INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma

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. Trial registration number: NCT02761187 Lay abstract: Survival of patients with myeloma, a type of bone marrow cancer affecting the production of healthy blood cells, has improved due to the development and approval of new treatments. Treatments are approved based on clinical trials; however, limited data are available that confirm the effectiveness of these same treatments in real-world routine clinical practice. INSIGHT MM is a large, global study that will follow approximately 4200 myeloma patients from real-world settings for a minimum of 5 years, describing their clinical characteristics, type of therapy received and their response to treatment, including survival and toxicity. This review describes the study aims and methods. [GRAPHICS]