Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

• Progression Free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  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.
  
  

• Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  Secondary endpoints: overall survival (OS) was defined as the interval from randomization to death (or the last follow-up for surviving patients). For patients who were not randomized, OS was calculated from the date of diagnosis until the date of death or last follow-up.
  
  
• safety of thalidomide [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  The number of patients experiencing adverse events grade 3 or 4 were compared between treatment arms. Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT). Adverse events evaluations were performed at the time of response assessment and whenever a new clinical manifestation suggestive of toxicity appeared.
  
  

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.