Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408928
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2006-12-06
Brief Title:
Study on the Safety and Effectiveness of VELCADE in the Treatment of Graft-Versus-Host Disease
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Phase II Trial of VELCADE Bortezomib for Steroid Refractory Acute GVHD
Status:
COMPLETED
Status Verified Date:
2016-10
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 research study is to test the safety and effectiveness of VELCADE in the treatment of acute graft-versus-host disease GVHD that has not responded to steroids or has worsened when the steroid dose was decreased VELCADE is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances We are doing this research to determine if VELCADE may be useful in treating GVHD
Detailed Description:
Graft-versus-host disease GVHD is a serious complication after bone marrow transplantation from another donor GVHD is caused by certain cells called lymphocytes Normally these cells make immune reactions that help protect the body from foreign substances that cause infection Here these cells attack the normal tissues of the body as if they were foreign substances This interferes with the normal function of vital organs and results in their damage In GVHD these cells attack the skin liver and bowel GVHD also increases the chances of infection
VELCADE is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances We are doing this research to determine if VELCADE may be useful in treating GVHD
VELCADE is approved by the Food and Drug Administration FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on their last therapy Its effectiveness is also being tested in other cancers The dose of the drug being used in this research study is the same as what is used for the treatment of multiple myeloma It has not been approved by the FDA for use in GVHD Therefore using VELCADE for GVHD is experimental in this research study
VELCADE is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances We are doing this research to determine if VELCADE may be useful in treating GVHD
VELCADE is approved by the Food and Drug Administration FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on their last therapy Its effectiveness is also being tested in other cancers The dose of the drug being used in this research study is the same as what is used for the treatment of multiple myeloma It has not been approved by the FDA for use in GVHD Therefore using VELCADE for GVHD is experimental in this research study
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 |
|---|---|---|---|
| 2004-19 | OTHER | CCRRC | None |