Spots Global Cancer Trial Database for Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

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Trial Identification

Brief Title: Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

Official Title: Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial

Study ID: NCT01296503

Conditions

Multiple Myeloma

Interventions

Thalidomide plus dexamethasone

Dexamethasone

Study Description

Brief Summary: This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.

Detailed Description: 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.