NCT06615479|RecruitingPhase 3DMCFDA Drug

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

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company ClinicalTrials.gov

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1 other identifier

CA088-1007

Study Type

interventional

Target

440

Locations

30 countries

Sites

136

Timeline

RegisteredSep 2024

StartedMar 2025

CompletionJun 2032

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

440

participants targeted

Target at P50-P75 for phase_3

Timeline

75mo left

Started Mar 2025

Longer than P75 for phase_3

Geographic Reach

30 countries

136 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.3 years study duration

Study Progress16%

Mar 2025Jun 2032

First Submitted

Initial submission to the registry

September 24, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed

6 months until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected

4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2032

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 24, 2024

Last Update Submit

April 13, 2026

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Keywords

Relapsed or Refractory Multiple MyelomaMultiple MyelomaBMS-986393Chimeric Antigen Receptor T-cell (CAR T-cell)CAR T-cell TherapyArlocabtagene AutoleucelArlo-cel

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS)
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Up to 1 year after the last participant is randomized

Secondary Outcomes (12)

Overall survival (OS)
Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Up to 5 years after the last participant is randomized
Complete response rate (CRR)
Up to 5 years after the last participant is randomized
Time to response (TTR)
Up to 5 years after the last participant is randomized
+7 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: BMS-986393Drug: CyclophosphamideDrug: FludarabineDrug: DaratumumabDrug: PomalidomideDrug: DexamethasoneDrug: Carfilzomib

Arm B

ACTIVE COMPARATOR

Drug: DaratumumabDrug: PomalidomideDrug: DexamethasoneDrug: Carfilzomib