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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06297226




Registration number
NCT06297226
Ethics application status
Date submitted
28/02/2024
Date registered
7/03/2024

Titles & IDs
Public title
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
Secondary ID [1] 0 0
CA088-1000
Universal Trial Number (UTN)
Trial acronym
QUINTESSENTIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Arlocabtagene Autoleucel (BMS-986393)

Experimental: Arlocabtagene Autoleucel (BMS-986393) -


Treatment: Other: Arlocabtagene Autoleucel (BMS-986393)
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best overall response (BOR) of partial response (PR) or better
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
BOR of partial response (PR) or better
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Minimal residual disease (MRD) negative status
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Duration of response (DOR) assessed by an IRC
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Progression-free survival (PFS)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Overall response rate (ORR) assessed by an Investigator
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Complete response rate (CRR) assessed by an Investigator
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Time to response (TTR) assessed by an Investigator
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Duration of response (DOR) assessed by an Investigator
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Area under the concentration-time curve (AUC)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [15] 0 0
Up to approximately 5 years
Secondary outcome [16] 0 0
Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales
Timepoint [16] 0 0
Up to approximately 5 years
Secondary outcome [17] 0 0
Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales
Timepoint [17] 0 0
Up to approximately 5 years
Secondary outcome [18] 0 0
Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up
Timepoint [18] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

* Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
* Received at least 3 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and at least 3 prior lines of therapy (LOT).
* Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
* Participants must have measurable disease during screening.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Active or history of central nervous system involvement with MM.
* Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
* Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2032
Actual
Sample size
Target
175
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0077 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0075 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0074 - Melbourne
Recruitment hospital [4] 0 0
Local Institution - 0076 - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Japan
State/province [30] 0 0
Aichi
Country [31] 0 0
Japan
State/province [31] 0 0
Hyogo
Country [32] 0 0
Japan
State/province [32] 0 0
Chiba
Country [33] 0 0
Japan
State/province [33] 0 0
Kyoto
Country [34] 0 0
Japan
State/province [34] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06297226