NSMM-5001, the INSIGHT-MM study
Research type
Research Study
Full title
A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients - the INSIGHT-MM study
IRAS ID
204062
Contact name
Gordon Cook
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc.
Duration of Study in the UK
8 years, 1 months, 26 days
Research summary
Myeloma, also known as multiple myeloma (MM), is a cancer arising from plasma cells, a type of white blood cell which is made in the bone marrow. Bone marrow is the ‘spongy’ material found in the centre of the larger bones in the body. The bone marrow is where all blood cells are made. In Europe, the estimated annual incidence in 2012 was 38,900 new cases and 24,300 deaths. The incidence of MM is increasing slowly; this may be related to an aging population, as well as to increasing obesity rates. However, deaths from MM are decreasing. Although advances in chemotherapy and novel agents have improved the prognosis and increased disease-free survival for patients with MM, currently available data on presentation, treatment patterns, and outcomes for MM at the global level are limited.
The main goals of this study include conducting non-interventional, observational research to gain a better understanding of the disease and and clinical outcomes associated with MM and the impact of treatment on safety, effectiveness, and quality of life. No modification of standard care will be assigned, the assignment of an eligible patient to a particular therapy shall be decided by the treating healthcare provider. Patients will be asked to complete a patient survey and validated questionnaires during the course of the study, using a secure electronic data collection system.
Information regarding patient characteristics, diagnosis, and previous treatments will be recorded. MM management data and safety data will be obtained as part of routine office visits.
Patients will be enrolled over a period of 3 years, and each included patient will be evaluated and followed-up for a period of at least 5 years, until death, or the end of the study, whichever comes first. The study will attempt to enroll a minimum of 5000 patients globally.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0289
Date of REC Opinion
18 Jul 2016
REC opinion
Further Information Favourable Opinion