Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study

Objective A subset analysis of the randomised, phase 3, MDS‐004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)‐defined Low‐/Intermediate (Int)‐1‐risk myelodysplastic syndromes (MDS) with isolated del(5q). Methods Patients received lenalidomide 10 mg/d (days 1–21; n = 47) or 5 mg/d (days 1–28; n = 43) on 28‐d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively. Results Rates of red blood cell‐transfusion independence (RBC‐TI) ≥182 d were higher in the lenalidomide 10 mg (57.4%; P