Trial Information

An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice

There is a lack of objective data relating to variation in treatment practices and resource
utilisation for Multiple Myeloma (MMY) patients between countries. This void continues to
hamper attempts to create meaningful health economic models for MMY treatment and impedes
understanding of the MMY clinical arena. This non-interventional observational study is
designed to address the problem by providing a definitive picture of routine treatment and
resource utilisation practices for MMY patients at any stage of treatment, independent of
drug(s) used and treatment line across the different countries taking part. A
non-interventional study design has been selected to facilitate data collection about
routine clinical practice. This study seeks to obtain an appropriate subset of the true
population of patients with MMY throughout Europe Middle East and Africa. Many concerns
exist when attempting to develop an unbiased study sample, including biases regarding the
selection of patients to be enrolled. Therefore, a multi-staged site and patient selection
model will be used to reduce biases associated with patient and site selection. The study
seeks to enroll at least 3,000 patients. It will deliver a description of everyday treatment
practice of MMY. Additional retrospective medical reviews will also be performed to collect
information regarding disease history. The primary objective of the study is to document and
describe current treatment regimens and disease progression of patients with MMY. Secondary
objectives of the study involve understanding the MMY patient population and its
generalisability to all treated MMY patients. Additional goals of the study are to document
and compare: (a) utilisation of current treatment regimens for MMY; (b) quality of life and
health economic parameters associated with MMY treatment regimens; (c) the safety profile of
current treatment regimens for MMY and the impact on resource utilisation; (d) the
effectiveness of current treatment regimens for MMY. The study will collect prospective data
on efficacy, outcomes, health economic and safety parameters for all patients whenever
available. The resulting database will allow future health economic,
pharmaco-epidemiological, and outcomes research, and provide important data from the
clinical arena. At least 3000 patients will be recruited to this study. As this is an
observational study, the decision of patients to take part in this study will not have any
impact on the care they are receiving. All treatment decisions will be made at the
discretion of the participating physicians. Only data available from routine clinical
practice will be collected. There are two phases of data collection in this study: (a) at
baseline, the patient's historical treatment and resource utilisation data, where possible
stretching back to diagnosis, will be recorded via electronic data capture; (b) following
the baseline visit, the patient will enter a prospective data collection phase where data
will be collected at least every three months. At each data collection point, all changes
since the previous data collection point will be collected. Prospective data collection will
continue until the study is complete or the patient is withdrawn from the study. Data will
continue to be captured until three years after the last patient is recruited to the study.
Interim analyses will be conducted at least annually to update the current data. To monitor
the safety profile of MMY treatment related to a Johnson and Johnson product, any unwanted
effects that occur during the MMY treatment will be recorded Observational Study - No
investigational drug administered