Department of Hematological Malignancies and Cellular Therapeutics, University of Kansas, Kansas City, Kansas, USA.
Department of Medicine, University of Toledo, Toledo, OH, USA.
Leuk Lymphoma. 2021 Jun;62(6):1386-1395. doi: 10.1080/10428194.2020.1867725. Epub 2021 Jan 8.
Clinical trials may be inconsistent in their enrollment and reporting of patients with multiple myeloma (MM) who have renal insufficiency (RI). We performed a systematic review of all MM randomized clinical trials (RCT) from 2005-2019 to evaluate reporting of prevalence, eligibility criteria and outcomes of patients with RI and MM. One-hundred and twenty-three RCTs were included. Only 30% of studies clearly reported on the proportion of patients who had RI. Only 68.2% reported eligibility criteria pertaining to RI, with no uniformity in the reported criteria. The relative risk (RR) of disease progression or death in patients with RI was higher than those without, RR of 1.20 (1.003-1.431) for relapsed/refractory and 1.07 (1.001-1.046) for newly diagnosed. There is inconsistent reporting and enrollment of patients with RI on MM RCT's. We advocate for higher enrollment of patients with RI and transparent reporting of their eligibility criteria and outcomes.
临床试验在纳入和报告肾功能不全 (RI) 的多发性骨髓瘤 (MM) 患者方面可能存在不一致性。我们对 2005 年至 2019 年所有 MM 随机临床试验 (RCT) 进行了系统评价,以评估 RI 和 MM 患者的患病率、纳入标准和结局的报告情况。共纳入 123 项 RCT。只有 30%的研究明确报告了 RI 患者的比例。仅有 68.2%的研究报告了与 RI 相关的纳入标准,但报告的标准不统一。RI 患者的疾病进展或死亡的相对风险 (RR) 高于无 RI 患者,RR 分别为 1.20 (1.003-1.431) 复发/难治性和 1.07 (1.001-1.046) 新诊断。在 MM RCT 中,RI 患者的报告和纳入存在不一致性。我们主张更高比例的 RI 患者纳入,并对其纳入标准和结局进行透明报告。