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 (QUINTESSENTIAL-2)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515279-37-00

Acronym

CA088-1007

Enrollment

189

Registered

2025-03-31

Start date

2025-04-17

Completion date

Unknown

Last updated

2025-11-11

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

Conditions

Relapsed or Refractory and Lenalidomide exposed Multiple Myeloma

Brief summary

Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study., Minimal residual disease (MRD)-negative, complete response (CR): No signs of MM can be found in the participant’s body.

Detailed description

Overall survival (OS): The average time participants are alive after starting the study., Overall response rate (ORR): How many participants show a positive response to treatment.

Interventions

DRUGDEXAMETHASONE

DRUGFLUDARABINE PHOSPHATE

DRUGCARFILZOMIB

DRUGGPRC5D-TARGETED CAR T

DRUGDARATUMUMAB

DRUGPOMALIDOMIDE

DRUGDEXAMETHASONE SODIUM PHOSPHATE

DRUGTOCILIZUMAB

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study., Minimal residual disease (MRD)-negative, complete response (CR): No signs of MM can be found in the participant’s body.	—

Secondary

Measure	Time frame
Overall survival (OS): The average time participants are alive after starting the study., Overall response rate (ORR): How many participants show a positive response to treatment.	—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026