Department of Medicine, Division of Blood and Marrow Transplantation, Moores Cancer Center, University of California San Diego, La Jolla, CA 92093, USA.
Myeloma Institute, University of Arkansas for Medical Sciences (UAMS), Little Rock, AR 72205, USA.
Future Oncol. 2019 May;15(13):1411-1428. doi: 10.2217/fon-2019-0013. Epub 2019 Feb 28.
With the introduction of new drugs with different mechanisms of action, multiple myeloma (MM) patients' outcomes have improved. However, the efficacy seen in clinical trials is often not seen in real-world settings and data on the effectiveness of MM therapies are needed. INSIGHT MM is a prospective, global, non-interventional, observational study that is enrolling approximately 4200 patients with newly diagnosed or relapsed/refractory MM, making it the largest study of its kind to date. The study aims to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapies chosen, clinical outcomes (response, treatment duration, time-to-next-therapy, progression-free and overall survival), safety, healthcare resource utilization and quality of life. One interim analysis has been conducted to date; current accrual is approximately 3094 patients. NCT02761187.
随着具有不同作用机制的新药的引入，多发性骨髓瘤 (MM) 患者的预后得到了改善。然而，临床试验中观察到的疗效往往在真实环境中无法看到，因此需要 MM 治疗效果的数据。INSIGHT-MM 是一项前瞻性、全球性、非干预性、观察性研究，正在招募约 4200 名新诊断或复发/难治性 MM 患者，这是迄今为止此类研究中规模最大的一项。该研究旨在描述当代真实世界中患者特征、临床疾病表现、治疗选择、临床结局（反应、治疗持续时间、下一次治疗时间、无进展和总生存）、安全性、医疗资源利用和生活质量的模式。迄今为止已进行了一次中期分析；目前的入组人数约为 3094 人。NCT02761187。
