Multinational phase 3 trial of low-dose lenalidomide in non-transfusion dependent patients with low risk, del(5q) myelodysplastic syndromes

Lenalidomide is the standard of care for transfusion dependent patients with del(5q) myelodysplastic syndromes (MDS). The phase 3 SintraREV trial, at 22 centers in three European countries, investigated whether early intervention with low dose lenalidomide for 2 years could delay transfusion dependency in low-risk MDS patients with anemia who are not transfusion dependent. Patients were randomized to lenalidomide 5 mg or placebo. Time to tranfusion dependency was not reached in the lenalidomide group versus 11.6 months in the placebo groups (p=0.0027). Lenalidomide significantly reduced the risk of transfusion dependency by almost 70% (HR 0.302; p=0.0046). The safety profile of lenalidomide was manageable. The authors conclude that intervention with lenalidomide for 2 years prolonged time to transfusion dependency in del(5q) low-risk MDS patients with non-transfusion dependent anemia.