Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

549

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Multiple Myeloma
Interventions
DRUG

Anthracycline/dexamethasone-based induction chemotherapy

4 cycles of anthracycline/dexamethasone-based chemotherapy

DRUG

Dexamethasone for control of symptoms

2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)

DRUG

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)

PROCEDURE

Stem cell apheresis

stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

DRUG

Tandem high-dose chemotherapy (melphalan)

Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

PROCEDURE

Autologous peripheral blood stem cell transplantation

Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

All Listed Sponsors
lead

WiSP Wissenschaftlicher Service Pharma GmbH

OTHER

NCT02288741 - Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy | Biotech Hunter | Biotech Hunter