
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2025-03-12
Completion Date
2032-06-22
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
BMS-986393
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Fludarabine
Specified dose on specified days
Daratumumab
Specified dose on specified days
Pomalidomide
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Locations (141)
University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
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
Weill Cornell Medical College
New York, New York, United States
Local Institution - 0221
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution - 0097
Philadelphia, Pennsylvania, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States
Local Institution - 0227
Charleston, South Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Medical College of Wisconsin
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
Local Institution - 0142
Camperdown, New South Wales, Australia
Local Institution - 0190
Liverpool, New South Wales, Australia
Local Institution - 0140
Brisbane, Queensland, Australia
Local Institution - 0139
Adelaide, South Australia, Australia
Local Institution - 0143
Clayton, Victoria, Australia
Local Institution - 0138
Melbourne, Victoria, Australia
Local Institution - 0191
Melbourne, Victoria, Australia
Local Institution - 0141
Murdoch, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Hanusch-Krankenhaus
Vienna, Austria
Antwerp University Hospital
Edegem, Antwerpen, Belgium
Cliniques universitaires Saint-Luc
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
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Rigshospitalet
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark
Roskilde Sygehus
Køge, 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
IRCCS AOM Azienda Ospedaliera Metropolitana
Genova, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
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
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 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
Yamagata University Hospital
Yamagata, Japan
Radboudumc
Nijmegen, Gelderland, Netherlands