FDA-IMS Joint Workshop: Defining Patient Populations for Clinical Studies in Multiple Myeloma

Outcomes for patients with multiple myeloma have improved with approval of several therapies. Despite this MM, remains incurable. Recent results have also highlighted the heterogeneity in outcomes in patients with multiple myeloma. Improved understanding of the clinical and disease specific prognostic factors and the availability of multiple classes of therapies has necessitated discussions on patient populations for evaluation in clinical trials of novel therapies. Additionally, as new therapies are moved into earlier lines, it is important to evaluate the appropriateness of the control arms for clinical trials.

This workshop is intended to discuss disease setting considerations in MM, with a focus on defining patient populations for enrollment onto clinical trials for MM. This meeting will bring together representatives from the physician community, patients, pharmaceutical industry and regulatory scientists.

Goals and Objectives
– Discuss eligibility criteria for MM clinical trials in different disease settings
– Discuss considerations in defining patient populations
– Review common goals and methods for clinical trial conduct

Preliminary Agenda