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)

Juno Therapeutics

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)

Treatments: Drug: Daratumumab; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Fludarabine; Drug: BMS-986393; Drug: Carfilzomib; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615479

CA088-1007

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Cyclophosphamide

Drug: Carfilzomib

Drug: BMS-986393

Drug: Fludarabine

Drug: Pomalidomide

Drug: Dexamethasone

Drug: Daratumumab

Arm B

Active Comparator group

Treatment:

Drug: Carfilzomib

Drug: Pomalidomide

Drug: Dexamethasone

Drug: Daratumumab