Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has two main aims. The first is to assess whether Dexamethasone can increase the
      number of patients with who respond to Velcade.

      The second aim of this study is to see whether treating patients with relapsed multiple
      myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the
      myeloma is under control.
    

Detailed description: 
      Velcade is a new drug, which is being developed for the treatment of patients with a variety
      of cancers. In studies to date, it has been shown to be useful in the treatment of patients
      with advanced multiple myeloma whose myeloma has progressed after standard drug treatment.
      Approximately one third of them have had a response to treatment, which has lasted for
      approximately 12 months. It has been associated with improvement in symptoms from the disease
      including improvements in blood counts, fewer blood transfusions and in a lessening of bone
      pain. There is some evidence that more patients respond to Velcade when it is given together
      with a steroid drug, Dexamethasone, which is commonly used in the treatment of Myeloma, and
      you may have received in the past. Only a small number of patients have been treated with
      Velcade and Dexamethasone from the beginning of therapy. However, many more have had
      Dexamethasone added later if they have failed to respond to Velcade on its own.

      Velcade is approved in the USA and Europe by the Food and Drug Administration (FDA) for the
      treatment of patients with myeloma. However, Velcade is not approved in Australia and
      therefore its use in this study is considered experimental.

      This study has two main aims. The first is to assess whether Dexamethasone can increase the
      number of patients who respond to Velcade in the controlled setting of a clinical trial. This
      study is specifically designed for patients who have received at least one kind of standard
      treatment in the past and are now in need of further therapy because their disease has
      relapsed. The second aim of this study is to see whether treating patients with Velcade and
      Dexamethasone for a longer period of time extends the time that the myeloma is under control.
      This is known as maintenance treatment.

      Approximately 100 patients will participate around Australia.
    

Intervention name(s): Bortezomib; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks; Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks
Intervention MeSH terms: Dexamethasone; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Relapse; Bortezomib; Dexamethasone; Maintenance