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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
2026-03-17
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 (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