Relapsed or Refractory Multiple Myeloma (RRMM)Phase 3NCT06615479
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)
A Phase 3 study testing BMS-986393, Cyclophosphamide and Fludarabine in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 141 sites in 31 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- BMS-986393, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 141 sitesin 31 countries
- Study dates
- 12 Mar 2025to 22 Jun 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
141 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
141 sites in 31 countries
United States22 sites, 17 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Nisha Joseph, Site 0058, 502-608-5503
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Susan Bal, Site 0071, 205-934-1908
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Raphael Szalat, Site 0196, 617-638-6428
- Withdrawn
Local Institution - 0227
Charleston, South Carolina, 29425
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Barry Paul, Site 0216, 704-942-5953
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Barry Paul, Site 0067, 704-942-5953
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sandra Mazzoni, Site 0193, 216-445-2025
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Oren Pasvolsky, Site 0184, 832-728-1403
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Maxim Norkin, Site 0231, 248-756-4524
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
Sarah Larson, Site 0032, 310-829-5471
- Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Damian Green, Site 0130, 000-000-0000
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Othman Akhtar, Site 0195
- Withdrawn
Local Institution - 0219
Minneapolis, Minnesota, 55455
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Mateo Mejia Saldarriaga, Site 0229, 646-962-6500
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Stefan Ciurea, Site 0050, 714-509-2290
- Withdrawn
Local Institution - 0228
Orlando, Florida, 32804
- Active, not recruiting
Local Institution - 0097
Philadelphia, Pennsylvania, 19111
- Recruiting
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Santhosh Sadashiv, Site 0232, 412-578-4484
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Brian McClune, Site 0044, 801-213-8480
- Recruiting
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103
Shashank Cingam, Site 0218, 505-272-4946
- Withdrawn
Local Institution - 0221
Stony Brook, New York, 11794
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Kimberley Doucette, Site 0223, 202-444-1953
Germany11 sites, 11 recruiting
- Recruiting
Charité Campus Virchow-Klinikum
Berlin, 13353
Olaf Penack, Site 0213, 4930450653625
- Recruiting
Klinikum Chemnitz - Flemmingstraße
Chemnitz, Saxony, 09116
Mathias Haenel, Site 0204, 4937133344500
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Katja Weisel, Site 0188, 4970712989200
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Annamaria Brioli, Site 0186, +490511532-3020
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, D-69120
Marc-Steffen Raab, Site 0165, 496221565427
- Recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105
Natalie Schub, Site 0212, +4943150022711
- Recruiting
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Vladan Vucinic, Site 0164, 493419713841
- Recruiting
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Dimitrios Mougiakakos, Site 0211, 49-391-67-21233
- Recruiting
TUM Klinikum
Munich, Bavaria, 81675
Judith Hecker, Site 0185, +498941405968
- Recruiting
Klinikum Nuernberg Nord
Nuremberg, 90419
Stefan Knop, Site 0187, +499113983050
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Martin Kortuem, Site 0169, 004993120140001
Japan10 sites, 10 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
Kohta Miyawaki, Site 0089, 0089
- Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Hiroyuki Takamatsu, Site 0104, 0104
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Junichiro Yuda, Site 0105, 0105
- Recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
Yawara Kawano, Site 0102, 0102
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Masaki Ri, Site 0098, 0098
- Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Satoshi Yoshihara, Site 0087, 0087
- Recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
YASUHISA Sando, Site 0090, 0090
- Recruiting
Osaka Red Cross Hospital
Osaka, 543-8555
Kazunori Imada, Site 0099, 0099
- Recruiting
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935
Tadao Ishida, Site 0091, 0091
- Recruiting
Yamagata University Hospital
Yamagata, 990-9585
Satoshi Ito, Site 0100, 0100
Australia8 sites, 8 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Cindy Lee, Site 0139, +61 08 7074 3290
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Fiona Swain, Site 0140, 0731762111
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Joy Ho, Site 0142, +61295158031
- Recruiting
Monash Health
Clayton, Victoria, 3168
Danielle Oh, Site 0143, 03 9594 4044
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Adam Bryant, Site 0190, 0287385167
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Amit Khot, Site 0138, 61385595000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Sueh-Li Lim, Site 0191, 0403374221
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Stephanie Lam, Site 0141, +61861523788
Italy6 sites, 6 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Elena Zamagni, Site 0108
- Recruiting
IRCCS AOM Azienda Ospedaliera Metropolitana
Genova, 16132
EMANUELE ANGELUCCI, Site 0119, +390105553651
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Paolo Corradini, Site 0107, +390223902950
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Stefania Bramanti, Site 0109, +390282247755
- Recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
Francesca Gay, Site 0128, +390116336107
- Recruiting
