The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
187
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGNumber of participants with treatment-emergent adverse events (AEs)
Time frame: Up to 4 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 4 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 4 years
Number of participants with AEs leading to death
Time frame: Up to 4 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 4 years
Maximum observed concentration (Cmax)
Time frame: Up to 4 years
Time of maximum observed concentration (Tmax)
Time frame: Up to 4 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time frame: Up to 4 years
Overall response rate (ORR)
Time frame: Up to 4 years
Complete response rate (CRR)
Time frame: Up to 4 years
Number of participants with very good partial response (VGPR) or better
Time frame: Up to 4 years
Progression-free survival (PFS)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGUCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
RECRUITINGStanford University Medical Center
Stanford, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 9 more locations
Time frame: Up to 4 years
Overall survival (OS)
Time frame: Up to 4 years
Time to response (TTR)
Time frame: Up to 4 years
Time to complete response (TTCR)
Time frame: Up to 4 years
Duration of response (DOR)
Time frame: Up to 4 years
Duration of complete response (DOCR)
Time frame: Up to 4 years
Persistence of BMS-986453 in peripheral blood
Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)
Time frame: Up to 4 years
Expansion rate
Defined as Cmax divided by Tmax
Time frame: Up to 4 years