A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
High-dose therapy will be performed as first line treatment. After high-dose therapy and
autologous stem cell transplantation the patients will be included and randomised. Three
month after high-dose therapy all patients will receive consolidation therapy with 6 cycles
of lenalidomide 25 mg daily for 21 days every 28 days. Afterwards patients will receive
maintenance therapy according to their assigned treatment arm. Randomisation will be
performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg
lenalidomide daily for 21 days every 28 days.Randomisation will be stratified by ISS-stage
(1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose
therapy (CR+vgPR vs PR vs MR/SD. Patients will be treated until disease progression.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Guido Kobbe, PD Dr.
Departement of Hematology, Oncology and Clinical Immunology
Germany: Federal Institute for Drugs and Medical Devices