NCT06615479RecruitingPhase 3
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)
A 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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 24 Sept 2024
- Start date
- 12 Mar 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Diseases
- Multiple myeloma
- NCT number
- NCT06615479
- EU CT number
- 2024-515279-37-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 440
- From 12 Mar 2025 to the primary completion date, 30 Dec 2027
- 140 sites in 31 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Participants must not need urgent treatment due to rapidly progressing MM.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (140)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | ABB | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | ABB | Argentina | Withdrawn |
| Hospital Alemán Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| - Coordinator of this site? Confirm its status | Adelaide | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Brisbane | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Camperdown | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Clayton | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Liverpool | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Murdoch | Australia | Active, not recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Nova Lima | Brazil | Not yet recruiting |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| A.C. Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Instituto D'Or de Pesquisa e Ensino (IDOR) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| QEII Health Sciences Centre, Victoria General Site Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Hamilton Health Sciences-Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| CIUSSS de l'Est-de-l'Île-de-Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Cantonal Hospital St Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Otto Von Guericke Universitaet Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Nuernberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Recruiting |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Coordinator of this site? Confirm its status | Budapest IX | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Nishinomiya | Japan | Recruiting |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Osaka Red Cross Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Recruiting |
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Spitalul Universitar de Urgență București Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul Regional de Oncologie Iasi Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| - Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Withdrawn |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| - Coordinator of this site? Confirm its status | Singapore | Singapore | Withdrawn |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Cancer Center (NTUCC) Coordinator of this site? Confirm its status | Taipei City | Taiwan | Recruiting |
| Winship Cancer Institute, Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Charleston | United States | Withdrawn |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| UCLA Hematology/Oncology - Santa Monica Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Minneapolis | United States | Withdrawn |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Orlando | United States | Withdrawn |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Active, not recruiting |
| AHN West Penn Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Louisiana State University Health Sciences Shreveport Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Stony Brook | United States | Withdrawn |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.