Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients

This is a phase 2, multicenter, open-label and non-randomized study to evaluate the efficacy and safety of pomalidomide as a replacement for lenalidomide among MM patients who have failed lenalidomide-containing regimens that include more than steroids within 6 months of their last dose of lenalidomide. Pomalidomide will replace lenalidomide in a combination regimen containing an alkylating agent (cyclophosphamide), anthracycline (doxorubicin or PLD), proteasome inhibitor (bortezomib or carfilzomib) and/or a glucocorticosteroid (prednisone, dexamethasone or methylprednisolone). Pomalidomide will be administered on days 1-21 of a 28-day cycle, whereas other drugs (anthracyclines, proteasome inhibitors, steroids or alkylating agents except melphalan) will be administered using the same schedule(s), dose(s) and drug combination as the last lenalidomide-containing regimen that the patient received and failed. This study will enroll patients resistant to a lenalidomide-containing combination regimen as demonstrated by PD while being treated or that has relapsed within 6 months of the last dose of lenalidomide in their last lenalidomide-containing combination regimen or while on lenalidomide or lenalidomide and steroid maintenance therapy. Forty-five patients will be enrolled in the study. The study consists of: 1) a screening period; 2) up to eight 28-day, treatment cycles; 3) a final assessment to occur 28 days after the end of the last treatment cycle; and 4) a follow-up period. Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28-day treatment cycles, depending on the schedule of their last lenalidomide-containing regimen. Subjects are to be treated to a maximum response (lowest level of paraprotein) plus 1 additional cycle, without exceeding a total of 8 cycles, or complete 8 cycles of therapy without progressing (PD).