At a glance
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Phase III-study for Evaluation of Induction Therapy Before Stem Cell Mobilization and Tandem High-dose Melphalan in Multiple Myeloma Patients 60 to 70 Years of Age
In Brief
A Phase 3 clinical trial evaluating Anthracycline/dexamethasone-based induction chemotherapy, Dexamethasone for control of symptoms, and 4 other interventions for Multiple Myeloma. Completed, enrolled 549 participants.
Detailed Summary
Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1) or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was scheduled for all patients.
Study Details
Timeline
Interventions
4 cycles of anthracycline/dexamethasone-based chemotherapy
2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)
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 in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg
Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)
Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)