Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358020
Status:
COMPLETED
Last Update Posted:
2006-12-04
First Post:
2006-07-27
Brief Title:
Melphalan Prednisone Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
A Phase II Multi-Center Open Label Study Of Melphalan Prednisone Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2006-11
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:
The purpose of this study is to evaluate the safety and the efficacy of the association of MelphalanPrednisoneThalidomideVELCADE MPTV as salvage treatment in advanced and refractory myeloma patients This association might further increase the response rate achieved by the standard oral MP regimen
Detailed Description:
In Multiple Myeloma MM patients the conventional treatment is the oral combination melphalan and prednisone MP thalidomide has been widely used in myeloma it has been proved clinical effective in refractory myeloma patients it acts sinergistically in association with dexamethasone In newly diagnosed patients the combination oral MP plus thalidomide increased the partial and complete response rateBortezomib represents a novel class of anti-cancer drugs it is active in patient with multiple myeloma who are refractory to conventional chemotherapy In a preliminary report the combination of VELCADE and Thalidomide induced a remarkable 60 PR rate in advanced refractory myeloma patients This study will evaluate the safety and the efficacy of the association of Melphalan PrednisoneThalidomideVELCADE MPTV as salvage treatment in advanced and refractory myeloma patients This association might further increase the response rate achieved by the standard oral MP regimen
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 |
|---|---|---|---|
| MPTV | None | None | None |