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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06615479




Registration number
NCT06615479
Ethics application status
Date submitted
24/09/2024
Date registered
26/09/2024

Titles & IDs
Public title
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)
Scientific title
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma
Secondary ID [1] 0 0
CA088-1007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma (RRMM) 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: Drugs - BMS-986393
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Treatment: Drugs - Daratumumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Carfilzomib

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Drugs: BMS-986393
Specified dose on specified days

Treatment: Drugs: Cyclophosphamide
Specified dose on specified days

Treatment: Drugs: Fludarabine
Specified dose on specified days

Treatment: Drugs: Daratumumab
Specified dose on specified days

Treatment: Drugs: Pomalidomide
Specified dose on specified days

Treatment: Drugs: Dexamethasone
Specified dose on specified days

Treatment: Drugs: Carfilzomib
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to 5 years after the last participant is randomized
Primary outcome [2] 0 0
Minimal residual disease (MRD)-negativity in complete response (CR)
Timepoint [2] 0 0
Up to 1 year after the last participant is randomized
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [3] 0 0
Minimal residual disease (MRD)-negative status
Timepoint [3] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [4] 0 0
Complete response rate (CRR)
Timepoint [4] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [5] 0 0
Time to response (TTR)
Timepoint [5] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [7] 0 0
The proportion of participants with adverse events (AEs)
Timepoint [7] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [8] 0 0
The proportion of participants with adverse events of special interest (AESI)
Timepoint [8] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [9] 0 0
The proportion of participants with serious adverse events (SAEs)
Timepoint [9] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [10] 0 0
Maximum observed concentration (Cmax) of transgene level
Timepoint [10] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [11] 0 0
Time of maximum observed plasma concentration (Tmax) of transgene level
Timepoint [11] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [12] 0 0
Area under the concentration-time curve (AUC) of transgene level
Timepoint [12] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [13] 0 0
Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains
Timepoint [13] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [14] 0 0
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
Timepoint [14] 0 0
Up to 5 years after the last participant is randomized
Secondary outcome [15] 0 0
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
Timepoint [15] 0 0
Up to 5 years after the last participant is randomized

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participants must have relapsed or refractory multiple myeloma (RRMM).
* Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy).
* Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
* Participants must have measurable disease during screening.
* Participants must have adequate organ function.
* Participants must have an Eastern Cooperative Oncology group performance status 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

* Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
* Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
* Participants must not need urgent treatment due to rapidly progressing MM.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/07/2032
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0142 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0140 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0139 - Adelaide
Recruitment hospital [4] 0 0
Local Institution - 0143 - Clayton
Recruitment hospital [5] 0 0
Local Institution - 0138 - Melbourne
Recruitment hospital [6] 0 0
Local Institution - 0141 - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autónoma De Buenos Aires
Country [13] 0 0
Austria
State/province [13] 0 0
Oberösterreich
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Belgium
State/province [15] 0 0
Namur
Country [16] 0 0
Belgium
State/province [16] 0 0
Oost-Vlaanderen
Country [17] 0 0
Brazil
State/province [17] 0 0
Minas Gerais
Country [18] 0 0
Brazil
State/province [18] 0 0
SAO Paulo
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czechia
State/province [24] 0 0
Brno-mesto
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 2
Country [26] 0 0
Denmark
State/province [26] 0 0
Hovedstaden
Country [27] 0 0
Denmark
State/province [27] 0 0
Midtjylland
Country [28] 0 0
Denmark
State/province [28] 0 0
Syddanmark
Country [29] 0 0
Finland
State/province [29] 0 0
Uusimaa
Country [30] 0 0
France
State/province [30] 0 0
Nord
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France
State/province [31] 0 0
Val-de-Marne
Country [32] 0 0
Germany
State/province [32] 0 0
Sachsen
Country [33] 0 0
Germany
State/province [33] 0 0
Heidelberg
Country [34] 0 0
Germany
State/province [34] 0 0
Wuerzburg
Country [35] 0 0
Greece
State/province [35] 0 0
Acha?a
Country [36] 0 0
Greece
State/province [36] 0 0
Attikí
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Debrecen
Country [39] 0 0
Israel
State/province [39] 0 0
HaMerkaz
Country [40] 0 0
Israel
State/province [40] 0 0
Tell Abib
Country [41] 0 0
Israel
State/province [41] 0 0
Yerushalayim
Country [42] 0 0
Italy
State/province [42] 0 0
Lombardia
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Italy
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Milano
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Italy
State/province [44] 0 0
Piemonte
Country [45] 0 0
Italy
State/province [45] 0 0
Bologna
Country [46] 0 0
Japan
State/province [46] 0 0
Aichi
Country [47] 0 0
Japan
State/province [47] 0 0
Chiba
Country [48] 0 0
Japan
State/province [48] 0 0
Hyogo
Country [49] 0 0
Japan
State/province [49] 0 0
Ishikawa
Country [50] 0 0
Japan
State/province [50] 0 0
Fukuoka
Country [51] 0 0
Japan
State/province [51] 0 0
Kumamoto
Country [52] 0 0
Japan
State/province [52] 0 0
Okayama
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Japan
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Osaka
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Japan
State/province [54] 0 0
Tokyo
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Japan
State/province [55] 0 0
Yamagata
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul-teukbyeolsi [Seoul]
Country [57] 0 0
Netherlands
State/province [57] 0 0
Gelderland
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Netherlands
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Limburg
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Netherlands
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Noord-Holland
Country [60] 0 0
Netherlands
State/province [60] 0 0
Groningen
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Netherlands
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Utrecht
Country [62] 0 0
Norway
State/province [62] 0 0
Oslo
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Poland
State/province [63] 0 0
Pomorskie
Country [64] 0 0
Poland
State/province [64] 0 0
Katowice
Country [65] 0 0
Poland
State/province [65] 0 0
Lublin
Country [66] 0 0
Portugal
State/province [66] 0 0
Porto
Country [67] 0 0
Romania
State/province [67] 0 0
Bucure?ti
Country [68] 0 0
Romania
State/province [68] 0 0
Ia?i
Country [69] 0 0
Saudi Arabia
State/province [69] 0 0
Riyadh
Country [70] 0 0
Singapore
State/province [70] 0 0
Central Singapore
Country [71] 0 0
Spain
State/province [71] 0 0
A Coruña [La Coruña]
Country [72] 0 0
Spain
State/province [72] 0 0
Navarra
Country [73] 0 0
Spain
State/province [73] 0 0
Salamanca
Country [74] 0 0
Sweden
State/province [74] 0 0
Huddinge
Country [75] 0 0
Switzerland
State/province [75] 0 0
Sankt Gallen
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taipei
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taichung
Country [78] 0 0
Turkey
State/province [78] 0 0
Ankara
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Cambridgeshire
Country [80] 0 0
United Kingdom
State/province [80] 0 0
England
Country [81] 0 0
United Kingdom
State/province [81] 0 0
London, City Of
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Oxfordshire
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Manchester
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Celgene Corporation
Address [1] 0 0
Country [1] 0 0

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
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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/NCT06615479