What this study is
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.
What's being tested
- BMS-986393
Intervention · DRUG
- Cyclophosphamide
Intervention · DRUG
- Fludarabine
Intervention · DRUG
- Daratumumab
Intervention · DRUG
- Pomalidomide
Intervention · DRUG
- Dexamethasone
Intervention · DRUG
- Carfilzomib
Intervention · DRUG
All interventions
Specified dose on specified days
Study details
- 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
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)
- Enrolling
- 440 people
- Starts
- 2025-03-12
- Est. completion
- 2032-06-22
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (141)
124 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Susan Bal, Site 0071 · Contact205-934-1908
RecruitingUCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
- Sarah Larson, Site 0032 · Contact310-829-5471
RecruitingUniversity of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
- Stefan Ciurea, Site 0050 · Contact714-509-2290
RecruitingGeorgetown University Medical Center
Washington D.C., District of Columbia, United States
- Kimberley Doucette, Site 0223 · Contact202-444-1953
RecruitingBaptist MD Anderson Cancer Center
Jacksonville, Florida, United States
- Maxim Norkin, Site 0231 · Contact248-756-4524
RecruitingUniversity of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
- Damian Green, Site 0130 · Contact000-000-0000
RecruitingWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
- Nisha Joseph, Site 0058 · Contact502-608-5503
RecruitingLouisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States
- Shashank Cingam, Site 0218 · Contact505-272-4946
RecruitingBoston Medical Center
Boston, Massachusetts, United States
- Raphael Szalat, Site 0196 · Contact617-638-6428
RecruitingWeill Cornell Medical College
New York, New York, United States
- Mateo Mejia Saldarriaga, Site 0229 · Contact646-962-6500
RecruitingLevine Cancer Institute
Charlotte, North Carolina, United States
- Barry Paul, Site 0216 · Contact704-942-5953
RecruitingLevine Cancer Institute
Charlotte, North Carolina, United States
- Barry Paul, Site 0067 · Contact704-942-5953
Recruiting- Recruiting
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States
- Santhosh Sadashiv, Site 0232 · Contact412-578-4484
RecruitingUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
- Oren Pasvolsky, Site 0184 · Contact832-728-1403
RecruitingHuntsman Cancer Institute
Salt Lake City, Utah, United States
- Brian McClune, Site 0044 · Contact801-213-8480
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Othman Akhtar, Site 0195 · Contact
RecruitingLocal Institution - 0228
Orlando, Florida, United States
WithdrawnLocal Institution - 0219
Minneapolis, Minnesota, United States
WithdrawnLocal Institution - 0221
Stony Brook, New York, United States
WithdrawnLocal Institution - 0097
Philadelphia, Pennsylvania, United States
Active, not recruitingLocal Institution - 0227
Charleston, South Carolina, United States
Withdrawn
119 sites outside the US
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
- Natalia Schutz, Site 0122 · Contact5491126742365
RecruitingHospital Aleman
Buenos Aires, Buenos Aires F.D., Argentina
- Gonzalo Garate, Site 0121 · Contact+5491153857234
RecruitingOrdensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
- Irene Strassl, Site 0167 · Contact+004373276764411
Recruiting- Recruiting
Antwerp University Hospital
Edegem, Antwerpen, Belgium
- Sebastien Anguille, Site 0220 · Contact003238215398
RecruitingCliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium
- Marie-Christiane Vekemans, Site 0217 · Contact3227641800
RecruitingUniversité Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, Namur, Belgium
- Gilles CROCHET, Site 0162 · Contact+328142.3838
Recruiting- Recruiting
Local Institution - 0012
Nova Lima, Minas Gerais, Brazil
- Site 0012 · Contact
Not yet recruitingA. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
- Jayr Schmidt Filho, Site 0013 · Contact+5511953790662
RecruitingInstituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, Brazil
- Eduardo Rego, Site 0103 · Contact
RecruitingSociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
- Mariana Kerbauy, Site 0031 · Contact+5511995470026
RecruitingArthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
- Nizar Bahlis, Site 0069 · Contact4032202801
RecruitingVancouver General Hospital
Vancouver, British Columbia, Canada
- Hannah Cherniawsky, Site 0003 · Contact6048754863
RecruitingQEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada
- Darrell White, Site 0004 · Contact9024734642
RecruitingHamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, Canada
- Hira Mian, Site 0192 · Contact9053879495
RecruitingCIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
- Richard LeBlanc, Site 0001 · Contact1-514-252-3404
RecruitingFakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
- Ludek Pour, Site 0094 · Contact+420532233551
RecruitingFakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
- Jakub Radocha, Site 0093 · Contact420495834522
RecruitingFakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, Czechia
- Jana Mihalyova, Site 0095 · Contact597372094
Recruiting- Recruiting
- Recruiting
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark
- Maja Vase, Site 0020 · Contact4521423108
Recruiting- Recruiting
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
- Ida Kristensen, Site 0022 · Contact+4524775611
RecruitingHelsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, Finland
- Mikko Keranen, Site 0026 · Contact+358 94 711
Recruiting- Recruiting
- Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
- Salomon Manier, Site 0081 · Contact33320444292
RecruitingCentre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, France
- Cyrille Touzeau, Site 0194 · Contact33240083271
RecruitingCentre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
- Lionel Karlin, Site 0080 · Contact33478864309
RecruitingHenri Mondor Hospital
Créteil, Val-de-Marne, France
- Karim BELHADJ-MERZOUG, Site 0079 · Contact+33149812163
Recruiting- Recruiting
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
- Annamaria Brioli, Site 0186 · Contact+490511532-3020
RecruitingKlinikum Chemnitz - Flemmingstraße
Chemnitz, Saxony, Germany
- Mathias Haenel, Site 0204 · Contact4937133344500
Recruiting- Recruiting
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
- Dimitrios Mougiakakos, Site 0211 · Contact49-391-67-21233
RecruitingUniversitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany
- Natalie Schub, Site 0212 · Contact+4943150022711
Recruiting- Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
- Katja Weisel, Site 0188 · Contact4970712989200
RecruitingUniversitaetsklinikum Heidelberg
Heidelberg, Germany
- Marc-Steffen Raab, Site 0165 · Contact496221565427
Recruiting- Recruiting
- Recruiting
University Hospital of Patras
Pátrai, Achaḯa, Greece
- Alexandros Spyridonidis, Site 0111 · Contact306977448977
RecruitingEvangelismos General Hospital of Athens
Athens, Attikí, Greece
- Ioannis Baltadakis, Site 0117 · Contact+306974359426
RecruitingAttikon General University Hospital
Chaïdári, Attikí, Greece
- Evangelos Terpos, Site 0115 · Contact00306937437111
RecruitingDebreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, Hungary
- Arpad Illes, Site 0124 · Contact36303263397
Recruiting- Recruiting
- Recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
- Paolo Corradini, Site 0107 · Contact+390223902950
Recruiting- Recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
- Francesca Gay, Site 0128 · Contact+390116336107
RecruitingIRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Italy
- Elena Zamagni, Site 0108 · Contact
RecruitingIRCCS AOM Azienda Ospedaliera Metropolitana
Genova, Italy
- EMANUELE ANGELUCCI, Site 0119 · Contact+390105553651
RecruitingP.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
- FRANCESCA PATRIARCA, Site 0106 · Contact0432559618
Recruiting- Recruiting
- Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
- Satoshi Yoshihara, Site 0087 · Contact0087
RecruitingKanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
- Hiroyuki Takamatsu, Site 0104 · Contact0104
Recruiting- Recruiting
- Recruiting
- Recruiting
National Hospital Organization Okayama Medical Center
Okayama, Japan
- YASUHISA Sando, Site 0090 · Contact0090
Recruiting- Recruiting
- Recruiting
- Recruiting
Maastricht UMC+
Maastricht, Limburg, Netherlands
- Janine Van Elssen, Site 0163 · Contact
RecruitingAmsterdam UMC, locatie VUmc
Amsterdam, North Holland, Netherlands
- Sonja Zweegman, Site 0179 · Contact+31(0)204442604
RecruitingUniversitair Medisch Centrum Utrecht
Utrecht, Netherlands
- Rimke Oostvogels, Site 0171 · Contact+318875555555
Recruiting- Recruiting
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lublin Voivodeship, Poland
- Wojciech Legiec, Site 0092 · Contact48502074194
RecruitingUniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