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
FRANCESCA PATRIARCA, Site 0106, 0432559618
Spain6 sites, 6 recruiting
- Recruiting
Institut Catalan d Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], 08916
Laura Abril Sabater, Site 0201, 34934978387
- Recruiting
Hospital Universitario Virgen Nieves
Granada, 18012
Esther Clavero Sánchez, Site 0202, 0034958020013
- Recruiting
Hospital Universitari Son Espases
Palma, Balears [Baleares], 07120
Antonia Sampol Mayol, Site 0203, 34871206268
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Paula Rodriguez Otero, Site 0135, +0034948254000 0 000
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Maria Victoria Mateos Manteca, Site 0134, 34923291100
- Recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], 15706
Marta Sonia GOnzalez Perez, Site 0136, +34616869283
United Kingdom6 sites, 6 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ
Faisal Basheer, Site 0182, 01223596275
- Recruiting
University College London Hospital
London, London, City of, NW1 2PG
Rakesh Popat, Site 0155, 020 3456 7890
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Ahmed Abdulgawad, Site 0174, +441614463054
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Thomas Creasey, Site 0154, 01912336161
- Recruiting
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
Jaimal Kothari, Site 0157, 0300 304 7777
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Elisa Roldan Galvan, Site 0206, 07977969791
Canada5 sites, 5 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Nizar Bahlis, Site 0069, 4032202801
- Recruiting
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, B3H 2Y9
Darrell White, Site 0004, 9024734642
- Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, L8V5C2
Hira Mian, Site 0192, 9053879495
- Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
Richard LeBlanc, Site 0001, 1-514-252-3404
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Hannah Cherniawsky, Site 0003, 6048754863
France5 sites, 5 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, Val-de-Marne, 94010
Karim BELHADJ-MERZOUG, Site 0079, +33149812163
- Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59000
Salomon Manier, Site 0081, 33320444292
- Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, 44000
Cyrille Touzeau, Site 0194, 33240083271
- Recruiting
Hôpital Saint-Louis
Paris, 75010
Bertrand Arnulf, Site 0210, 33142499472
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310
Lionel Karlin, Site 0080, 33478864309
Belgium4 sites, 4 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, 1200
Marie-Christiane Vekemans, Site 0217, 3227641800
- Recruiting
Antwerp University Hospital
Edegem, Antwerpen, 2650
Sebastien Anguille, Site 0220, 003238215398
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Nicolas Kint, Site 0175, 093324912
- Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, Namur, 5530
Gilles CROCHET, Site 0162, +328142.3838
Brazil4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0012
Nova Lima, Minas Gerais, 34000-000
Site 0012
- Recruiting
A. C. Camargo Cancer Center
São Paulo, São Paulo, 01509-010
Jayr Schmidt Filho, Site 0013, +5511953790662
- Recruiting
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 01401-002
Eduardo Rego, Site 0103
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
Mariana Kerbauy, Site 0031, +5511995470026
Czechia4 sites, 4 recruiting
- Recruiting
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, 625 00
Ludek Pour, Site 0094, +420532233551
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05
Jakub Radocha, Site 0093, 420495834522
- Recruiting
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jana Mihalyova, Site 0095, 597372094
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Jan Straub, Site 0129, +420604483698
Denmark4 sites, 4 recruiting
- Recruiting
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200
Maja Vase, Site 0020, 4521423108
- Recruiting
Rigshospitalet
Copenhagen, Capital Region, 2100
Anne Mylin, Site 0019, +4535452850
- Recruiting
Odense Universitetshospital
Odense, Region Syddanmark, 5000
Ida Kristensen, Site 0022, +4524775611
- Recruiting
Roskilde Sygehus
Roskilde, Region Sjælland, 4000
Nicolai Jørgensen, Site 0208, 4547324956
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HV
Sonja Zweegman, Site 0179, +31(0)204442604
- Recruiting
Maastricht UMC+
Maastricht, Limburg, 6229 HX
Janine Van Elssen, Site 0163
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Elizabeth De Kort, Site 0176, +31243614794
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Rimke Oostvogels, Site 0171, +318875555555
Poland4 sites, 4 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214
Jan Zaucha, Site 0083, +48509219986
- Not yet recruiting
Local Institution - 0084
Katowice, 40-519
Site 0084
- Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, 93-513
Agnieszka Wierzbowska, Site 0183, +486895486
- Recruiting
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lublin Voivodeship, 20-090
Wojciech Legiec, Site 0092, 48502074194
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
YOUNGIL KOH, Site 0147, 01091175012
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Dok Hyun Yoon, Site 0146, 82230105940
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Kihyun Kim, Site 0148, +821099333456
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Chang Ki Min, Site 0149, 82-20-2258-6053
Taiwan4 sites, 4 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404332
Su-Peng Yeh, Site 0151, 886975680836
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Shang-Yi Huang, Site 0152, 886223123456X63575
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Chia-Jen Liu, Site 0200, +886-2-28757529
- Recruiting
National Taiwan University Cancer Center (NTUCC)
Taipei City, Taipei, 106
Bor-Sheng Ko, Site 0150, 88622312345663576
Argentina3 sites, 2 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Natalia Schutz, Site 0122, 5491126742365
- Withdrawn
Local Institution - 0214
ABB, Buenos Aires F.D., C1199ABB
- Recruiting
Hospital Aleman
Buenos Aires, Buenos Aires F.D., C1118AAT
Gonzalo Garate, Site 0121, +5491153857234
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, 00029
Mikko Keranen, Site 0026, +358 94 711
- Recruiting
Oulun yliopistollinen sairaala
Oulu, 90220
Marjaana Saily, Site 0018, +358 407 196 754
- Recruiting
Turku University Hospital
Turku, 20251
Juha Ranti, Site 0021, +358 407 196 754
Greece3 sites, 3 recruiting
- Recruiting
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76
Ioannis Baltadakis, Site 0117, +306974359426
- Recruiting
Attikon General University Hospital
Chaïdári, Attikí, 12462
Evangelos Terpos, Site 0115, 00306937437111
- Recruiting
University Hospital of Patras
Pátrai, Achaḯa, 26504
Alexandros Spyridonidis, Site 0111, 306977448977
Israel3 sites, 3 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Eyal Lebel, Site 0116, 972-50-5172304
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5262100
Hila Magen, Site 0112, 972504065462
- Recruiting
Sourasky Medical Center
Tel Aviv, Tell Abīb, 6423906
Ron Ram, Site 0118, 97236974138
Romania3 sites, 3 recruiting
- Recruiting
Fundeni Clinical Institute
Bucharest, Bucharest, 022328
Alina Tanase, Site 0173, 40784219942
- Recruiting
Spitalul Universitar de Urgență București
Bucharest, 050098
Horia Bumbea, Site 0207, 0040213180522
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Angela Dascalescu, Site 0172, 40740157774
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], 413 45
Markus Hansson, Site 0025, 46 31- 342 11 40
- Recruiting
Karolinska Universitetssjukhuset Huddinge
Huddinge, 141 86
Johan Törlén, Site 0027, +46(0)812385880
- Recruiting
Skånes Universitetssjukhus Lund
Lund, 222 42
Stina Wichert, Site 0023, +46 46 171 000
Austria2 sites, 2 recruiting
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
Irene Strassl, Site 0167, +004373276764411
- Recruiting
Hanusch-Krankenhaus
Vienna, 1140
Felix Keil, Site 0166, 004319102157300
Hungary2 sites, 1 recruiting
- Withdrawn
Local Institution - 0125
Budapest, 1097
- Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4032
Arpad Illes, Site 0124, 36303263397
Singapore2 sites, 1 recruiting
- Recruiting
National University Hospital
Singapore, Central Singapore, 119074
Esther Chan, Site 0180, 6567722724
- Withdrawn
Local Institution - 0181
Singapore, Central Singapore, 169608
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital Bern
Bern, Canton of Bern, 3010
Martina Bertschinger, Site 0205
- Recruiting
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
ILIAS STAGAKIS, Site 0168, +41714941157
Norway1 site, 1 recruiting
- Recruiting
Sykehusapoteket Ull
Oslo, 0450
Ingerid Abrahamsen, Site 0016, +4723070460
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Jose Mariz, Site 0137, 351225084000
Saudi Arabia1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0178
Riyadh, 12713
Site 0178
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200
Fevzi Altuntas, Site 0170, 903123360909-7215
About this study
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
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.
- Being tested
- BMS-986393, Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide
- Keywords
- Relapsed or Refractory Multiple Myeloma, Multiple Myeloma, BMS-986393, Chimeric Antigen Receptor T-cell (CAR T-cell), CAR T-cell Therapy, Arlocabtagene Autoleucel, Arlo-cel
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986393Drug
Also called Arlo-cel
Specified dose on specified days
CyclophosphamideDrug
Specified dose on specified days
FludarabineDrug
Specified dose on specified days
DaratumumabDrug
Specified dose on specified days
PomalidomideDrug
Specified dose on specified days
DexamethasoneDrug
Specified dose on specified days
CarfilzomibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: BMS-986393; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Carfilzomib |
| Arm B | Active comparator | Not described Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Carfilzomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Measured: Up to 1 year after the last participant is randomized
Secondary outcomes (12)
Overall survival (OS)
Measured: Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Measured: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Measured: Up to 5 years after the last participant is randomized
Complete response rate (CRR)
Measured: Up to 5 years after the last participant is randomized
Time to response (TTR)
Measured: Up to 5 years after the last participant is randomized
Duration of response (DOR)
Measured: Up to 5 years after the last participant is randomized
Maximum observed concentration (Cmax) of transgene level
Measured: Up to 5 years after the last participant is randomized
Time of maximum observed plasma concentration (Tmax) of transgene level
Measured: Up to 5 years after the last participant is randomized
Area under the concentration-time curve (AUC) of transgene level
Measured: 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
EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL).
Measured: 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
EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
Measured: Up to 5 years after the last participant is randomized
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
Measured: Up to 5 years after the last participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start12 Mar 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion22 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615479
- Sponsor's protocol ID
- CA088-1007
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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