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NCT06615479PHASE3Recruiting

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)

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

Start Date

3/12/2025

Completion Date

6/22/2032

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986393

DRUG

Cyclophosphamide

DRUG

Fludarabine

DRUG

Daratumumab

DRUG

Pomalidomide

DRUG

Dexamethasone

DRUG

Carfilzomib

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Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35205

United States

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California 90404

United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Orange, California 92868

United States

Local Institution - 0223

Washington D.C., District of Columbia 20007

United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida 32207

United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida 33136

United States

Local Institution - 0228

Orlando, Florida 32804

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana 71103

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Local Institution - 0219

Minneapolis, Minnesota 55455

United States

Weill Cornell Medical College

New York, New York 10065

United States

Local Institution - 0221

Stony Brook, New York 11794

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

Local Institution - 0232

Pittsburgh, Pennsylvania 15224

United States

Local Institution - 0227

Charleston, South Carolina 29425

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D. C1199ABB

Argentina

Local Institution - 0214

ABB, Buenos Aires F.D. C1199ABB

Argentina

Hospital Aleman

Buenos Aires, Buenos Aires F.D. C1118AAT

Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

Princess Alexandra Hospital

Brisbane, Queensland 4102

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Monash Health

Clayton, Victoria 3168

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150

Australia

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria 4020

Austria

Hanusch-Krankenhaus

Vienna, 1140

Austria

Antwerp University Hospital

Edegem, Antwerpen 2650

Belgium

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de 1200

Belgium

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

Yvoir, Namur 5530

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

Local Institution - 0012

Nova Lima, Minas Gerais 34000-000

Brazil

A. C. Camargo Cancer Center

São Paulo, São Paulo 01509-010

Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, 01401-002

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Vancouver General Hospital

Vancouver, British Columbia V5Z 1M9

Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia B3H 2Y9

Canada

Local Institution - 0192

Hamilton, Ontario L8V5C2

Canada

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec H1T 2M4

Canada

Fakultní nemocnice Brno Bohunice

Brno, Brno-město 625 00

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové 500 05

Czechia

Fakultni nemocnice Ostrava

Ostrava, Moravian-Silesian Region 708 52

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808

Czechia

Rigshospitalet

Copenhagen, Capital Region 2100

Denmark

Aarhus Universitetshospital, Skejby

Aarhus, Central Jutland 8200

Denmark

Roskilde Sygehus

Roskilde, Region Sjælland 4000

Denmark

Odense Universitetshospital

Odense, Region Syddanmark 5000

Denmark

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

Helsinki, Uusimaa 00029

Finland

Oulun yliopistollinen sairaala

Oulu, 90220

Finland

Turku University Hospital

Turku, 20251

Finland

Hopital Claude Huriez - CHU de Lille

Lille, Nord 59000

France

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

Nantes, Pays de la Loire Region 44000

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhône 69310

France

Henri Mondor Hospital

Créteil, Val-de-Marne 94010

France

Hôpital Saint-Louis

Paris, 75010

France

TUM Klinikum

Munich, Bavaria 81675

Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony 30625

Germany

Klinikum Chemnitz - Flemmingstraße

Chemnitz, Saxony 09116

Germany

Universitätsklinikum Leipzig

Leipzig, Saxony 04103

Germany

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt 39120

Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein 24105

Germany

Charité Campus Virchow-Klinikum

Berlin, 13353

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Universitaetsklinikum Heidelberg

Heidelberg, D-69120

Germany

Klinikum Nuernberg Nord

Nuremberg, 90419

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97080

Germany

University Hospital of Patras

Pátrai, Achaḯa 26504

Greece

Evangelismos General Hospital of Athens

Athens, Attikí 106 76

Greece

Attikon General University Hospital

Chaïdári, Attikí 12462

Greece

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar 4032

Hungary

Local Institution - 0125

Budapest, 1097

Hungary

Sheba Medical Center

Ramat Gan, Central District 5262100

Israel

Hadassah Medical Center

Jerusalem, Jerusalem 9112001

Israel

Sourasky Medical Center

Tel Aviv, Tell Abīb 6423906

Israel

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy 20133

Italy

Istituto Clinico Humanitas

Rozzano, Milano 20089

Italy

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

Turin, Piedmont 10126

Italy

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

Bologna, 40138

Italy

IRCCS AOM Azienda Ospedaliera Metropolitana

Genova, 16132

Italy

P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100

Italy

Nagoya City University Hospital

Nagoya, Aichi-ken 467-8602

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo 663-8501

Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken 920-8641

Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo 150-8935

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka Red Cross Hospital

Osaka, 543-8555

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

Radboudumc

Nijmegen, Gelderland 6525 GA

Netherlands

Maastricht UMC+

Maastricht, Limburg 6229 HX

Netherlands

Amsterdam UMC, locatie VUmc

Amsterdam, North Holland 1081 HV

Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX

Netherlands

Sykehusapoteket Ull

Oslo, 0450

Norway

Centrum Onkologii Ziemi Lubelskiej

Lublin, Lublin Voivodeship 20-090

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship 80-214

Poland

Local Institution - 0084

Katowice, 40-519

Poland

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

Lodz, Łódź Voivodeship 93-513

Poland

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072

Portugal

Fundeni Clinical Institute

Bucharest, Bucharest 022328

Romania

Spitalul Universitar de Urgență București

Bucharest, 050098

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Local Institution - 0178

Riyadh, 12713

Saudi Arabia

National University Hospital

Singapore, Central Singapore 119074

Singapore

Local Institution - 0181

Singapore, Central Singapore 169608

Singapore

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul] 03080

South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 06351

South Korea

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

Seoul, Seoul-teukbyeolsi [Seoul] 06591

South Korea

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Hospital Universitari Son Espases

Palma, Balears [Baleares] 07120

Spain

Institut Catalan d Oncologia (ICO) - Badalona

Badalona, Barcelona [Barcelona] 08916

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Virgen Nieves

Granada, 18012

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007

Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14] 413 45

Sweden

Karolinska Universitetssjukhuset Huddinge

Huddinge, 141 86

Sweden

Skånes Universitetssjukhus Lund

Lund, 222 42

Sweden

Inselspital Bern

Bern, Canton of Bern 3010

Switzerland

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen 9007

Switzerland

National Taiwan University Cancer Center (NTUCC)

Taipei City, Taipei 106

Taiwan

China Medical University Hospital

Taichung, 404332

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, 06200

Turkey (Türkiye)

Addenbrooke's Hospital

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

University College London Hospital

London, London, City of NW1 2PG

United Kingdom

Churchill Hospital

Oxford, Oxfordshire OX3 7LE

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF

United Kingdom