A phase II study of lenalidomide and prednisolone as post-autologous stem cell transplant (ASCT) maintenance therapy for patients with Multiple Myeloma incorporating residual disease monitoring.

A post stem cell transplant maintenance study with lenalidomide in combination with alternate day prednisolone. All patients will be registered prior to stem cell transplant, be planned for single high dose Melphalan-conditioned stem cell transplant and have no evidence of disease progression at re-staging 6 weeks post transplant. Oral lenalidomde will commence at a dose of 10mg daily. After 2 months following commencement, escalation or reduction of lenalidomide can be made at the discretion of the treating doctor, depending on tolerance or intolerance of the treatment. Alternate day prednisolone will commence at a dose of 50mg on alternate days with lenalidomide. No dose escalation of prednisolone is planned. Dose reductions are permitted to manage any side effects according to the study protocol. This treatment will continue until unacceptable side effects or disease relapse/progressive disease. Pre transplant, all patients will undergo disease restaging with blood tests and bone marrow aspirate. Bloods for serum storage for DNA analysis will be obtained. 6 weeks post transplant patients with adequate recovery will undergo rstaging of their disease with blood testing and bone marrow, to confirm continuing disease response. Patients with disease progression evident on re-staging will not be eligible for treatment on this study. On study, all patients will continue to be evaluated every 4 weeks with repeat blood testsfor response and monitoring until disease progression.