nctId: NCT06297226 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 overallStatus: RECRUITING date: 2024-03-21 date: 2026-10-02 date: 2030-06-04 date: 2024-03-07 date: 2024-03-29 name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: BMS-986393 measure: Best overall response (BOR) measure: Best overall response (BOR) measure: BOR of partial response (PR) or better measure: BOR of complete response (CR) [including stringent complete response sCR] measure: Incidence of adverse events (AEs) measure: Incidence of serious adverse events (SAEs) measure: Incidence of adverse event of special interest (AESI) measure: Incidence of participants with clinical laboratory abnormalities measure: Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS) 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) measure: Duration of response (DOR) assessed by an IRC measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall response rate (ORR) assessed by an Investigator measure: Complete response rate (CRR) assessed by an Investigator measure: Time to response (TTR) assessed by an Investigator measure: Duration of response (DOR) assessed by an Investigator measure: Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator measure: Maximum observed plasma concentration (Cmax) measure: Area under the concentration-time curve (AUC) measure: Time of maximum observed plasma concentration (Tmax) measure: Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales measure: Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales measure: Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Local Institution - 0001 status: NOT_YET_RECRUITING city: Birmingham state: Alabama zip: 35294-3300 country: United States name: Site 0001 role: CONTACT lat: 33.52066 lon: -86.80249 facility: Local Institution - 0025 status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85234 country: United States name: Site 0025 role: CONTACT lat: 33.35283 lon: -111.78903 facility: Local Institution - 0037 status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72205 country: United States name: Site 0037 role: CONTACT lat: 34.74648 lon: -92.28959 facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Sarah Larson, Site 0028 role: CONTACT phone: 310-829-5471 lat: 34.05223 lon: -118.24368 facility: Local Institution - 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