Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria
Miles Prince, MD
Peter MacCallum Cancer Centre, Melbourne, Australia.
Australia: Department of Health and Ageing Therapeutic Goods Administration