Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081939
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2004-04-27
Brief Title:
UARK 2003-33 Total Therapy III
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
A Phase 2 Study Incorporating Bone Marrow Microenvironment ME Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DT PACE for InductionConsolidation and Thalidomide Dexamethasone for Maintenance
Status:
COMPLETED
Status Verified Date:
2017-09
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:
There have been two previous Total Therapy studies for multiple myeloma MM at the Myeloma Institute for Research and Therapy MIRT Total Therapy I from 1989 through 1994 and Total Therapy II from 1996 to 2004 Results have shown that patients treated on these studies had better outcomes meaning patients have lived longer and had better responses to treatment when compared to patients treated with standard chemotherapy
With this new study Total Therapy III researchers will take what they have learned from the first two studies and add new treatment strategies to try to improve the outcomes even more especially for patients with chromosome abnormalities
With this new study Total Therapy III researchers will take what they have learned from the first two studies and add new treatment strategies to try to improve the outcomes even more especially for patients with chromosome abnormalities
Detailed Description:
11 To determine in a historical comparison with TT II Thalidomide arm whether two cycles of VDTPACE induction instead of four induction cycles in TT II followed by more timely MEL 200-based transplant with DEX THAL between transplants can
111 Increase the CR frequency from 50 to 60 at 18 months from initiation of therapy
112 Increase n-CR rate pre-transplant 1 from 20 to 40
113 Raise 2-year EFS rates from 55 to 75 in patients with CA and from 80 to 95 in patients without CA
111 Increase the CR frequency from 50 to 60 at 18 months from initiation of therapy
112 Increase n-CR rate pre-transplant 1 from 20 to 40
113 Raise 2-year EFS rates from 55 to 75 in patients with CA and from 80 to 95 in patients without CA
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