Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083915
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2004-06-03
Brief Title:
DTPACE Followed by Tandem Transplant With Melphalan MEL 200 Versus MELDexamethasoneThalidomide DT PlatinolAdriamycinEtoposide PACE Hybrid and DTPACE Consolidation
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
University of Arkansas UARK 2001-12 A Phase III Study of DTPACE Followed by Tandem Transplant With MEL 200 Versus MELDTPACE Hybrid and DTPACE Consolidation in Patients With Active Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-10
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 study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone Thalidomide Cisplatin or Platinol Adriamycin or doxorubicin Cyclophosphamide and Etoposide Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan compared to melphalan alone
Detailed Description:
To evaluate in a randomized phase III clinical trial in previously treated multiple myeloma patients whether angio-chemotherapy with DT PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of complete remission CRnear CRvery good partial remission VGPR rate and event-free and overall survival
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