Randomised, Non-blind, Parallel Group Study to Compare Tandem High Dose Melphalan (200mg/m²) Versus Triple Intermediate Dose Melphalan (100mg/m²) and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Patients will be enrolled into this protocol before start of Induction therapy which
consists of 3 cycles or VAD with a 4 week interval followed by 1 cycle of IEV after which
stem cell harvesting is performed. After stem cell harvesting is completed Patients will be
randomised to one of the high dose therapy arms after response evaluation (Complete
remission, Partial remission or stable disease). One group is receiving 2 Cycles of
Melphalan 200mg/m² each followed by stem cell transplantation, the other group is receiving
3 Cycles of Melphalan 100mg/m² also followed by stem cell transplantation each time.
After completing high dose therapy patients will be randomised into Maintenance responding
with CR, PR or SD. The maintenance therapy will be continued until relapse or progression of
disease as defined by the response criteria.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to treatment failure
Heinz Ludwig, MD,Univ.Prof
Wilhelminenspital 1st medical dep.-center for oncology and hematology
Austria: Federal Ministry for Health and Women