A multicenter, open-label, randomized phase II study has demonstrated clinical efficacy and safety of treatment with pomalidomide (POM), with or without low-dose dexamethasone (LoDEX), in patients with relapsed and refractory multiple myeloma (RRMM). The POM+LoDEX combination was generally well tolerated, and it significantly increased the median progression-free survival (4.2 months) when compared with POM alone (2.7 months). The efficacy of POM+LoDEX was not affected by prior treatment indicating that this regimen represents an important new treatment option for patients with RRMM who had received multiple prior therapies.