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)
NCT ID: NCT06615479
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2025-03-12
2032-06-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
BMS-986393
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Fludarabine
Specified dose on specified days
Daratumumab
Specified dose on specified days
Pomalidomide
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Arm B
Daratumumab
Specified dose on specified days
Pomalidomide
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Interventions
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BMS-986393
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Fludarabine
Specified dose on specified days
Daratumumab
Specified dose on specified days
Pomalidomide
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
* Participants must not need urgent treatment due to rapidly progressing MM.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
Local Institution - 0130
Miami, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Local Institution - 0218
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Local Institution - 0219
Minneapolis, Minnesota, United States
Local Institution - 0067
Charlotte, North Carolina, United States
Local Institution - 0216
Winston-Salem, North Carolina, United States
Local Institution - 0193
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Local Institution - 0184
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Local Institution - 0195
Milwaukee, Wisconsin, United States
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Local Institution - 0214
ABB, Buenos Aires F.D., Argentina
Hospital Aleman
Buenos Aires, Buenos Aires F.D., Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Local Institution - 0190
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital of North Terrace
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peter MacCallum
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Hanusch-Krankenhaus
Vienna, , Austria
Local Institution - 0220
Edegem, Antwerpen, Belgium
Local Institution - 0217
Brussels, Bruxelles-Capitale, Région de, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, Namur, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0012
Nova Lima, Minas Gerais, Brazil
Local Institution - 0013
São Paulo, São Paulo, Brazil
Local Institution - 0103
São Paulo, São Paulo, Brazil
Local Institution - 0031
São Paulo, , Brazil
Local Institution - 0069
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada
Local Institution - 0192
Hamilton, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Local Institution - 0093
Hradec Králové, Hradec Králové, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Rigshospitalet
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark
Roskilde Sygehus
Roskilde, Region Sjælland, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, Finland
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
Local Institution - 0194
Nantes, Pays de la Loire Region, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Henri Mondor Hospital
Créteil, Val-de-Marne, France
Local Institution - 0210
Paris, , France
TUM Klinikum
Munich, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Local Institution - 0204
Chemnitz, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Local Institution - 0211
Magdeburg, Saxony-Anhalt, Germany
Local Institution - 0212
Kiel, Schleswig-Holstein, Germany
Local Institution - 0213
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Klinikum Nuernberg Nord
Nuremberg, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
University Hospital of Patras
Pátrai, Achaḯa, Greece
Evangelismos General Hospital of Athens
Athens, Attikí, Greece
Attikon General University Hospital
Chaïdári, Attikí, Greece
Local Institution - 0125
Budapest, , Hungary
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, , Italy
Local Institution - 0119
Genova, , Italy
Local Institution - 0106
Udine, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kyushu University Hospital
Fukuoka, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Red Cross Hospital
Osaka, , Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
Yamagata University Hospital
Yamagata, , Japan
Radboudumc
Nijmegen, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Local Institution - 0179
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Sykehusapoteket Ull
Oslo, , Norway
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lublin Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0084
Katowice, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Fundeni Clinical Institute
Bucharest, București, Romania
Institutul Regional de Oncologie
Iași, , Romania
Local Institution - 0178
Riyadh, , Saudi Arabia
Local Institution - 0180
Singapore, Central Singapore, Singapore
Local Institution - 0181
Singapore, Central Singapore, Singapore
Local Institution - 0147
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0146
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0148
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0149
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], Spain
Local Institution - 0203
Palma, Balears [Baleares], Spain
Local Institution - 0201
