Adherence to Lenalidomide Treatment in Multiple Myeloma - Prevalence, Characteristics and Clinical Significance

Study Hypothesis: We hypothesize that non-adherence to lenalidomide in MM patients is associated with decreased overall response rates and shorter time to progression (TTP).

Study Objectives:

Primary Objective: To evaluate the association between non-adherence to lenalidomide in MM patients and the overall response rate at 6 months.

Secondary Objectives: 1) To evaluate the prevalence of non-adherence to lenalidomide in MM patients, and independent risk factors thereof. 2) To validate the utility of questionnaires assessing adherence in identifying MM patients at risk for lenalidomide non-adherence.3) To assess the association between non-adherence to lenalidomide and long-term response, measured as time to progression (TTP) at 18 months.

Background: Lenalidomide-based regimens are a key component of the armamentarium for initial treatment in newly diagnosed multiple myeloma patients. Real-life data shows CR rates that are comparable to or slightly higher 1than those seen in prospective clinical trials. This variable response is a result of differences in clinical settings and patient and disease characteristics, but in theory, also may be due to variable adherence to lenalidomide. The development of oral anticancer therapies, such as lenalidomide, represents a significant step forward in oncology care by providing patients with convenient treatment of proven clinical efficacy, but also presents healthcare professionals with the challenge of monitoring and maintaining patients' adherence to this therapy.