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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

440 Participants
are divided into 2 treatment groups

Sponsors and collaborators