Borad Abhilasha, Saeed Hamnah, Toscani Michael, Barone Joseph, Weber Paul
Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, NJ, USA.
Robert Wood Johnson Medical School at Rutgers, The State University of New Jersey, NJ, USA.
J Oncol Pharm Pract. 2020 Sep;26(6):1475-1481. doi: 10.1177/1078155220934162. Epub 2020 Jul 1.
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.
多发性骨髓瘤的诊断平均年龄和中位年龄在70至73岁之间，63%的患者年龄超过65岁。3期临床试验旨在研究目标疾病人群中的疗效，并且旨在拥有最具代表性的受试者群体。本综述的目的是确定参与旨在治疗多发性骨髓瘤的介入性3期临床试验的受试者的年龄分布，并确定这些试验是否涵盖了该疾病的真实年龄分布。为完成本综述，在clinicaltrials.gov（一个列出临床试验的全国性公开可用资源）上搜索了已报告结果的3期多发性骨髓瘤研究试验。确定了每个试验中报告的受试者平均年龄或中位年龄，并计算了这些值的调整平均值。评估了来自81项临床试验的数据，其中42项试验报告的平均年龄为65.78岁，15项试验报告的平均中位年龄为63.29岁。基于这些结果，确定本研究中报告的临床试验纳入的患者比该疾病的真实年龄分布中的患者更年轻。多发性骨髓瘤老年患者群体的研究存在未满足的需求，这可能会阻碍临床试验结果的普遍性和实用性。
