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)

September 14, 2026 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Natalia Schutz, Site 0122
          • Phone Number: 5491126742365
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Withdrawn
        • Local Institution - 0214
      • Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman
        • Contact:
          • Gonzalo Garate, Site 0121
          • Phone Number: +5491153857234
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Joy Ho, Site 0142
          • Phone Number: +61295158031
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Adam Bryant, Site 0190
          • Phone Number: 0287385167
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Fiona Swain, Site 0140
          • Phone Number: 0731762111
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Cindy Lee, Site 0139
          • Phone Number: +61 08 7074 3290
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Contact:
          • Danielle Oh, Site 0143
          • Phone Number: 03 9594 4044
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Amit Khot, Site 0138
          • Phone Number: 61385595000
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Sueh-Li Lim, Site 0191
          • Phone Number: 0403374221
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Stephanie Lam, Site 0141
          • Phone Number: +61861523788
  • Austria
      • Vienna, Austria, 1140
        • Recruiting
        • Hanusch-Krankenhaus
        • Contact:
          • Felix Keil, Site 0166
          • Phone Number: 004319102157300
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen
        • Contact:
          • Irene Strassl, Site 0167
          • Phone Number: +004373276764411
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Contact:
          • Sebastien Anguille, Site 0220
          • Phone Number: 003238215398
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
          • Marie-Christiane Vekemans, Site 0217
          • Phone Number: 3227641800
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
        • Contact:
          • Gilles CROCHET, Site 0162
          • Phone Number: +328142.3838
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
          • Nicolas Kint, Site 0175
          • Phone Number: 093324912
  • Brazil
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
        • Contact:
          • Mariana Kerbauy, Site 0031
          • Phone Number: +5511995470026
      • São Paulo, Brazil, 01401-002
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino (IDOR)
        • Contact:
          • Eduardo Rego, Site 0103
    • Minas Gerais
      • Nova Lima, Minas Gerais, Brazil, 34000-000
        • Not yet recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center
        • Contact:
          • Jayr Schmidt Filho, Site 0013
          • Phone Number: +5511953790662
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
        • Contact:
          • Nizar Bahlis, Site 0069
          • Phone Number: 4032202801
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
          • Hannah Cherniawsky, Site 0003
          • Phone Number: 6048754863
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site
        • Contact:
          • Darrell White, Site 0004
          • Phone Number: 9024734642
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre
        • Contact:
          • Hira Mian, Site 0192
          • Phone Number: 9053879495
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l'Est-de-l'Ile-de-Montreal
        • Contact:
          • Richard LeBlanc, Site 0001
          • Phone Number: 1-514-252-3404
  • Czechia
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Contact:
          • Jan Straub, Site 0129
          • Phone Number: +420604483698
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Recruiting
        • Fakultní nemocnice Brno Bohunice
        • Contact:
          • Ludek Pour, Site 0094
          • Phone Number: +420532233551
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Contact:
          • Jakub Radocha, Site 0093
          • Phone Number: 420495834522
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • Fakultni Nemocnice Ostrava
        • Contact:
          • Jana Mihalyova, Site 0095
          • Phone Number: 597372094
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Anne Mylin, Site 0019
          • Phone Number: +4535452850
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Contact:
          • Maja Vase, Site 0020
          • Phone Number: 4521423108
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Recruiting
        • Roskilde Sygehus
        • Contact:
          • Nicolai Jørgensen, Site 0208
          • Phone Number: 4547324956
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital
        • Contact:
          • Ida Kristensen, Site 0022
          • Phone Number: +4524775611
  • Finland
      • Oulu, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala
        • Contact:
          • Marjaana Saily, Site 0018
          • Phone Number: +358 407 196 754
      • Turku, Finland, 20251
        • Recruiting
        • Turku University Hospital
        • Contact:
          • Juha Ranti, Site 0021
          • Phone Number: +358 407 196 754
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
        • Contact:
          • Mikko Keranen, Site 0026
          • Phone Number: +358 94 711
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Bertrand Arnulf, Site 0210
          • Phone Number: 33142499472
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Contact:
          • Salomon Manier, Site 0081
          • Phone Number: 33320444292
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Contact:
          • Cyrille Touzeau, Site 0194
