Open-label, multicenter, randomized, phase II study of Pomalidomide with Dexamethasone in relapsed or refractory, progressive multiple myeloma that has not previously achieved at least a partial response to Bortezomib and Lenalidomide – IFM 2009-02

PRIMARY OUTCOME: Main Objective: To determine the response rate to the combination of pomalidomide and dexamethasone in patients with relapsed or refractory, progressive MM who have not previously achieved at least a partial response to bortezomib and lenalidomide. Primary endpoint(s): The response rate (partial response + complete response) to the combination of pomalidomide and dexamethasone for the study population, using the International Myeloma Working Group (IMWG) response criteria. Secondary Objective(s): - To determine the response and tolerability profile of two pomalidomide administration methods; - To determine the toxicity profile of pomalidomide and dexamethasone; - To determine the time to response and duration of response of the pomalidomide and dexamethasone combination. - determine the time to progression after pomalidomide and dexamethasone; - evaluate the overall survival of pomalidomide and dexamethasone; - evaluate response rates according to cytogenetic profiles; INCLUSION CRITERIA: - The patient must be able to understand and voluntarily sign informed consent - Must be able to adhere to the study visit schedule and other protocol requirements - Age > 18 years - Life expectancy > 6 months (ECOG <3) - Patients must have symptomatic and progressive multiple myeloma following treatment with bortezomib and/or lenalidomide - Patients must have a clearly detectable and quantifiable monoclonal component - ECOG performance status assessed as 0, 1, or 2 - Adequate bone marrow function within 72 hours prior to treatment, without transfusion or growth factor support - Adequate organ function, including creatinine clearance ≥ 50 mL/min - Treatment-free period of at least 2 weeks after any other antitumor therapy, including treatment Investigational – Subject who may be taking antithrombotics