High-dose lenalidomide maintenance therapy in adult acute myeloid leukaemia (AML)

Lenalidomide has a variety of reported mechanisms in blood malignancy, including activation of immune cells and anti-proliferative effects on tumor cells and modulation of the bone marrow microenvironment. Currently approved doses of lenalidomide use up to 25 mg for 21 days out of 28. A recent pilot study in older AML patients used higher and continuous doses of lenalidomide (50mg lenalidomide for 28 days x 2 cycles followed by 10 mg daily for 12 months). This resulted in a 30% complete response rate. This schedule was well tolerated in an elderly AML population. Therefore, lenalidomide at higher doses has substantial activity in AML and deserves further exploration. To explore the potential clinical value of lenalidomide in prolonging remission in adult AML after chemotherapy, this multicentre Investigator Initiated Australasian study will first investigate the safety and tolerability of increasing doses of lenalidomide (10-50mg per day for 28 days for 2 months) followed by 10mg per day for 10 months.