Velcade (Bortezomib) Consolidation After Transplant (VCAT)

• The number and percent of patients with complete response (CR) + very good partial response (VGPR) [ Time Frame: After approximately 12 months of consolidation therapy ] [ Designated as safety issue: No ]
  

• Complete response (CR) rate [ Time Frame: From time of screening up to 12 months post-randomization ] [ Designated as safety issue: No ]
  Complete response (CR) is defined by international myeloma working group (IMWG) criteria for multiple myeloma.
  
  
• Stringent complete response (sCR) rate [ Time Frame: From time of screening up to 12 months post-randomization ] [ Designated as safety issue: No ]
  Stringent complete response (sCR) is defined by IMWG criteria for multiple myeloma.
  
  
• Progression-free survival (PFS) rate [ Time Frame: From time of randomization up to 3 years post-randomization ] [ Designated as safety issue: No ]
  Progression-free survival (PFS) is defined by IMWG criteria calculated as the time between randomization to disease progression or death (regardless of cause), whichever comes first.
  
  
• Disease-free survival (DFS) rate [ Time Frame: From time of randomization up to 3 years post-randomization ] [ Designated as safety issue: No ]
  Disease-free survival (DFS) is defined by the duration from the start of CR to the time of relapse from CR. Disease-free survival applies only to subjects in CR.
  
  
• Overall survival (OS) rate [ Time Frame: From time of randomization to up to 3 years post-randomization ] [ Designated as safety issue: No ]
  Overall survival (OS) is defined as the time between randomization and death (regardless of cause).
  
  

This is an open-label (patients will know the identity of study treatments), randomized (patients will be assigned by chance to different treatments) study of bortezomib administered as consolidation therapy (therapy given once a remission is achieved) with thalidomide and prednisolone versus thalidomide and prednisolone alone in previously untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells, a type of white blood cell present in your bone marrow. Patients in this study will receive initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure where patients receive an infusion of immature blood cells [stem cells] from their own body to replenish the body's supply of healthy blood-forming cells) before randomization to one of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression and prednisolone on alternate days continued indefinitely or until disease progression) or Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until disease progression and prednisolone on alternate days, continued indefinitely or until disease progression.

Throughout the study, the patient's response to therapy will be assessed according to protocol-defined efficacy evaluations and by implementing defined disease response criteria (International Myeloma Working Group [IMWG] criteria). Safety will be evaluated throughout the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be conducted from time of randomization to 3 years post-randomization.

Two interim analyses are planned. The final analysis will be conducted after all patients have completed 12-month consolidation treatment phase or discontinued. The primary endpoint of number and percent of patients with complete response and very good partial response defined by IMWG criteria for multiple myeloma will be examined in the interim and final analyses after approximately 12 months of consolidation therapy. At the completion of the study, updated analyses of PFS and OS will be performed.