Badalona, Barcelona [Barcelona], Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Local Institution - 0202
Granada, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Local Institution - 0023
Lund, Skåne Län [se-12], Sweden
Karolinska Universitetssjukhuset Huddinge
Huddinge, , Sweden
Inselspital Bern
Bern, Canton of Bern, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Local Institution - 0150
Taipei City, Taipei, Taiwan
Local Institution - 0151
Taichung, , Taiwan
Local Institution - 0152
Taipei, , Taiwan
Local Institution - 0200
Taipei, , Taiwan
Local Institution - 0170
Ankara, , Turkey (Türkiye)
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
University College London Hospital
London, London, City of, United Kingdom
Local Institution - 0157
Oxford, Oxfordshire, United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Susan Bal, Site 0071
Role: primary
Sarah Larson, Site 0032
Role: primary
Site 0130
Role: primary
Nisha Joseph, Site 0058
Role: primary
Site 0218
Role: primary
Raphael Szalat, Site 0196
Role: primary
Site 0219
Role: primary
Site 0067
Role: primary
Site 0216
Role: primary
Site 0193
Role: primary
Asya Varshavsky-Yanovsky, Site 0097
Role: primary
Site 0184
Role: primary
Brian McClune, Site 0044
Role: primary
Site 0195
Role: primary
Natalia Schutz, Site 0122
Role: primary
Gonzalo Garate, Site 0121
Role: primary
Joy Ho, Site 0142
Role: primary
Site 0190
Role: primary
Fiona Swain, Site 0140
Role: primary
Cindy Lee, Site 0139
Role: primary
Danielle Oh, Site 0143
Role: primary
Amit Khot, Site 0138
Role: primary
Shafqat Inam, Site 0191
Role: primary
Stephanie Lam, Site 0141
Role: primary
Irene Strassl, Site 0167
Role: primary
Felix Keil, Site 0166
Role: primary
Site 0220
Role: primary
Site 0217
Role: primary
Gilles CROCHET, Site 0162
Role: primary
Nicolas Kint, Site 0175
Role: primary
Site 0012
Role: primary
Site 0013
Role: primary
Site 0103
Role: primary
Site 0031
Role: primary
Site 0069
Role: primary
Hannah Cherniawsky, Site 0003
Role: primary
Darrell White, Site 0004
Role: primary
Site 0192
Role: primary
Richard LeBlanc, Site 0001
Role: primary
Ludek Pour, Site 0094
Role: primary
Site 0093
Role: primary
Jan Straub, Site 0129
Role: primary
Anne Mylin, Site 0019
Role: primary
Maja Vase, Site 0020
Role: primary
Nicolai Jørgensen, Site 0208
Role: primary
Ida Kristensen, Site 0022
Role: primary
Mikko Keranen, Site 0026
Role: primary
Salomon Manier, Site 0081
Role: primary
Site 0194
Role: primary
Lionel Karlin, Site 0080
Role: primary
Karim BELHADJ-MERZOUG, Site 0079
Role: primary
Site 0210
Role: primary
Judith Hecker, Site 0185
Role: primary
Annamaria Brioli, Site 0186
Role: primary
Site 0204
Role: primary
Vladan Vucinic, Site 0164
Role: primary
Site 0211
Role: primary
Site 0212
Role: primary
Site 0213
Role: primary
Katja Weisel, Site 0188
Role: primary
Marc-Steffen Raab, Site 0165
Role: primary
Stefan Knop, Site 0187
Role: primary
Martin Kortuem, Site 0169
Role: primary
Alexandros Spyridonidis, Site 0111
Role: primary
Ioannis Baltadakis, Site 0117
Role: primary
Evangelos Terpos, Site 0115
Role: primary
Site 0125
Role: primary
Hila Magen, Site 0112
Role: primary
Eyal Lebel, Site 0116
Role: primary
Ron Ram, Site 0118
Role: primary
Paolo Corradini, Site 0107
Role: primary
Stefania Bramanti, Site 0109
Role: primary
Francesca Gay, Site 0128
Role: primary
Elena Zamagni, Site 0108
Role: primary
Site 0119
Role: primary
Site 0106
Role: primary
Masaki Ri, Site 0098
Role: primary
Junichiro Yuda, Site 0105
Role: primary
Satoshi Yoshihara, Site 0087
Role: primary
Hiroyuki Takamatsu, Site 0104
Role: primary
Kohta Miyawaki, Site 0089
Role: primary
Yawara Kawano, Site 0102
Role: primary
YASUHISA Sando, Site 0090
Role: primary
Kazunori Imada, Site 0099
Role: primary
Tadao Ishida, Site 0091
Role: primary
Satoshi Ito, Site 0100
Role: primary
Elizabeth De Kort, Site 0176
Role: primary
Janine Van Elssen, Site 0163
Role: primary
Site 0179
Role: primary
Rimke Oostvogels, Site 0171
Role: primary
Ingerid Abrahamsen, Site 0016
Role: primary
Wojciech Legiec, Site 0092
Role: primary
Jan Zaucha, Site 0083
Role: primary
Site 0084
Role: primary
Agnieszka Wierzbowska, Site 0183
Role: primary
Jose Mariz, Site 0137
Role: primary
Alina Tanase, Site 0173
Role: primary
Angela Dascalescu, Site 0172
Role: primary
Site 0178
Role: primary
Site 0180
Role: primary
Site 0181
Role: primary
Site 0147
Role: primary
Site 0146
Role: primary
Site 0148
Role: primary
Site 0149
Role: primary
Marta Sonia GOnzalez Perez, Site 0136
Role: primary
Site 0203
Role: primary
Site 0201
Role: primary
Paula Rodriguez Otero, Site 0135
Role: primary
Site 0202
Role: primary
Maria Victoria Mateos Manteca, Site 0134
Role: primary
Site 0023
Role: primary
Johan Törlén, Site 0027
Role: primary
Thomas Pabst, Site 0205
Role: primary
ILIAS STAGAKIS, Site 0168
Role: primary
Site 0150
Role: primary
Site 0151
Role: primary
Site 0152
Role: primary
Site 0200
Role: primary
Site 0170
Role: primary
Faisal Basheer, Site 0182
Role: primary
Rakesh Popat, Site 0155
Role: primary
Site 0157
Role: primary
Ahmed Abdulgawad, Site 0174
Role: primary
Thomas Creasey, Site 0154
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA088-1007
Identifier Type: -
Identifier Source: org_study_id