Study: NCT02288741

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anthracycline/dexamethasone-based induction chemotherapy
Description: 4 cycles of anthracycline/dexamethasone-based chemotherapy

Intervention type: DRUG
Group type: OTHER
Intervention: Anthracycline/dexamethasone-based induction chemotherapy
Description: 4 cycles of anthracycline/dexamethasone-based chemotherapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone for control of symptoms
Description: 2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tumor-reduction chemotherapy and stem cell mobilization
Description: 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)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tumor-reduction chemotherapy and stem cell mobilization
Description: 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)

Intervention type: DRUG
Group type: OTHER
Intervention: Tumor-reduction chemotherapy and stem cell mobilization
Description: 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)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Stem cell apheresis
Description: stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Stem cell apheresis
Description: stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Stem cell apheresis
Description: stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tandem high-dose chemotherapy (melphalan)
Description: Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tandem high-dose chemotherapy (melphalan)
Description: Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Intervention type: DRUG
Group type: OTHER
Intervention: Tandem high-dose chemotherapy (melphalan)
Description: Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Autologous peripheral blood stem cell transplantation
Description: Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Autologous peripheral blood stem cell transplantation
Description: Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Autologous peripheral blood stem cell transplantation
Description: Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)