Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00358020
Status:
COMPLETED
Last Update Posted:
2006-12-04
First Post:
2006-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
Sponsor:
University of Turin, Italy
Organization:
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 Melphalan/Prednisone/Thalidomide/VELCADE (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 rate.Bortezomib 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/ Prednisone/Thalidomide/VELCADE (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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MPTV | None | None | View |