Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial|
- Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time To Progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival, defined as the time from commencement of treatment to the date of death from any cause. [ Time Frame: 2years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Bortezomib and Dexamethasone||
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 weeksDrug: Dexamethasone
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
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.
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 8006|
|Principal Investigator:||Miles Prince, MD||Peter MacCallum Cancer Centre, Melbourne, Australia.|
|Principal Investigator:||Simon Harrison, MB, BS., PhD||Peter MacCallum Cancer Centre, Australia|