          • Phone Number: 33240083271
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Recruiting
        • Centre Hospitalier LYON SUD
        • Contact:
          • Lionel Karlin, Site 0080
          • Phone Number: 33478864309
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Recruiting
        • Henri Mondor Hospital
        • Contact:
          • Karim BELHADJ-MERZOUG, Site 0079
          • Phone Number: +33149812163
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum
        • Contact:
          • Olaf Penack, Site 0213
          • Phone Number: 4930450653625
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Contact:
          • Katja Weisel, Site 0188
          • Phone Number: 4970712989200
      • Heidelberg, Germany, D-69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
        • Contact:
          • Marc-Steffen Raab, Site 0165
          • Phone Number: 496221565427
      • Nuremberg, Germany, 90419
        • Recruiting
        • Klinikum Nuernberg Nord
        • Contact:
          • Stefan Knop, Site 0187
          • Phone Number: +499113983050
      • Würzburg, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Martin Kortuem, Site 0169
          • Phone Number: 004993120140001
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • TUM Klinikum
        • Contact:
          • Judith Hecker, Site 0185
          • Phone Number: +498941405968
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Annamaria Brioli, Site 0186
          • Phone Number: +490511532-3020
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz - Flemmingstraße
        • Contact:
          • Mathias Haenel, Site 0204
          • Phone Number: 4937133344500
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitatsklinikum Leipzig
        • Contact:
          • Vladan Vucinic, Site 0164
          • Phone Number: 493419713841
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Recruiting
        • Universitaetsklinikum Magdeburg
        • Contact:
          • Dimitrios Mougiakakos, Site 0211
          • Phone Number: 49-391-67-21233
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
        • Contact:
          • Natalie Schub, Site 0212
          • Phone Number: +4943150022711
  • Greece
    • Achaḯa
      • Pátrai, Achaḯa, Greece, 26504
        • Recruiting
        • University Hospital of Patras
        • Contact:
          • Alexandros Spyridonidis, Site 0111
          • Phone Number: 306977448977
    • Attikí
      • Athens, Attikí, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens
        • Contact:
          • Ioannis Baltadakis, Site 0117
          • Phone Number: +306974359426
      • Chaïdári, Attikí, Greece, 12462
        • Recruiting
        • Attikon General University Hospital
        • Contact:
          • Evangelos Terpos, Site 0115
          • Phone Number: 00306937437111
  • Hungary
      • Budapest, Hungary, 1097
        • Withdrawn
        • Local Institution - 0125
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
        • Contact:
          • Arpad Illes, Site 0124
          • Phone Number: 36303263397
  • Israel
    • Central District
      • Ramat Gan, Central District, Israel, 5262100
        • Recruiting
        • Sheba medical center
        • Contact:
          • Hila Magen, Site 0112
          • Phone Number: 972504065462
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Eyal Lebel, Site 0116
          • Phone Number: 972-50-5172304
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Ron Ram, Site 0118
          • Phone Number: 97236974138
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Elena Zamagni, Site 0108
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS AOM Azienda Ospedaliera Metropolitana
        • Contact:
          • EMANUELE ANGELUCCI, Site 0119
          • Phone Number: +390105553651
      • Udine, Italy, 33100
        • Recruiting
        • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
        • Contact:
          • FRANCESCA PATRIARCA, Site 0106
          • Phone Number: 0432559618
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Paolo Corradini, Site 0107
          • Phone Number: +390223902950
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
          • Stefania Bramanti, Site 0109
          • Phone Number: +390282247755
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Recruiting
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
        • Contact:
          • Francesca Gay, Site 0128
          • Phone Number: +390116336107
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Kohta Miyawaki, Site 0089
          • Phone Number: 0089
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
        • Contact:
          • Yawara Kawano, Site 0102
          • Phone Number: 0102
      • Okayama, Japan, 701-1192
        • Recruiting
        • National Hospital Organization Okayama Medical Center
        • Contact:
          • YASUHISA Sando, Site 0090
          • Phone Number: 0090
      • Osaka, Japan, 543-8555
        • Recruiting
        • Osaka Red Cross Hospital
        • Contact:
          • Kazunori Imada, Site 0099
          • Phone Number: 0099
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
        • Contact:
          • Satoshi Ito, Site 0100
          • Phone Number: 0100
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
          • Masaki Ri, Site 0098
          • Phone Number: 0098
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • Junichiro Yuda, Site 0105
          • Phone Number: 0105
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital
        • Contact:
          • Satoshi Yoshihara, Site 0087
          • Phone Number: 0087
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
