Multiple Myeloma Clinical Trial
— QUINTESSENTIALOfficial title:
A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | June 4, 2030 |
| Est. primary completion date | October 2, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria - Documented diagnosis of multiple Mmyeloma (MM) as per International Myeloma Working Group (IMWG) criteria. - Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and anti-B cell maturation antigen (BCMA) therapy], and at least 3 prior lines of therapy (LOT). - Documented disease progression during or after their last anti-myeloma regimen as per IMWG. - Participants must have measurable disease during screening. - Have measurable disease during screening. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria - Active or history of central nervous system involvement with MM. - Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. - Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0020 | Calgary | Alberta |
| Canada | Local Institution - 0021 | Montréal | Quebec |
| United States | Local Institution - 0004 | Atlanta | Georgia |
| United States | Local Institution - 0009 | Atlanta | Georgia |
| United States | Local Institution - 0001 | Birmingham | Alabama |
| United States | Local Institution - 0036 | Boston | Massachusetts |
| United States | Local Institution - 0039 | Boston | Massachusetts |
| United States | Local Institution - 0046 | Buffalo | New York |
| United States | Local Institution - 0031 | Chapel Hill | North Carolina |
| United States | Local Institution - 0005 | Chicago | Illinois |
| United States | Local Institution - 0056 | Chicago | Illinois |
| United States | Local Institution - 0054 | Cincinnati | Ohio |
| United States | Local Institution - 0032 | Columbus | Ohio |
| United States | Local Institution - 0035 | Dallas | Texas |
| United States | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | Local Institution - 0025 | Gilbert | Arizona |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Local Institution - 0037 | Little Rock | Arkansas |
| United States | UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) | Los Angeles | California |
| United States | University Hospital and UW Health Clinics | Madison | Wisconsin |
| United States | Local Institution - 0045 | Miami | Florida |
| United States | Local Institution - 0043 | Nashville | Tennessee |
| United States | Local Institution - 0034 | New Brunswick | New Jersey |
| United States | Local Institution - 0002 | New York | New York |
| United States | Local Institution - 0003 | New York | New York |
| United States | Local Institution - 0038 | Portland | Oregon |
| United States | Local Institution - 0033 | Rochester | Minnesota |
| United States | Local Institution - 0010 | Saint Louis | Missouri |
| United States | Local Institution - 0026 | Saint Matthews | Kentucky |
| United States | Local Institution - 0050 | Salt Lake City | Utah |
| United States | Local Institution - 0055 | San Antonio | Texas |
| United States | Local Institution - 0018 | San Francisco | California |
| United States | Local Institution - 0011 | Seattle | Washington |
| United States | Local Institution - 0029 | Tampa | Florida |
| United States | Local Institution - 0016 | Westwood | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Best overall response (BOR) | The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT) | Up to approximately 5 years | |
| Secondary | Best overall response (BOR) | The number and percent of participants achieving complete response (CR) [including stringent complete response sCR] in quadruple class exposed participants received at least 4 prior lines of therapy (LOT) | Up to approximately 5 years | |
| Secondary | BOR of partial response (PR) or better | The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT | Up to approximately 5 years | |
| Secondary | BOR of complete response (CR) [including stringent complete response sCR] | The number and percent of participants achieving CR (including sCR) in quadruple class exposed participants received at least 3 prior LOT | Up to approximately 5 years | |
| Secondary | Incidence of adverse events (AEs) | Up to approximately 5 years | ||
| Secondary | Incidence of serious adverse events (SAEs) | Up to approximately 5 years | ||
| Secondary | Incidence of adverse event of special interest (AESI) | Up to approximately 5 years | ||
| Secondary | Incidence of participants with clinical laboratory abnormalities | Up to approximately 5 years | ||
| Secondary | Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS) | Up to approximately 5 years | ||
| Secondary | 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) | Up to approximately 5 years | ||
| Secondary | Duration of response (DOR) assessed by an IRC | Up to approximately 5 years | ||
| Secondary | Progression-free survival (PFS) | Up to approximately 5 years | ||
| Secondary | Overall survival (OS) | Up to approximately 5 years | ||
| Secondary | Overall response rate (ORR) assessed by an Investigator | Up to approximately 5 years | ||
| Secondary | Complete response rate (CRR) assessed by an Investigator | Up to approximately 5 years | ||
| Secondary | Time to response (TTR) assessed by an Investigator | Up to approximately 5 years | ||
| Secondary | Duration of response (DOR) assessed by an Investigator | Up to approximately 5 years | ||
| Secondary | Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator | Up to approximately 5 years | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to approximately 5 years | ||
| Secondary | Area under the concentration-time curve (AUC) | Up to approximately 5 years | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to approximately 5 years | ||
| Secondary | Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales | Up to approximately 5 years | ||
| Secondary | Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales | Up to approximately 5 years | ||
| Secondary | Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up | Up to approximately 5 years |
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