549
Participants
Start Date
August 31, 2001
Primary Completion Date
September 30, 2012
Study Completion Date
September 30, 2012
Anthracycline/dexamethasone-based induction chemotherapy
4 cycles of anthracycline/dexamethasone-based chemotherapy
Dexamethasone for control of symptoms
2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)
Tumor-reduction chemotherapy and stem cell mobilization
Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)
Stem cell apheresis
stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg
Tandem high-dose chemotherapy (melphalan)
Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)
Autologous peripheral blood stem cell transplantation
Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)
WiSP Wissenschaftlicher Service Pharma GmbH
OTHER