A Phase 3 Study of a GPRC5D-directed CAR T Cell Therapy in Participants with Relapsed or Refractory Multiple Myeloma and Exposed to Lenalidomide.

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 Participantswith Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma(QUINTESSENTIAL-2)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2053250007

Enrollment

440

Registered

2025-04-28

Start date

2025-05-20

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

- Arm A: BMS-986393 (single intravenous infusion) - Arm B: standard of care until disease progression - DPd = daratumumab + pomalidomide + dexamethasone - Kd = carfilzomib + dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must have relapsed or refractory multiple myeloma (RRMM). Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria. 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 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

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.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) Minimal residual disease (MRD)-negativity in complete response (CR)	—

Secondary

Measure	Time frame
Overall survival (OS) Overall response rate (ORR)	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactLamis Eldjerou

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026