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)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Information Provided by (Responsible Party)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Clinicaltrials.gov Identifier
NCT06615479
Other Study ID Numbers:
CA088-1007
First Submitted
September 23, 2024
First Posted
September 25, 2024
Last Update Posted
May 12, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Relapsed or Refractory Multiple Myeloma (RRMM)
Drug: BMS-986393Drug: Daratumumab

Study Design

Study TypeInterventional
Actual Enrollment440 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 11, 2025
Actual Primary Completion Date1yr 7mos from now
Actual Study Completion Date6yrs 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A
Drug: BMS-986393
Specified dose on specified days
Arm B
Drug: Daratumumab
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Progression Free Survival (PFS)
  2. Minimal residual disease (MRD)-negativity in complete response (CR)
Secondary Outcome Measures
  1. Overall survival (OS)
  2. Overall response rate (ORR)
  3. Minimal residual disease (MRD)-negative status
  4. Complete response rate (CRR)
  5. Time to response (TTR)
  6. Duration of response (DOR)
  7. Maximum observed concentration (Cmax) of transgene level
  8. Time of maximum observed plasma concentration (Tmax) of transgene level
  9. Area under the concentration-time curve (AUC) of transgene level
  10. 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).
  11. 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
  12. Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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 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
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 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 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.

Contacts and Locations

Sponsors and CollaboratorsJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35205UCLA Hematology/Oncology - Santa Monica | Los Angeles California, United States, 90404University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange California, United States, 92868Local Institution - 0223 | Washington D.C. District of Columbia, United States, 20007Baptist MD Anderson Cancer Center | Jacksonville Florida, United States, 32207University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami Florida, United States, 33136Local Institution - 0228 | Orlando Florida, United States, 32803Winship Cancer Institute, Emory University | Atlanta Georgia, United States, 30322Louisiana State University Health Sciences Shreveport | Shreveport Louisiana, United States, 71103Boston Medical Center | Boston Massachusetts, United States, 02118Local Institution - 0219 | Minneapolis Minnesota, United States, 55455Weill Cornell Medical College | New York New York, United States, 10065Local Institution - 0221 | Stony Brook New York, United States, 11794Levine Cancer Institute | Charlotte North Carolina, United States, 28204Levine Cancer Institute | Charlotte North Carolina, United States, 28204Cleveland Clinic | Cleveland Ohio, United States, 44195Fox Chase Cancer Center | Philadelphia Pennsylvania, United States, 19111Local Institution - 0232 | Pittsburgh Pennsylvania, United States, 15224Local Institution - 0227 | Charleston South Carolina, United States, 29425Local Institution - 0184 | Houston Texas, United States, 77030Huntsman Cancer Institute | Salt Lake City Utah, United States, 84112Medical College of Wisconsin | Milwaukee Wisconsin, United States, 53226Hospital Italiano de Buenos Aires | ABB Buenos Aires F.D., Argentina, C1199ABBLocal Institution - 0214 | ABB Buenos Aires F.D., Argentina, C1199ABBHospital Aleman | Buenos Aires Buenos Aires F.D., Argentina, C1118AATRoyal Prince Alfred