Actively Recruiting
A Phase 3, Randomized, Open-Label Study Comparing Arlocabtagene Autoleucel (BMS-986393) Versus Standard Treatments in Adults With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-06-04
440
Participants Needed
140
Research Sites
233 weeks
Total Duration
On this page
Sponsors
J
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead Sponsor
C
Celgene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the safety and effectiveness of arlo-cel (BMS-986393), a CAR-T cell therapy targeting GPRC5D, with standard treatments in adults who have relapsed or refractory multiple myeloma and have been previously treated with lenalidomide. This phase 3 randomized study aims to better understand treatment options for people who have received one to three prior therapies, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. Participants will be randomly assigned to receive either the experimental BMS-986393 therapy or one of the standard regimens, which may involve drugs like cyclophosphamide, fludarabine, daratumumab, pomalidomide, dexamethasone, or carfilzomib. Treatment doses and schedules are specified by the study protocol. The study is open-label and conducted across multiple centers, with follow-up planned for up to five years after the last participant is randomized. During the study, participants will undergo regular evaluations including assessments of progression-free survival, minimal residual disease status, overall survival, and response rates. Quality of life questionnaires will also be used to monitor changes over time. Safety and treatment effects will be monitored throughout the study and during long-term follow-up, which may last up to five years after enrollment ends.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have relapsed or refractory multiple myeloma (RRMM).
- Participants must have received 1 to 3 prior multiple myeloma treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies, with prior lenalidomide exposure.
- Participants must have a confirmed diagnosis of multiple myeloma 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 of 0 or 1.
You will not qualify if you...
- Participants with known active or past central nervous system involvement of multiple myeloma are excluded.
- Participants with solitary plasmacytomas or non-secretory myeloma without measurable disease are excluded.
- Participants needing urgent treatment due to rapidly progressing multiple myeloma are excluded.
- Other protocol-defined inclusion and exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration as specified per treatment protocol
Participants receive specified doses of BMS-986393 or standard drug regimens for relapsed or refractory multiple myeloma.
Visit schedule depends on assigned treatment arm
Duration - Up to 5 years after treatment completion
Participants are monitored for efficacy and safety outcomes including survival and disease response up to 5 years after treatment.
Regular visits scheduled for assessments during follow-up period
Trial Site Locations
Total: 140 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States, 90404
Actively Recruiting
3
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
4
Local Institution - 0223
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
5
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
6
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
Local Institution - 0228
Orlando, Florida, United States, 32803
Not Yet Recruiting
8
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States, 71103
Actively Recruiting
10
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
11
Local Institution - 0219
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
12
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
13
Local Institution - 0221
Stony Brook, New York, United States, 11794
Not Yet Recruiting
14
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
15
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
16
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
17
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
18
Local Institution - 0232
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
19
Local Institution - 0227
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
20
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
22
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
23
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina, C1199ABB
Actively Recruiting
24
Local Institution - 0214
ABB, Buenos Aires F.D., Argentina, C1199ABB
Withdrawn
25
Hospital Aleman
Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
Actively Recruiting
26
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
27
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
28
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Actively Recruiting
29
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
30
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
31
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
32
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
33
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
34
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria, 4020
Actively Recruiting
35
Hanusch-Krankenhaus
Vienna, Austria, 1140
Actively Recruiting
36
Antwerp University Hospital
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
37
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
Actively Recruiting
38
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, Namur, Belgium, 5530
Actively Recruiting
39
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
40
Local Institution - 0012
Nova Lima, Minas Gerais, Brazil, 34000-000
Not Yet Recruiting
41
A. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01509-010
Actively Recruiting
42
Local Institution - 0103
São Paulo, São Paulo, Brazil, 04501-000
Not Yet Recruiting
43
Local Institution - 0031
São Paulo, Brazil, 05652-900
Not Yet Recruiting
44
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
45
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
46
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
47
Local Institution - 0192
Hamilton, Ontario, Canada, L8V5C2
Not Yet Recruiting
48
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
49
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia, 625 00
Actively Recruiting
50
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia, 500 05
Actively Recruiting
51
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Actively Recruiting
52
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 12808
Actively Recruiting
53
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
54
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
55
Roskilde Sygehus
Roskilde, Region Sjælland, Denmark, 4000
Actively Recruiting
56
Odense Universitetshospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
57
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
58
Oulun yliopistollinen sairaala
Oulu, Finland, 90220
Actively Recruiting
59
Turku University Hospital
Turku, Finland, 20251
Actively Recruiting
60
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France, 59000
Actively Recruiting
61
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
62
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France, 69310
Actively Recruiting
63
Henri Mondor Hospital
Créteil, Val-de-Marne, France, 94010
Actively Recruiting
64
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
65
TUM Klinikum
Munich, Bavaria, Germany, 81675
Actively Recruiting
66
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
67
Klinikum Chemnitz - Flemmingstraße
Chemnitz, Saxony, Germany, 09116
Actively Recruiting
68
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
69
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany, 39120
Actively Recruiting
70
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
71
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Actively Recruiting
72
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
73
Universitaetsklinikum Heidelberg
Heidelberg, Germany, D-69120
Actively Recruiting
74
Klinikum Nuernberg Nord
Nuremberg, Germany, 90419
Actively Recruiting
75
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97080
Actively Recruiting
76
University Hospital of Patras
Pátrai, Achaḯa, Greece, 26504
Actively Recruiting
77
Evangelismos General Hospital of Athens
Athens, Attikí, Greece, 106 76
Actively Recruiting
78
Attikon General University Hospital
Chaïdári, Attikí, Greece, 12462
Actively Recruiting
79
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
80
Local Institution - 0125
Budapest, Hungary, 1097
Not Yet Recruiting
81
Sheba Medical Center
Ramat Gan, Central District, Israel, 5262100
Actively Recruiting
82
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
83
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel, 6423906
Actively Recruiting
84
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy, 20133
Actively Recruiting
85
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
86
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
87
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
88
Ospedale San Martino
Genova, Italy, 16132
Actively Recruiting
89
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy, 33100
Actively Recruiting
90
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
91
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
92
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan, 663-8501
Actively Recruiting
93
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
94
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
95
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
96
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192
Actively Recruiting
97
Osaka Red Cross Hospital
Osaka, Japan, 543-8555
Actively Recruiting
98
Japanese Red Cross Medical Center
Tokyo, Japan, 150-8935
Actively Recruiting
99
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
100
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
101
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
102
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
103
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
104
Sykehusapoteket Ull
Oslo, Norway, 0450
Actively Recruiting
105
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lublin Voivodeship, Poland, 20-090
Actively Recruiting
106
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
107
Local Institution - 0084
Katowice, Poland, 40-519
Not Yet Recruiting
108
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland, 93-513
Actively Recruiting
109
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Actively Recruiting
110
Fundeni Clinical Institute
Bucharest, Bucharest, Romania, 022328
Actively Recruiting
111
Institutul Regional de Oncologie
Iași, Romania, 700483
Actively Recruiting
112
Local Institution - 0178
Riyadh, Saudi Arabia, 12713
Not Yet Recruiting
113
National University Hospital
Singapore, Central Singapore, Singapore, 119074
Actively Recruiting
114
Local Institution - 0181
Singapore, Central Singapore, Singapore, 169608
Not Yet Recruiting
115
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
Actively Recruiting
116
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
Actively Recruiting
117
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Actively Recruiting
118
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
Actively Recruiting
119
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
Actively Recruiting
120
Hospital Universitari Son Espases
Palma, Balears [Baleares], Spain, 07120
Actively Recruiting
121
Institut Catalan d Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], Spain, 08916
Actively Recruiting
122
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
123
Hospital Universitario Virgen Nieves
Granada, Spain, 18012
Actively Recruiting
124
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
125
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
Actively Recruiting
126
Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden, 141 86
Actively Recruiting
127
Skånes Universitetssjukhus Lund
Lund, Sweden, 222 42
Actively Recruiting
128
Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
129
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
130
National Taiwan University Cancer Center (NTUCC)
Taipei City, Taipei, Taiwan, 106
Actively Recruiting
131
China Medical University Hospital
Taichung, Taiwan, 404332
Actively Recruiting
132
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
133
Local Institution - 0200
Taipei, Taiwan, 11217
Not Yet Recruiting
134
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
135
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
136
University College London Hospital
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
137
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Actively Recruiting
138
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
139
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
140
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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