Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial
Patients were recruited prior to receiving induction therapy, and randomization in a 1:1
ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted
of the following four phases:
1. induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD)
every 21-28 days: vincristine 0.4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg
daily for 4 days;
2. cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell
mobilization;
3. melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT);
4. Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral
dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus
thalidomide 200 mg daily by mouth) for 12 months or until disease progression.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free survival
Primary endpoint: progression free survival (PFS) PFS was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
36 months
No
Angelo Maiolino, MD, PhD
Principal Investigator
Federal University of Rio de Janeiro
Brazil: Ethics Committee
GBRAM0001
NCT01296503
October 2003
December 2010
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