The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
RECRUITINGLocal Institution - 0050
Orange, California, United States
NOT_YET_RECRUITINGLocal Institution - 0223
Washington D.C., District of Columbia, United States
Progression Free Survival (PFS)
Time frame: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Time frame: Up to 1 year after the last participant is randomized
Overall survival (OS)
Time frame: Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Time frame: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Time frame: Up to 5 years after the last participant is randomized
Complete response rate (CRR)
Time frame: Up to 5 years after the last participant is randomized
Time to response (TTR)
Time frame: Up to 5 years after the last participant is randomized
Duration of response (DOR)
Time frame: Up to 5 years after the last participant is randomized
Maximum observed concentration (Cmax) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Time of maximum observed plasma concentration (Tmax) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Area under the concentration-time curve (AUC) of transgene level
Time frame: Up to 5 years after the last participant is randomized
Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains
EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL).
Time frame: Up to 5 years after the last participant is randomized
Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains
EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment
Time frame: Up to 5 years after the last participant is randomized
Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.
Time frame: Up to 5 years after the last participant is randomized
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 0231
Jacksonville, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0130
Miami, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0228
Orlando, Florida, United States
NOT_YET_RECRUITINGWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
RECRUITINGLouisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States
RECRUITINGBoston Medical Center
Boston, Massachusetts, United States
RECRUITING...and 127 more locations