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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
1/07/2025
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)
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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
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Secondary ID [1]
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CA088-1007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma (RRMM)
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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Timepoint [1]
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Up to 5 years after the last participant is randomized
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Primary outcome [2]
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Minimal residual disease (MRD)-negativity in complete response (CR)
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Assessment method [2]
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Timepoint [2]
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Up to 1 year after the last participant is randomized
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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Timepoint [1]
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Up to 5 years after the last participant is randomized
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Secondary outcome [2]
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Overall response rate (ORR)
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Assessment method [2]
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Timepoint [2]
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Up to 5 years after the last participant is randomized
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Secondary outcome [3]
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Minimal residual disease (MRD)-negative status
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Assessment method [3]
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Timepoint [3]
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Up to 5 years after the last participant is randomized
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Secondary outcome [4]
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Complete response rate (CRR)
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Assessment method [4]
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Timepoint [4]
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Up to 5 years after the last participant is randomized
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Secondary outcome [5]
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Time to response (TTR)
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Assessment method [5]
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Timepoint [5]
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Up to 5 years after the last participant is randomized
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Secondary outcome [6]
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Duration of response (DOR)
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Assessment method [6]
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Timepoint [6]
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Up to 5 years after the last participant is randomized
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Secondary outcome [7]
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The proportion of participants with adverse events (AEs)
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Assessment method [7]
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Timepoint [7]
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Up to 5 years after the last participant is randomized
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Secondary outcome [8]
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The proportion of participants with adverse events of special interest (AESI)
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Assessment method [8]
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Timepoint [8]
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Up to 5 years after the last participant is randomized
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Secondary outcome [9]
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The proportion of participants with serious adverse events (SAEs)
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Assessment method [9]
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Timepoint [9]
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Up to 5 years after the last participant is randomized
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Secondary outcome [10]
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Maximum observed concentration (Cmax) of transgene level
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Assessment method [10]
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Timepoint [10]
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Up to 5 years after the last participant is randomized
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Secondary outcome [11]
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Time of maximum observed plasma concentration (Tmax) of transgene level
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Assessment method [11]
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Timepoint [11]
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Up to 5 years after the last participant is randomized
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Secondary outcome [12]
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Area under the concentration-time curve (AUC) of transgene level
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Assessment method [12]
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0
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Timepoint [12]
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Up to 5 years after the last participant is randomized
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Secondary outcome [13]
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Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains
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Assessment method [13]
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EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL).
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Timepoint [13]
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Up to 5 years after the last participant is randomized
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Secondary outcome [14]
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Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
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Assessment method [14]
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EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
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Timepoint [14]
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Up to 5 years after the last participant is randomized
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Secondary outcome [15]
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Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
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Assessment method [15]
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Timepoint [15]
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Up to 5 years after the last participant is randomized
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/06/2032
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Actual
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Sample size
Target
440
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Local Institution - 0190 - Liverpool
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Local Institution - 0140 - Brisbane
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Royal Adelaide Hospital - Adelaide
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Monash Health - Clayton
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Recruitment hospital [6]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [7]
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Local Institution - 0191 - Melbourne
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Recruitment hospital [8]
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Local Institution - 0141 - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment outside Australia
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Tell Abib
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Milano
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Italy
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Piemonte
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Bologna
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Aichi
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Chiba
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Utrecht
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Oslo
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Porto
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Bucure?ti
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Riyadh
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Central Singapore
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Berne
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Sankt Gallen
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Taichung
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Turkey
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Celgene Corporation
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06615479
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for public queries
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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855-907-3286
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[email protected]
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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/NCT06615479
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