The Food and Drug Administration (FDA) has approved Revlimid (lenalidomide) plus dexamethasone in newly diagnosed patients with multiple myeloma based on findings from the phase 3 FIRST trial. In the study, treatment with continuous Revlimid plus low-dose dexamethasone reduced the risk of disease progression by 28 percent compared with the MPT regimen of melphalan, prednisone and Thalomid (thalidomide). Median progression-free (PFS) survival was improved by 4.3 months with continuous Revlimid /dexamethasone versus MPT. "The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease,” said Kenneth Anderson, director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber/Brigham and Women’s Cancer Center. “We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival." The international, three-arm FIRST trial randomized 1623 patients in to continuous Revlimid /dexamethasone until disease progression, 18 cycles of Revlimid /dexamethasone or 12 cycles of MPT. Treatment cycles were 28 days. Median patient age in all three arms was 73 years. Patients were stratified by age, disease stage and country. The primary endpoint was PFS with continuous Revlimid versus MPT. Secondary end points included overall survival (OS), overall response rate (ORR), time to response, duration of response and safety. PFS was 25.5 months with continuous Revlimid, 20.7 months with the fixed Revlimid regimen and 21.2 months with MPT. Compared with the MPT and fixed-course arms, continuous Revlimid led to a 28 percent and 30 percent reduction, respectively, in the risk of disease progression or death. Based on a March 3, 2014, interim OS analysis, continuous Revlimid reduced the risk of death by 25 percent compared with the control arm (58.9 versus 48.5 months). The authors did note that the benefit of continuous treatment was not as clear in individuals with a poor prognostic outlook. The most common adverse events (AEs) in the continuous Revlimid arm compared with the MPT arm were diarrhea, anemia and neutropenia. Moderate to severe side effects reported in the continuous Revlimid arm included neutropenia, anemia and thrombocytopenia. Revlimid was previously approved for use in combination with dexamethasone for patients with multiple myeloma following one prior therapy. The drug also has approved indications for mantle cell lymphoma and myelodysplastic syndromes.