          • Hiroyuki Takamatsu, Site 0104
          • Phone Number: 0104
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 150-8935
        • Recruiting
        • Japanese Red Cross Medical Center
        • Contact:
          • Tadao Ishida, Site 0091
          • Phone Number: 0091
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht
        • Contact:
          • Rimke Oostvogels, Site 0171
          • Phone Number: +318875555555
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc
        • Contact:
          • Elizabeth De Kort, Site 0176
          • Phone Number: +31243614794
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • Janine Van Elssen, Site 0163
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC, locatie VUmc
        • Contact:
          • Sonja Zweegman, Site 0179
          • Phone Number: +31(0)204442604
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Sykehusapoteket Ull
        • Contact:
          • Ingerid Abrahamsen, Site 0016
          • Phone Number: +4723070460
  • Poland
      • Katowice, Poland, 40-519
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej
        • Contact:
          • Wojciech Legiec, Site 0092
          • Phone Number: 48502074194
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Contact:
          • Jan Zaucha, Site 0083
          • Phone Number: +48509219986
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
        • Contact:
          • Agnieszka Wierzbowska, Site 0183
          • Phone Number: +486895486
  • Portugal
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
        • Contact:
          • Jose Mariz, Site 0137
          • Phone Number: 351225084000
  • Romania
      • Bucharest, Romania, 050098
        • Recruiting
        • Spitalul Universitar de Urgenta Bucuresti
        • Contact:
          • Horia Bumbea, Site 0207
          • Phone Number: 0040213180522
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie
        • Contact:
          • Angela Dascalescu, Site 0172
          • Phone Number: 40740157774
    • Bucharest
      • Bucharest, Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute
        • Contact:
          • Alina Tanase, Site 0173
          • Phone Number: 40784219942
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12713
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
          • Esther Chan, Site 0180
          • Phone Number: 6567722724
      • Singapore, Central Singapore, Singapore, 169608
        • Withdrawn
        • Local Institution - 0181
  • South Korea
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • YOUNGIL KOH, Site 0147
          • Phone Number: 01091175012
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Kihyun Kim, Site 0148
          • Phone Number: +821099333456
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Dok Hyun Yoon, Site 0146
          • Phone Number: 82230105940
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Contact:
          • Chang Ki Min, Site 0149
          • Phone Number: 82-20-2258-6053
  • Spain
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario Virgen Nieves
        • Contact:
          • Esther Clavero Sánchez, Site 0202
          • Phone Number: 0034958020013
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Maria Victoria Mateos Manteca, Site 0134
          • Phone Number: 34923291100
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario
        • Contact:
          • Marta Sonia GOnzalez Perez, Site 0136
          • Phone Number: +34616869283
    • Balears [Baleares]
      • Palma, Balears [Baleares], Spain, 07120
        • Recruiting
        • Hospital Universitari Son Espases
        • Contact:
          • Antonia Sampol Mayol, Site 0203
          • Phone Number: 34871206268
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Recruiting
        • Institut Catalan d Oncologia (ICO) - Badalona
        • Contact:
          • Laura Abril Sabater, Site 0201
          • Phone Number: 34934978387
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Paula Rodriguez Otero, Site 0135
          • Phone Number: +0034948254000 0 000
  • Sweden
      • Huddinge, Sweden, 141 86
        • Recruiting
        • Karolinska Universitetssjukhuset Huddinge
        • Contact:
          • Johan Törlén, Site 0027
          • Phone Number: +46(0)812385880
      • Lund, Sweden, 222 42
        • Recruiting
        • Skånes Universitetssjukhus Lund
        • Contact:
          • Stina Wichert, Site 0023
          • Phone Number: +46 46 171 000
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
          • Markus Hansson, Site 0025
          • Phone Number: 46 31- 342 11 40
  • Switzerland
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Contact:
          • Martina Bertschinger, Site 0205
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St.Gallen
        • Contact:
          • ILIAS STAGAKIS, Site 0168
          • Phone Number: +41714941157
  • Taiwan
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Su-Peng Yeh, Site 0151
          • Phone Number: 886975680836
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Shang-Yi Huang, Site 0152
          • Phone Number: 886223123456X63575
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Chia-Jen Liu, Site 0200
          • Phone Number: +886-2-28757529
    • Taipei
      • Taipei City, Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Cancer Center (NTUCC)
        • Contact:
          • Bor-Sheng Ko, Site 0150
          • Phone Number: 88622312345663576
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
        • Contact:
          • Fevzi Altuntas, Site 0170
          • Phone Number: 903123360909-7215
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Ahmed Abdulgawad, Site 0174
          • Phone Number: +441614463054
