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)

Phase 3

Recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)
• Interventions: Drug: BMS-986393; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Carfilzomib; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone

• Registration Number: NCT06615479
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Study Start: 2025-03-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-12-30
• Study Completion: 2032-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	BMS-986393	-
Arm A	Cyclophosphamide	-
Arm A	Dexamethasone	-
Arm B	Carfilzomib	-
Arm A	Fludarabine	-
Arm A	Daratumumab	-
Arm A	Pomalidomide	-
Arm B	Daratumumab	-
Arm A	Carfilzomib	-
Arm B	Pomalidomide	-
Arm B	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration of response (DOR)	Up to 5 years after the last participant is randomized
The proportion of participants with adverse events (AEs)	Up to 5 years after the last participant is randomized
The proportion of participants with adverse events of special interest (AESI)	Up to 5 years after the last participant is randomized
The proportion of participants with serious adverse events (SAEs)	Up to 5 years after the last participant is randomized
Maximum observed concentration (Cmax) of transgene level	Up to 5 years after the last participant is randomized
Time of maximum observed plasma concentration (Tmax) of transgene level	Up to 5 years after the last participant is randomized
Area under the concentration-time curve (AUC) of transgene level	Up to 5 years after the last participant is randomized
Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains	Up to 5 years after the last participant is randomized	EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL).
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains	Up to 5 years after the last participant is randomized	EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.	Up to 5 years after the last participant is randomized

Trial Locations

Locations (126)

Local Institution - 0071; 🇺🇸 Birmingham, Alabama, United States

UCLA Hematology/Oncology - Santa Monica; 🇺🇸 Los Angeles, California, United States

Local Institution - 0130; 🇺🇸 Miami, Florida, United States

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0196; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0067; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0216; 🇺🇸 Winston-Salem, North Carolina, United States

Local Institution - 0193; 🇺🇸 Cleveland, Ohio, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Local Institution - 0044; 🇺🇸 Salt Lake City, Utah, United States

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