protocolSection identificationModule nctId: NCT06297226, orgStudyIdInfo id: CA088-1000, briefTitle: Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma, acronym: QUINTESSENTIAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-10-02, completionDateStruct date: 2030-06-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: BMS-986393, outcomesModule primaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: BOR of partial response (PR) or better, secondaryOutcomes measure: BOR of complete response (CR) [including stringent complete response sCR], secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Incidence of adverse event of special interest (AESI), secondaryOutcomes measure: Incidence of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS), secondaryOutcomes measure: 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), secondaryOutcomes measure: Duration of response (DOR) assessed by an IRC, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response rate (ORR) assessed by an Investigator, secondaryOutcomes measure: Complete response rate (CRR) assessed by an Investigator, secondaryOutcomes measure: Time to response (TTR) assessed by an Investigator, secondaryOutcomes measure: Duration of response (DOR) assessed by an Investigator, secondaryOutcomes measure: Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Area under the concentration-time curve (AUC), secondaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), secondaryOutcomes measure: Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales, secondaryOutcomes measure: Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales, secondaryOutcomes measure: Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Local Institution - 0001, status: NOT_YET_RECRUITING, city: Birmingham, state: Alabama, zip: 35294-3300, country: United States, contacts name: Site 0001, role: CONTACT, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Local Institution - 0025, status: NOT_YET_RECRUITING, city: Gilbert, state: Arizona, zip: 85234, country: United States, contacts name: Site 0025, role: CONTACT, geoPoint lat: 33.35283, lon: -111.78903, locations facility: Local Institution - 0037, status: NOT_YET_RECRUITING, city: Little Rock, state: Arkansas, zip: 72205, country: United States, contacts name: Site 0037, role: CONTACT, geoPoint lat: 34.74648, lon: -92.28959, locations facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214), status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Sarah Larson, Site 0028, role: CONTACT, phone: 310-829-5471, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Local Institution - 0018, status: NOT_YET_RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Site 0018, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Colorado Blood Cancer Institute, status: RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: Tara Gregory, Site 0049, role: CONTACT, phone: 720-754-4800, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Local Institution - 0045, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33176, country: United States, contacts name: Site 0045, role: CONTACT, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Local Institution - 0029, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Site 0029, role: CONTACT, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Local Institution - 0009, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Site 0009, role: CONTACT, geoPoint lat: 33.749, lon: -84.38798, locations facility: Local Institution - 0004, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30342, country: United States, contacts name: Site 0004, role: CONTACT, geoPoint lat: 33.749, lon: -84.38798, locations facility: Local Institution - 0005, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Site 0005, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Local Institution - 0056, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Site 0056, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Local Institution - 0019, status: NOT_YET_RECRUITING, city: Iowa City, state: Iowa, zip: 52242, country: United States, contacts name: Site 0019, role: CONTACT, geoPoint lat: 41.66113, lon: -91.53017, locations facility: Local Institution - 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0035, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75390-88520, country: United States, contacts name: Site 0035, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Local Institution - 0027, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Site 0027, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Local Institution - 0055, status: NOT_YET_RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Site 0055, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Local Institution - 0050, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84143, country: United States, contacts name: Site 0050, role: CONTACT, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Local Institution - 0011, status: NOT_YET_RECRUITING, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Site 0011, role: CONTACT, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Local Institution - 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