Hospital | Camperdown New South Wales, Australia, 2050Liverpool Hospital | Liverpool New South Wales, Australia, 2170Princess Alexandra Hospital | Brisbane Queensland, Australia, 4102Royal Adelaide Hospital | Adelaide South Australia, Australia, 5000Monash Health | Clayton Victoria, Australia, 3168Peter MacCallum Cancer Centre | Melbourne Victoria, Australia, 3000The Alfred Hospital | Melbourne Victoria, Australia, 3004Fiona Stanley Hospital | Murdoch Western Australia, Australia, 6150Ordensklinikum Linz GmbH Elisabethinen | Linz Upper Austria, Austria, 4020Hanusch-Krankenhaus | Vienna , Austria, 1140Antwerp University Hospital | Edegem Antwerpen, Belgium, 2650Local Institution - 0217 | Brussels Bruxelles-Capitale, Région de, Belgium, 1200Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Yvoir Namur, Belgium, 5530UZ Gent | Ghent Oost-Vlaanderen, Belgium, 9000Local Institution - 0012 | Nova Lima Minas Gerais, Brazil, 34000-000A. C. Camargo Cancer Center | São Paulo São Paulo, Brazil, 01509-010Local Institution - 0103 | São Paulo São Paulo, Brazil, 04501-000Local Institution - 0031 | São Paulo , Brazil, 05652-900Arthur J.E. Child Comprehensive Cancer Centre | Calgary Alberta, Canada, T2N 5G2Vancouver General Hospital | Vancouver British Columbia, Canada, V5Z 1M9QEII Health Sciences Centre - Victoria General Site | Halifax Nova Scotia, Canada, B3H 2Y9Local Institution - 0192 | Hamilton Ontario, Canada, L8V5C2CIUSSS de l'Est-de-l'Île-de-Montréal | Montreal Quebec, Canada, H1T 2M4Fakultní nemocnice Brno Bohunice | Brno Brno-město, Czechia, 625 00Local Institution - 0093 | Hradec Králové Hradec Králové, Czechia, 500 05Vseobecna fakultni nemocnice v Praze | Prague , Czechia, 12808Rigshospitalet | Copenhagen Capital Region, Denmark, 2100Aarhus Universitetshospital, Skejby | Aarhus Central Jutland, Denmark, 8200Roskilde Sygehus | Roskilde Region Sjælland, Denmark, 4000Odense Universitetshospital | Odense Region Syddanmark, Denmark, 5000Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) | Helsinki Uusimaa, Finland, 00029Oulun yliopistollinen sairaala | Oulu , Finland, 90220Turku University Hospital | Turku , Finland, 20251Hopital Claude Huriez - CHU de Lille | Lille Nord, France, 59000Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Nantes Pays de la Loire Region, France, 44000Centre Hospitalier Lyon Sud | Pierre-Bénite Rhône, France, 69310Henri Mondor Hospital | Créteil Val-de-Marne, France, 94010Hôpital Saint-Louis | Paris , France, 75010TUM Klinikum | Munich Bavaria, Germany, 81675Medizinische Hochschule Hannover | Hanover Lower Saxony, Germany, 30625Klinikum Chemnitz - Flemmingstraße | Chemnitz Saxony, Germany, 09116Universitätsklinikum Leipzig | Leipzig Saxony, Germany, 04103Universitaetsklinikum Magdeburg | Magdeburg Saxony-Anhalt, Germany, 39120Universitaetsklinikum Schleswig-Holstein Campus Kiel | Kiel Schleswig-Holstein, Germany, 24105Charité Campus Virchow-Klinikum | Berlin , Germany, 13353Universitaetsklinikum Hamburg-Eppendorf | Hamburg , Germany, 20246Universitaetsklinikum Heidelberg | Heidelberg , Germany, D-69120Klinikum Nuernberg Nord | Nuremberg , Germany, 90419Universitaetsklinikum Wuerzburg | Würzburg , Germany, 97080University Hospital of Patras | Pátrai Achaḯa, Greece, 26504Evangelismos General Hospital of Athens | Athens Attikí, Greece, 106 76Attikon General University Hospital | Chaïdári Attikí, Greece, 12462Debreceni Egyetem Klinikai Kozpont | Debrecen Hajdú-Bihar, Hungary, 4032Local Institution - 0125 | Budapest , Hungary, 1097Sheba Medical Center | Ramat Gan Central District, Israel, 5262100Hadassah Medical Center | Jerusalem Jerusalem, Israel, 9112001Sourasky Medical Center | Tel Aviv Tell Abīb, Israel, 6423906Fondazione IRCCS Istituto Nazionale dei Tumori | Milan Lombardy, Italy, 20133Istituto Clinico Humanitas | Rozzano