- Jan Zaucha, Site 0083 · Contact+48509219986
RecruitingLocal Institution - 0084
Katowice, Poland
- Site 0084 · Contact
Not yet recruitingWojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland
- Agnieszka Wierzbowska, Site 0183 · Contact+486895486
RecruitingInstituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
- Jose Mariz, Site 0137 · Contact351225084000
Recruiting- Recruiting
Spitalul Universitar de Urgență București
Bucharest, Romania
- Horia Bumbea, Site 0207 · Contact0040213180522
Recruiting- Recruiting
National University Hospital
Singapore, Central Singapore, Singapore
- Esther Chan, Site 0180 · Contact6567722724
RecruitingSeoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- YOUNGIL KOH, Site 0147 · Contact01091175012
RecruitingAsan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Dok Hyun Yoon, Site 0146 · Contact82230105940
RecruitingSamsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Kihyun Kim, Site 0148 · Contact+821099333456
RecruitingThe Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Chang Ki Min, Site 0149 · Contact82-20-2258-6053
RecruitingCHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], Spain
- Marta Sonia GOnzalez Perez, Site 0136 · Contact+34616869283
RecruitingHospital Universitari Son Espases
Palma, Balears [Baleares], Spain
- Antonia Sampol Mayol, Site 0203 · Contact34871206268
RecruitingInstitut Catalan d Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], Spain
- Laura Abril Sabater, Site 0201 · Contact34934978387
RecruitingClinica Universidad de Navarra
Pamplona, Navarre, Spain
- Paula Rodriguez Otero, Site 0135 · Contact+0034948254000 0 000
RecruitingHospital Universitario Virgen Nieves
Granada, Spain
- Esther Clavero Sánchez, Site 0202 · Contact0034958020013
RecruitingHospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
- Maria Victoria Mateos Manteca, Site 0134 · Contact34923291100
RecruitingSahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], Sweden
- Markus Hansson, Site 0025 · Contact46 31- 342 11 40
RecruitingKarolinska Universitetssjukhuset Huddinge
Huddinge, Sweden
- Johan Törlén, Site 0027 · Contact+46(0)812385880
Recruiting- Recruiting
Inselspital Bern
Bern, Canton of Bern, Switzerland
- Martina Bertschinger, Site 0205 · Contact
RecruitingCantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
- ILIAS STAGAKIS, Site 0168 · Contact+41714941157
RecruitingNational Taiwan University Cancer Center (NTUCC)
Taipei City, Taipei, Taiwan
- Bor-Sheng Ko, Site 0150 · Contact88622312345663576
Recruiting- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
- Shang-Yi Huang, Site 0152 · Contact886223123456X63575
Recruiting- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, Turkey (Türkiye)
- Fevzi Altuntas, Site 0170 · Contact903123360909-7215
RecruitingAddenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
- Faisal Basheer, Site 0182 · Contact01223596275
RecruitingUniversity College London Hospital
London, London, City of, United Kingdom
- Rakesh Popat, Site 0155 · Contact020 3456 7890
RecruitingChurchill Hospital
Oxford, Oxfordshire, United Kingdom
- Jaimal Kothari, Site 0157 · Contact0300 304 7777
RecruitingThe Christie NHS Foundation Trust
Manchester, United Kingdom
- Ahmed Abdulgawad, Site 0174 · Contact+441614463054
Recruiting- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
- Elisa Roldan Galvan, Site 0206 · Contact07977969791
RecruitingLocal Institution - 0214
ABB, Buenos Aires F.D., Argentina
WithdrawnLocal Institution - 0142
Camperdown, New South Wales, Australia
Active, not recruitingLocal Institution - 0190
Liverpool, New South Wales, Australia
Active, not recruitingLocal Institution - 0140
Brisbane, Queensland, Australia
Active, not recruitingLocal Institution - 0139
Adelaide, South Australia, Australia
Active, not recruitingLocal Institution - 0143
Clayton, Victoria, Australia
Active, not recruitingLocal Institution - 0138
Melbourne, Victoria, Australia
Active, not recruitingLocal Institution - 0191
Melbourne, Victoria, Australia
Active, not recruitingLocal Institution - 0141
Murdoch, Western Australia, Australia
Active, not recruitingLocal Institution - 0125
Budapest, Hungary
WithdrawnLocal Institution - 0178
Riyadh, Saudi Arabia
WithdrawnLocal Institution - 0181
Singapore, Central Singapore, Singapore
Withdrawn
Study team
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID CA088-1007
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.