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital
        • Contact:
          • Thomas Creasey, Site 0154
          • Phone Number: 01912336161
      • Sheffield, United Kingdom, S10 2JF
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Elisa Roldan Galvan, Site 0206
          • Phone Number: 07977969791
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • Faisal Basheer, Site 0182
          • Phone Number: 01223596275
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital
        • Contact:
          • Rakesh Popat, Site 0155
          • Phone Number: 020 3456 7890
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Jaimal Kothari, Site 0157
          • Phone Number: 0300 304 7777
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Susan Bal, Site 0071
          • Phone Number: 205-934-1908
    • California
      • Los Angeles, California, United States, 90404
        • Recruiting
        • UCLA Hematology/Oncology - Santa Monica
        • Contact:
          • Sarah Larson, Site 0032
          • Phone Number: 310-829-5471
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center
        • Contact:
          • Stefan Ciurea, Site 0050
          • Phone Number: 714-509-2290
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
        • Contact:
          • Kimberley Doucette, Site 0223
          • Phone Number: 202-444-1953
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Maxim Norkin, Site 0231
          • Phone Number: 248-756-4524
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center
        • Contact:
          • Damian Green, Site 0130
          • Phone Number: 000-000-0000
      • Orlando, Florida, United States, 32804
        • Withdrawn
        • Local Institution - 0228
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University
        • Contact:
          • Nisha Joseph, Site 0058
          • Phone Number: 502-608-5503
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University Health Sciences Shreveport
        • Contact:
          • Shashank Cingam, Site 0218
          • Phone Number: 505-272-4946
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Raphael Szalat, Site 0196
          • Phone Number: 617-638-6428
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Withdrawn
        • Local Institution - 0219
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical College
        • Contact:
          • Mateo Mejia Saldarriaga, Site 0229
          • Phone Number: 646-962-6500
      • Stony Brook, New York, United States, 11794
        • Withdrawn
        • Local Institution - 0221
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
          • Barry Paul, Site 0067
          • Phone Number: 704-942-5953
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Sandra Mazzoni, Site 0193
          • Phone Number: 216-445-2025
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Local Institution - 0097
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • AHN West Penn Hospital
        • Contact:
          • Santhosh Sadashiv, Site 0232
          • Phone Number: 412-578-4484
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Withdrawn
        • Local Institution - 0227
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Oren Pasvolsky, Site 0184
          • Phone Number: 832-728-1403
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
          • Brian McClune, Site 0044
          • Phone Number: 801-213-8480
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Othman Akhtar, Site 0195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Dexamethasone
Specified dose on specified days
Drug: Pomalidomide
Specified dose on specified days
Drug: Carfilzomib
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: BMS-986393
Specified dose on specified days
Other Names:
  • Arlo-cel
Active Comparator: Arm B
Drug: Dexamethasone
Specified dose on specified days
Drug: Pomalidomide
Specified dose on specified days
Drug: Carfilzomib
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Time Frame: Up to 1 year after the last participant is randomized
Up to 1 year after the last participant is randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Complete response rate (CRR)
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Time to response (TTR)
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Duration of response (DOR)
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Maximum observed concentration (Cmax) of transgene level
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Time of maximum observed plasma concentration (Tmax) of transgene level
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Area under the concentration-time curve (AUC) of transgene level
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized
Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains
Time Frame: Up to 5 years after the last participant is randomized
EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL).
Up to 5 years after the last participant is randomized
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
Time Frame: Up to 5 years after the last participant is randomized
EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
Up to 5 years after the last participant is randomized
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
Time Frame: Up to 5 years after the last participant is randomized
Up to 5 years after the last participant is randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Celgene Corporation

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

June 22, 2032

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA088-1007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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