“Real world” outcome of lenalidomide plus dexamethasone in the setting of recurrent and refractory multiple myeloma: Extended follow-up of a retrospective multicenter study by the “rete ematologica pugliese”

• Study included patients excluded from trials because of unfavorable characteristics.
• 246 were evaluable for response and toxicity: 68% had relapsed MM, 32% refractory MM.
• OS was longer in patients receiving “lenalidomide + dexamethasone” for more than 12 months.
• Continuous treatment for at least 12 months was the best predictor of a longer OS.

This current retrospective multicenter analysis represents, to our knowledge, the first Italian study evaluating the efficacy and toxicity profile of “lenalidomide plus dexamethasone” as salvage therapy in patients with recurrent-refractory MM in the real life contest. Our study included patients who are usually excluded from clinical trials because of unfavorable baseline characteristics. Median OS was significantly longer in patients receiving “lenalidomide plus dexamethasone” for more than 12 months compared with those who had received “lenalidomide plus dexamethasone” for a shorter interval (P < 0.0001). Median OS was not affected by best response achieved (P 0.4) and age (P 0.3). Quality of response did not correlate with number of previous lines of therapy (P 0.77) and age. Higher ORRs were recorded in the patients group with relapsed MM compared to those with refractory disease, but this difference was not statistically significant (P 0.38).