A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
Summary
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
Arms & interventions
- BiologicalArlocabtagene Autoleucel
Specified dose on specified days
Outcome measures
Primary
Cohort 1: Best overall response (BOR) of partial response (PR) or better
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)
Time frame: Up to approximately 5 years
Secondary
BOR of partial response (PR) or better
Time frame: Up to approximately 5 years
Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)
Time frame: Up to approximately 5 years
Minimal residual disease (MRD) negative status
Time frame: Up to approximately 5 years
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)
Time frame: Up to approximately 5 years
Duration of response (DOR) assessed by an IRC
Time frame: Up to approximately 5 years
Progression-free survival (PFS)
Time frame: Up to approximately 5 years
Overall survival (OS)
Time frame: Up to approximately 5 years
Overall response rate (ORR) assessed by an Investigator
Time frame: Up to approximately 5 years
Complete response rate (CRR) assessed by an Investigator
Time frame: Up to approximately 5 years
Time to response (TTR) assessed by an Investigator
Time frame: Up to approximately 5 years
Duration of response (DOR) assessed by an Investigator
Time frame: Up to approximately 5 years
Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator
Time frame: Up to approximately 5 years
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 5 years
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 5 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to approximately 5 years
Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales
Time frame: Up to approximately 5 years
Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up
Time frame: Up to approximately 5 years
Eligibility criteria
Study locations (41)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
Los Angeles, California, 90095
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Moffitt Cancer Center
Tampa, Florida, 33612
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Iowa
Iowa City, Iowa, 52242
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
Local Institution - 0065
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Roswell Park Cancer Institute
Buffalo, New York, 14263
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599-7305
Local Institution - 0067
Charlotte, North Carolina, 28204
Oncology Hematology Care
Cincinnati, Ohio, 45242
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Oregon Health and Science University
Portland, Oregon, 97239
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107
Tennessee Oncology
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Local Institution - 0069
Austin, Texas, 78704
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
San Antonio, Texas, 78229
LDS Hospital
Salt Lake City, Utah, 84143
Virginia Oncology Associates
Norfolk, Virginia, 23502
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792