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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
Date last updated
21/11/2024

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
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno-mesto
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha 2
Country [27] 0 0
Denmark
State/province [27] 0 0
Hovedstaden
Country [28] 0 0
Denmark
State/province [28] 0 0
Midtjylland
Country [29] 0 0
Denmark
State/province [29] 0 0
Syddanmark
Country [30] 0 0
Finland
State/province [30] 0 0
Uusimaa
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France
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Nord
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France
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Rhône
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France
State/province [33] 0 0
Val-de-Marne
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Germany
State/province [34] 0 0
Bayern
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Germany
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Sachsen
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Germany
State/province [36] 0 0
Hamburg
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Germany
State/province [37] 0 0
Hannover
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Germany
State/province [38] 0 0
Heidelberg
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Germany
State/province [39] 0 0
Wuerzburg
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Greece
State/province [40] 0 0
Acha?a
Country [41] 0 0
Greece
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Attikí
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Hungary
State/province [42] 0 0
Budapest
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Hungary
State/province [43] 0 0
Debrecen
Country [44] 0 0
Israel
State/province [44] 0 0
HaMerkaz
Country [45] 0 0
Israel
State/province [45] 0 0
Tell Abib
Country [46] 0 0
Israel
State/province [46] 0 0
Yerushalayim
Country [47] 0 0
Italy
State/province [47] 0 0
Lombardia
Country [48] 0 0
Italy
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Milano
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Italy
State/province [49] 0 0
Piemonte
Country [50] 0 0
Italy
State/province [50] 0 0
Bologna
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Japan
State/province [51] 0 0
Aichi
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Japan
State/province [52] 0 0
Chiba
Country [53] 0 0
Japan
State/province [53] 0 0
Hyogo
Country [54] 0 0
Japan
State/province [54] 0 0
Ishikawa
Country [55] 0 0
Japan
State/province [55] 0 0
Fukuoka
Country [56] 0 0
Japan
State/province [56] 0 0
Kumamoto
Country [57] 0 0
Japan
State/province [57] 0 0
Okayama
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka
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Japan
State/province [59] 0 0
Tokyo
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Japan
State/province [60] 0 0
Yamagata
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Korea, Republic of
State/province [61] 0 0
Seoul-teukbyeolsi [Seoul]
Country [62] 0 0
Netherlands
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Gelderland
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Netherlands
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Limburg
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Netherlands
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Noord-Holland
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Netherlands
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Groningen
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Netherlands
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Utrecht
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Norway
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Oslo
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Poland
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Pomorskie
Country [69] 0 0
Poland
State/province [69] 0 0
Katowice
Country [70] 0 0
Poland
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Lublin
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Poland
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Lódzkie
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Portugal
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Porto
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Romania
State/province [73] 0 0
Bucure?ti
Country [74] 0 0
Romania
State/province [74] 0 0
Ia?i
Country [75] 0 0
Saudi Arabia
State/province [75] 0 0
Riyadh
Country [76] 0 0
Singapore
State/province [76] 0 0
Central Singapore
Country [77] 0 0
Spain
State/province [77] 0 0
A Coruña [La Coruña]
Country [78] 0 0
Spain
State/province [78] 0 0
Navarra
Country [79] 0 0
Spain
State/province [79] 0 0
Salamanca
Country [80] 0 0
Sweden
State/province [80] 0 0
Huddinge
Country [81] 0 0
Switzerland
State/province [81] 0 0
Sankt Gallen
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taipei
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taichung
Country [84] 0 0
Turkey
State/province [84] 0 0
Ankara
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Cambridgeshire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
England
Country [87] 0 0
United Kingdom
State/province [87] 0 0
London, City Of
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Oxfordshire
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Manchester
Country [90] 0 0
United Kingdom
State/province [90] 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
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.
Trial website
https://clinicaltrials.gov/study/NCT06615479
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06615479