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Brief Title: Tandem High Dose Melphalan Versus Triple Intermediate Dose Melphalan and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy
Official Title: 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
Study ID: NCT00205764
Brief Summary: This is an international,multicenter, prospective, open, double randomised and controlled phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus triple intermediate dose Melpahaln in newly-diagnosed myeloma patients
Detailed Description: 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.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Wilhelminenspital, 1st Medical Department-center for oncology and hematology, Vienna, , Austria
Name: Heinz Ludwig, MD,Univ.Prof
Affiliation: Wilhelminenspital 1st medical dep.-center for oncology and hematology
Role: PRINCIPAL_INVESTIGATOR