A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)
- Interventions
- Registration Number
- NCT06615479
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief Summary
The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 440
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A BMS-986393 - Arm A Cyclophosphamide - Arm A Dexamethasone - Arm B Carfilzomib - Arm A Fludarabine - Arm A Daratumumab - Arm A Pomalidomide - Arm B Daratumumab - Arm A Carfilzomib - Arm B Pomalidomide - Arm B Dexamethasone -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to 5 years after the last participant is randomized Minimal residual disease (MRD)-negativity in complete response (CR) Up to 1 year after the last participant is randomized
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to 5 years after the last participant is randomized Overall response rate (ORR) Up to 5 years after the last participant is randomized Minimal residual disease (MRD)-negative status Up to 5 years after the last participant is randomized Complete response rate (CRR) Up to 5 years after the last participant is randomized Time to response (TTR) Up to 5 years after the last participant is randomized Duration of response (DOR) Up to 5 years after the last participant is randomized The proportion of participants with adverse events (AEs) Up to 5 years after the last participant is randomized The proportion of participants with adverse events of special interest (AESI) Up to 5 years after the last participant is randomized The proportion of participants with serious adverse events (SAEs) Up to 5 years after the last participant is randomized Maximum observed concentration (Cmax) of transgene level Up to 5 years after the last participant is randomized Time of maximum observed plasma concentration (Tmax) of transgene level Up to 5 years after the last participant is randomized Area under the concentration-time curve (AUC) of transgene level 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 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).
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains Up to 5 years after the last participant is randomized EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL. Up to 5 years after the last participant is randomized
Trial Locations
- Locations (121)
Local Institution - 0071
🇺🇸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 - 0196
🇺🇸Boston, Massachusetts, United States
Local Institution - 0193
🇺🇸Cleveland, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0044
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0195
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0122
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0214
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0121
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0142
🇦🇺Camperdown, New South Wales, Australia
Local Institution - 0190
🇦🇺Liverpool, New South Wales, Australia
Local Institution - 0140
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0139
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0143
🇦🇺Clayton, Victoria, Australia
Local Institution - 0138
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0191
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0141
🇦🇺Murdoch, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Oberösterreich, Austria
Hanusch-Krankenhaus
🇦🇹Vienna, Austria
Local Institution - 0162
🇧🇪Yvoir, Namur, Belgium
Local Institution - 0175
🇧🇪Gent, Oost-Vlaanderen, Belgium
Local Institution - 0012
🇧🇷Nova Lima, Minas Gerais, Brazil
Local Institution - 0103
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 0013
🇧🇷Sao Paulo, São Paulo, Brazil
Local Institution - 0031
🇧🇷São Paulo, Brazil
Local Institution - 0069
🇨🇦Calgary, Alberta, Canada
Local Institution - 0003
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0004
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0192
🇨🇦Hamilton, Ontario, Canada
Local Institution - 0001
🇨🇦Montreal, Quebec, Canada
Local Institution - 0094
🇨🇿Brno, Brno-město, Czechia
Local Institution - 0093
🇨🇿Hradec Kralove, Hradec Králové, Czechia
Local Institution - 0129
🇨🇿Praha 2, Czechia
Local Institution - 0019
🇩🇰Copenhagen, Hovedstaden, Denmark
Local Institution - 0186
🇩🇪Hannover, Germany
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Local Institution - 0208
🇩🇰Roskilde, Sjælland, Denmark
Local Institution - 0022
🇩🇰Odense, 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, France
Local Institution - 0080
🇫🇷Pierre-Bénite, Rhône, France
Local Institution - 0079
🇫🇷Creteil, Val-de-Marne, France
Local Institution - 0210
🇫🇷Paris, France
TUM Universitätsklinikum, Technische Universität München
🇩🇪Munich, Bayern, Germany
Local Institution - 0187
🇩🇪Nürnberg, Bayern, Germany
Local Institution - 0211
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Local Institution - 0204
🇩🇪Chemnitz, Sachsen, Germany
Local Institution - 0164
🇩🇪Leipzig, Sachsen, Germany
Local Institution - 0212
🇩🇪Kiel, Schleswig-Holstein, Germany
Local Institution - 0213
🇩🇪Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Local Institution - 0169
🇩🇪Wuerzburg, Germany
Local Institution - 0111
🇬🇷Patras, Achaḯa, Greece
Local Institution - 0117
🇬🇷Athens, Attikí, Greece
Local Institution - 0115
🇬🇷Chaidari, Attikí, Greece
Local Institution - 0125
🇭🇺Budapest, Hungary
Local Institution - 0124
🇭🇺Debrecen, Hungary
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Local Institution - 0107
🇮🇹Milan, Lombardia, Italy
Local Institution - 0109
🇮🇹Rozzano, Milano, Italy
Local Institution - 0128
🇮🇹Torino, Piemonte, Italy
Local Institution - 0108
🇮🇹Bologna, Italy
Local Institution - 0119
🇮🇹Genova, Italy
Local Institution - 0106
🇮🇹Udine, Italy
Local Institution - 0098
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0105
🇯🇵Kashiwa, Chiba, Japan
Local Institution - 0087
🇯🇵Nishinomiya, Hyogo, Japan
Local Institution - 0104
🇯🇵Kanazawa, Ishikawa, Japan
Local Institution - 0089
🇯🇵Fukuoka, Japan
Local Institution - 0102
🇯🇵Kumamoto, Japan
Local Institution - 0090
🇯🇵Okayama, Japan
Local Institution - 0099
🇯🇵Osaka, Japan
Local Institution - 0091
🇯🇵Tokyo, Japan
Local Institution - 0100
🇯🇵Yamagata, Japan
Local Institution - 0147
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0146
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0148
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0149
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0176
🇳🇱Nijmegen, Gelderland, Netherlands
Local Institution - 0163
🇳🇱Maastricht, Limburg, Netherlands
Local Institution - 0179
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0161
🇳🇱Groningen, Netherlands
Local Institution - 0159
🇳🇱Utrecht, Netherlands
Local Institution - 0171
🇳🇱Utrecht, Netherlands
Oslo Universitetssykehus Ullevål
🇳🇴Oslo, Norway
Centrum Onkologii Ziemi Lubelskiej
🇵🇱Lublin, Lubelskie, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Pomorskie, Poland
Local Institution - 0084
🇵🇱Katowice, Poland
Local Institution - 0183
🇵🇱Łódź, Łódzkie, Poland
Local Institution - 0137
🇵🇹Porto, Portugal
Fundeni Clinical Institute
🇷🇴Bucuresti, 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 - 0136
🇪🇸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, Navarra, Spain
Local Institution - 0202
🇪🇸Granada, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
Local Institution - 0027
🇸🇪Huddinge, Sweden
Local Institution - 0205
🇨🇭Bern, Berne, Switzerland
Cantonal Hospital St.Gallen
🇨🇭st.Gallen, Sankt 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
Local Institution - 0182
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Local Institution - 0155
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0157
🇬🇧Oxford, Oxfordshire, United Kingdom
Local Institution - 0174
🇬🇧Manchester, United Kingdom
Local Institution - 0154
🇬🇧Newcastle upon Tyne, United Kingdom