Age demographics of subjects enrolled in interventional phase 3 multiple myeloma clinical trials

Abstract

<jats:p> The mean and median ages of diagnosis of multiple myeloma range from 70 to 73 years old, with 63% of patients being over the age of 65. Phase 3 clinical trials are designed to study efficacy in the target disease population and are meant to have the most representative subject pool. The purpose of this review is to identify the age demographic of subjects participating in interventional phase 3 clinical trials that aim to treat multiple myeloma and to determine if they encompass the true age demographic of the disease. To complete this review, a search of phase 3 multiple myeloma research trials with reported results was conducted on clinicaltrials.gov, a national, publicly available resource listing clinical trials. Reported mean or median ages of subjects were identified for each trial, and adjusted averages of these values were calculated. Data from 81 clinical trials were assessed, with 42 trials reporting an average mean age of 65.78 years and 15 trials reporting an average median age of 63.29 years. Based on these results, it was determined that the clinical trials reported in this study enrolled patients that were younger than the true age demographic of the disease. There is an unmet need in research in the older population of patients with multiple myeloma, and this may hinder the generalizability and utility of clinical trial results. </jats:p>

Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials

“…Between 2014 and 2017, 39% of the 3612 participants were ≥ 65 years of age [ 11 ]. Borad et al reported younger patients being enrolled more than the true demographic of multiple myeloma in phase 3 clinical trials [ 12 ]. Randomized clinical trials observing drug interventions for ischemic heart disease starting from 2006 and after to measure the exclusion of the elderly population were examined.…”