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NCT06615479Recruiting

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)

Summary

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.

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

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, Greece, Hungary, Israel, Japan, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company(Industry)
Protocol no.
CA088-1007
Conditions
Relapsed or Refractory Multiple Myeloma (RRMM)
Interventions
Drug

Treatments studied

  • BMS-986393
  • Cyclophosphamide
  • Fludarabine
  • Daratumumab
  • Pomalidomide
  • Dexamethasone
  • Carfilzomib

Collaborators

Celgene Corporation

Locations · 130

  • Bern, SwitzerlandInselspital BernRecruiting at this site
  • Sankt Gallen, SwitzerlandCantonal Hospital St.GallenRecruiting at this site
  • Lille, FranceHopital Claude Huriez - CHU de LilleRecruiting at this site
  • Nantes, FranceCentre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting at this site
  • Pierre-Bénite, FranceCentre Hospitalier Lyon SudRecruiting at this site
  • Créteil, FranceHenri Mondor HospitalRecruiting at this site
  • Paris, FranceHôpital Saint-LouisRecruiting at this site
  • Munich, GermanyTUM KlinikumRecruiting at this site
  • Hanover, GermanyMedizinische Hochschule HannoverRecruiting at this site
  • Chemnitz, GermanyKlinikum Chemnitz - FlemmingstraßeRecruiting at this site
  • Leipzig, GermanyUniversitätsklinikum LeipzigRecruiting at this site
  • Magdeburg, GermanyUniversitaetsklinikum MagdeburgRecruiting at this site
  • Kiel, GermanyUniversitaetsklinikum Schleswig-Holstein Campus KielRecruiting at this site
  • Berlin, GermanyCharité Campus Virchow-KlinikumRecruiting at this site
  • Hamburg, GermanyUniversitaetsklinikum Hamburg-EppendorfRecruiting at this site
  • Heidelberg, GermanyUniversitaetsklinikum HeidelbergRecruiting at this site
  • Nuremberg, GermanyKlinikum Nuernberg NordRecruiting at this site
  • Würzburg, GermanyUniversitaetsklinikum WuerzburgRecruiting at this site
  • Milan, ItalyFondazione IRCCS Istituto Nazionale dei TumoriRecruiting at this site
  • Rozzano, ItalyIstituto Clinico HumanitasRecruiting at this site
  • Turin, ItalyAzienda Ospedaliero-Universitaria Città della Salute e della Scienza di TorinoRecruiting at this site
  • Bologna, ItalyIRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaRecruiting at this site
  • Genova, ItalyIRCCS AOM Azienda Ospedaliera MetropolitanaRecruiting at this site
  • Udine, ItalyP.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli CentraleRecruiting at this site
  • Linz, AustriaOrdensklinikum Linz GmbH ElisabethinenRecruiting at this site
  • Vienna, AustriaHanusch-KrankenhausRecruiting at this site
  • Birmingham, United StatesUniversity of Alabama at BirminghamRecruiting at this site
  • Los Angeles, United StatesUCLA Hematology/Oncology - Santa MonicaRecruiting at this site
  • Orange, United StatesUniversity of California, Irvine (UCI) Health - UC Irvine Medical CenterRecruiting at this site
  • Washington D.C., United StatesGeorgetown University Medical CenterRecruiting at this site

In total, worldwide, 130 of the 141 sites listed in the registry are recruiting; the other 11 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 15, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 100 more locations

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.