Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335348
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2006-06-07
Brief Title:
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN pending | None | None | None |