Milano, Italy, 20089Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino | Turin Piedmont, Italy, 10126IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna , Italy, 40138Ospedale San Martino | Genova , Italy, 16132P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale | Udine , Italy, 33100Nagoya City University Hospital | Nagoya Aichi-ken, Japan, 467-8602National Cancer Center Hospital East | Kashiwa Chiba, Japan, 277-8577Hyogo Medical University Hospital | Nishinomiya Hyōgo, Japan, 663-8501Kanazawa University Hospital | Kanazawa Ishikawa-ken, Japan, 920-8641Kyushu University Hospital | Fukuoka , Japan, 812-8582Kumamoto University Hospital | Kumamoto , Japan, 860-8556National Hospital Organization Okayama Medical Center | Okayama , Japan, 701-1192Osaka Red Cross Hospital | Osaka , Japan, 543-8555Japanese Red Cross Medical Center | Tokyo , Japan, 150-8935Yamagata University Hospital | Yamagata , Japan, 990-9585Radboudumc | Nijmegen Gelderland, Netherlands, 6525 GAMaastricht UMC+ | Maastricht Limburg, Netherlands, 6229 HXAmsterdam UMC, locatie VUmc | Amsterdam North Holland, Netherlands, 1081 HVUniversitair Medisch Centrum Utrecht | Utrecht , Netherlands, 3584 CXSykehusapoteket Ull | Oslo , Norway, 0450Centrum Onkologii Ziemi Lubelskiej | Lublin Lublin Voivodeship, Poland, 20-090Uniwersyteckie Centrum Kliniczne | Gdansk Pomeranian Voivodeship, Poland, 80-214Local Institution - 0084 | Katowice , Poland, 40-519Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz Łódź Voivodeship, Poland, 93-513Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Porto , Portugal, 4200-072Fundeni Clinical Institute | Bucharest Bucharest, Romania, 022328Institutul Regional de Oncologie | Iași , Romania, 700483Local Institution - 0178 | Riyadh , Saudi Arabia, 12713National University Hospital | Singapore Central Singapore, Singapore, 119074Local Institution - 0181 | Singapore Central Singapore, Singapore, 169608Seoul National University Hospital | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 03080Asan Medical Center | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 05505Samsung Medical Center | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 06351The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 06591CHUS - Hospital Clinico Universitario | Santiago de Compostela A Coruña [La Coruña], Spain, 15706Hospital Universitari Son Espases | Palma Balears [Baleares], Spain, 07120Institut Catalan d Oncologia (ICO) - Badalona | Badalona Barcelona [Barcelona], Spain, 08916Clinica Universidad de Navarra | Pamplona Navarre, Spain, 31008Hospital Universitario Virgen Nieves | Granada , Spain, 18012Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Salamanca , Spain, 37007Sahlgrenska Universitetssjukhuset | Gothenburg Västra Götalands Län [se-14], Sweden, 413 45Karolinska Universitetssjukhuset Huddinge | Huddinge , Sweden, 141 86Skånes Universitetssjukhus Lund | Lund , Sweden, 222 42Inselspital Bern | Bern Canton of Bern, Switzerland, 3010Cantonal Hospital St.Gallen | Sankt Gallen Canton of St. Gallen, Switzerland, 9007National Taiwan University Cancer Center (NTUCC) | Taipei City Taipei, Taiwan, 106China Medical University Hospital | Taichung , Taiwan, 404332National Taiwan University Hospital | Taipei , Taiwan, 10002Local Institution - 0200 | Taipei , Taiwan, 11217Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi | Ankara , Turkey (Türkiye), 06200Addenbrooke's Hospital | Cambridge Cambridgeshire, United Kingdom, CB2 2QQUniversity College London Hospital | London London, City of, United Kingdom, NW1 2PGChurchill Hospital | Oxford Oxfordshire, United Kingdom, OX3 7LEThe Christie NHS Foundation Trust | Manchester , United Kingdom, M20 4BXFreeman Hospital | Newcastle upon Tyne , United Kingdom, NE7 7DN
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb