Clinical trial NCT06615479: 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)
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)
Keywords: Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
BMS-986393
Chimeric Antigen Receptor T-cell (CAR T-cell)
CAR T-cell Therapy
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
First posted: 2024-09-26
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

* 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 be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy).
* 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 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 5 years after the last participant is randomized
measure: Minimal residual disease (MRD)-negativity in complete response (CR)
timeFrame: Up to 1 year after the last participant is randomized
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years after the last participant is randomized
measure: Overall response rate (ORR)
timeFrame: Up to 5 years after the last participant is randomized
measure: Minimal residual disease (MRD)-negative status
timeFrame: Up to 5 years after the last participant is randomized
measure: Complete response rate (CRR)
timeFrame: Up to 5 years after the last participant is randomized
measure: Time to response (TTR)
timeFrame: Up to 5 years after the last participant is randomized
measure: Duration of response (DOR)
timeFrame: Up to 5 years after the last participant is randomized
measure: The proportion of participants with adverse events (AEs)
timeFrame: Up to 5 years after the last participant is randomized
measure: The proportion of participants with adverse events of special interest (AESI)
timeFrame: Up to 5 years after the last participant is randomized
measure: The proportion of participants with serious adverse events (SAEs)
timeFrame: Up to 5 years after the last participant is randomized
measure: Maximum observed concentration (Cmax) of transgene level
timeFrame: Up to 5 years after the last participant is randomized
measure: Time of maximum observed plasma concentration (Tmax) of transgene level
timeFrame: Up to 5 years after the last participant is randomized
measure: Area under the concentration-time curve (AUC) of transgene level
timeFrame: Up to 5 years after the last participant is randomized
measure: Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains
timeFrame: Up to 5 years after the last participant is randomized
measure: Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
timeFrame: Up to 5 years after the last participant is randomized
measure: Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
timeFrame: Up to 5 years after the last participant is randomized
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0071
state: Alabama
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Miami
country: United States
facility: Local Institution - 0130
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Boston
country: United States
facility: Local Institution - 0196
state: Massachusetts
city: Charlotte
country: United States
facility: Local Institution - 0067
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0216
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0193
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Local Institution - 0044
state: Utah
city: Milwaukee
country: United States
facility: Local Institution - 0195
state: Wisconsin
city: ABB
country: Argentina
facility: Local Institution - 0122
state: Ciudad Autónoma De Buenos Aires
city: ABB
country: Argentina
facility: Local Institution - 0214
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0121
state: Ciudad Autónoma De Buenos Aires
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Local Institution - 0190
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0140
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0139
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 0143
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0191
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0141
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Oberösterreich
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
city: Brussels
country: Belgium
facility: Local Institution - 0217
state: Bruxelles-Capitale, Région De
city: Yvoir
country: Belgium
facility: Local Institution - 0162
state: Namur
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Nova Lima
country: Brazil
facility: Local Institution - 0012
state: Minas Gerais
city: São Paulo
country: Brazil
facility: Local Institution - 0103
state: SAO Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0013
state: São Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 0031
city: Calgary
country: Canada
facility: Local Institution - 0069
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Local Institution - 0004
state: Nova Scotia
city: Hamilton
country: Canada
facility: Local Institution - 0192
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0001
state: Quebec
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0093
state: Hradec Králové
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Copenhagen
country: Denmark
facility: Local Institution - 0019
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Roskilde
country: Denmark
facility: Local Institution - 0208
state: Sjælland
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Syddanmark
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
state: Uusimaa
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Nantes
country: France
facility: Local Institution - 0194
state: Pays-de-la-Loire
city: Pierre-Bénite
country: France
facility: Local Institution - 0080
state: Rhône
city: Creteil
country: France
facility: Local Institution - 0079
state: Val-de-Marne
city: Paris
country: France
facility: Local Institution - 0210
city: Munich
country: Germany
facility: TUM Universitätsklinikum, Technische Universität München
state: Bayern
city: Magdeburg
country: Germany
facility: Local Institution - 0211
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Local Institution - 0204
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Kiel
country: Germany
facility: Local Institution - 0212
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Local Institution - 0213
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Local Institution - 0186
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Nuremberg
country: Germany
facility: Klinikum Nuernberg Nord
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaḯa
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attikí
city: Chaidari
country: Greece
facility: Local Institution - 0115
state: Attikí
city: Budapest
country: Hungary
facility: Local Institution - 0125
city: Debrecen
country: Hungary
facility: Local Institution - 0124
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Milan
country: Italy
facility: Local Institution - 0107
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Torino
country: Italy
facility: Local Institution - 0128
state: Piemonte
city: Bologna
country: Italy
facility: Local Institution - 0108
city: Genova
country: Italy
facility: Local Institution - 0119
city: Udine
country: Italy
facility: Local Institution - 0106
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: Local Institution - 0105
state: Chiba
city: Nishinomiya
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Local Institution - 0104
state: Ishikawa
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kumamoto
country: Japan
facility: Local Institution - 0102
city: Okayama
country: Japan
facility: Local Institution - 0090
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Tokyo
country: Japan
facility: Local Institution - 0091
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0147
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0146
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0148
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0149
state: Seoul-teukbyeolsi [Seoul]
city: Nijmegen
country: Netherlands
facility: Local Institution - 0176
state: Gelderland
city: Maastricht
country: Netherlands
facility: Local Institution - 0163
state: Limburg
city: Amsterdam
country: Netherlands
facility: Local Institution - 0179
state: Noord-Holland
city: Groningen
country: Netherlands
facility: Local Institution - 0161
city: Utrecht
country: Netherlands
facility: Local Institution - 0159
city: Utrecht
country: Netherlands
facility: Local Institution - 0171
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
state: Lubelskie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Katowice
country: Poland
facility: Local Institution - 0084
city: Łódź
country: Poland
facility: Local Institution - 0183
state: Łódzkie
city: Porto
country: Portugal
facility: Local Institution - 0137
city: Bucuresti
country: Romania
facility: Fundeni Clinical Institute
state: București
city: Iași
country: Romania
facility: Institutul Regional de Oncologie
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 0178
city: Singapore
country: Singapore
facility: Local Institution - 0180
state: Central Singapore
city: Singapore
country: Singapore
facility: Local Institution - 0181
state: Central Singapore
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0136
state: A Coruña [La Coruña]
city: Palma
country: Spain
facility: Local Institution - 0203
state: Balears [Baleares]
city: Badalona
country: Spain
facility: Local Institution - 0201
state: Barcelona [Barcelona]
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Granada
country: Spain
facility: Local Institution - 0202
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Lund
country: Sweden
facility: Local Institution - 0023
state: Skåne Län [se-12]
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Bern
country: Switzerland
facility: Local Institution - 0205
state: Berne
city: st.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
state: Sankt Gallen
city: Taipei City
country: Taiwan
facility: Local Institution - 0150
state: Taipei
city: Taichung
country: Taiwan
facility: Local Institution - 0151
city: Taipei
country: Taiwan
facility: Local Institution - 0152
city: Taipei
country: Taiwan
facility: Local Institution - 0200
city: Ankara
country: Turkey
facility: Local Institution - 0170
city: Cambridge
country: United Kingdom
facility: Local Institution - 0182
state: Cambridgeshire
city: London
country: United Kingdom
facility: Local Institution - 0155
state: London, City Of
city: Oxford
country: United Kingdom
facility: Local Institution - 0157
state: Oxfordshire
city: Manchester
country: United Kingdom
facility: Local Institution - 0174
city: Newcastle upon Tyne
country: United Kingdom
facility: Local Institution - 0154
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: