Elranatamab, a bispecific antibody that targets B-cell maturation antigen (BCMA), received accelerated approval by the U.S. Food and Drug Administration (FDA) in 2023 for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy. Although clinical trials provide critical efficacy and safety data, real-world evidence (RWE) is needed to understand treatment patterns, effectiveness, and safety outcomes in broader patient populations outside of controlled trial settings. This study aims to fill this evidence gap by comprehensively characterizing the treatment patterns, real-world overall response rate (rwORR), and adverse events (AEs) among RRMM patients treated with elranatamab.
This is a retrospective, observational cohort study using de-identified electronic health record (EHR)-derived data from the Flatiron Health Research database (FHRD). The study will evaluate real-world patient characteristics, treatment patterns, rwORR, and AEs among RRMM patients treated with elranatamab and in specific sub-populations of interest. The FHRD is a longitudinal database derived from EHRs from cancer care providers across the United States.
Study population is US patients diagnosed with Multiple Myeloma (MM) on or after January 1, 2013, who received elranatamab treatment. Approximately 120 patients' data is expected to be included in the study.
Descriptive statistics will be used to summarize demographics, clinical characteristics, treatment patterns, incidence of AEs, and rwORR. For continuous variables, the descriptive statistics will include medians, interquartile range (IQR), means, standard deviations, and minimum and maximum values (as applicable). For categorical variables, frequencies and percentages will be generated. The number of patients with missing data will be reported for all variables. Levels of categorical variables may be combined to account for small sample sizes.