Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
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.
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.
Inclusion Criteria:

 -  Patient was previously diagnosed with multiple myeloma based on standard criteria and
 currently requires second or *third line therapy because of PD, defined as a 25%
 increase in M-protein, or development of new or worsening of existing lytic bone
 lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or
 relapse from CR.*Patients will only be eligible for bortezomib as 3rd line therapy if
 they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or
 revlimid alone (or with corticosteroids) as one of the 2 prior therapies.

 -  Patient is of a legally consenting age, as defined by local regulations.

 -  Patient is, in the investigator's opinion, willing and able to comply with the
 protocol requirements.

 -  Patient has given voluntary written informed consent before performance of any
 study-related procedure not part of normal medical care, with the understanding that
 consent may be withdrawn by the patient at any time without prejudice to their future
 medical care.

 -  Female patient is either post-menopausal or surgically sterilized or willing to use an
 acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine
 device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
 duration of the study.

 -  Male patient agrees to use an acceptable method for contraception for the duration of
 the study.

 -  Patient has measurable disease

 -  Patient has a Karnofsky performance status ≥60%.

 -  Patient has a life-expectancy >3 months.

 Exclusion Criteria:

 -  Primary Dexamethasone resistance

 -  Prior therapy with Bortezomib

 -  Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol

 -  Neuropathy > Grade 2 with pain by NCI-CTCAE criteria