NCT06615479

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)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
DRUG	BMS-986393	Specified dose on specified days
DRUG	Cyclophosphamide	Specified dose on specified days
DRUG	Fludarabine	Specified dose on specified days
DRUG	Daratumumab	Specified dose on specified days
DRUG	Pomalidomide	Specified dose on specified days
DRUG	Dexamethasone	Specified dose on specified days
DRUG	Carfilzomib	Specified dose on specified days

Timeline

• Start date: 2025-03-12
• Primary completion: 2027-12-30
• Completion: 2032-06-22
• First posted: 2024-09-26
• Last updated: 2026-04-14

Locations

138 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study