Efficacy and safety profile of long-term exposure to lenalidomide in patients with recurrent multiple myeloma

BACKGROUND: Lenalidomide in combination with dexamethasone (Len=Dex) is indicated for patients with recurrent=refractory multiple myeloma (RRMM) who were treated with 1 prior therapy until evidence of disease progression. The objective of the current study was to determine the efficacy and safety profile of long-term exposure to Len=Dex. METHODS: A total of 50 patients with RRMM who were treated with long-term Len for 2 years from 2 Intergroupe Francophone du My� (IFM) centers (Lille and Nancy) were included in the current study. RESULTS: The median age of the patients was 58 years, with 30% of the patients aged >65 years, 49% having an International Staging System stage of 2 and 3, 12% having severe renal insufficiency, and 8% demonstrating an adverse result on fluorescence in situ hybridization. Approximately 56% of the patients received treatment with Len=Dex for 3 years. The median duration of treatment with Len=Dex was 3 years (range, 2 years-7 years). The response rates for partial response or better and very good partial response or better for the overall cohort were 96% and 74%, respectively, which is similar to patients exposed to Len for 3 years. With a median follow-up of 4 years, 19 (38%) patients had stopped treatment with Len=Dex. The time to disease progression rate at 37 months was 78% and 91%, respectively, in patients exposed to Len for 2 years to