Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial
18 Years
80 Years
Both
Multiple Myeloma
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Miles Prince, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Peter MacCallum Cancer Centre, Melbourne, Australia.
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
05/69
NCT ID:
NCT00335348
Start Date:
June 2006
Completion Date:
July 2012
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Relapse
- Bortezomib
- Dexamethasone
- Maintenance
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|
