Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083551
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2004-05-25
Brief Title:
UARK 98-026 TT II Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 98-026 Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-10
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:
This study has been designed to evaluate whether anti-angiogenesis therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur
Detailed Description:
Treatment will be given in 4 phases or steps Induction Transplant 1 and 2 Consolidation and maintenance Induction is designed to induce or bring about myeloma into remission Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide Some patients may be eligible to receive the transplant as an outpatient based on general health and other factorsAfter recovery from the transplant phase of the study approximately 6 weeks patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment All patients will receive post-transplant consolidation treatment which in earlier studies has been found to be helpful in maintaining patients response after transplant Therefore all patients will receive a combination of drugs called D PACE which consists of Dexamethasone Cis-Platinum Adriamycin Cyclophosphamide and Etoposide If you are also taking thalidomide you will continue taking it throughout and the treatment is called DT PACE to include the thalidomide No sooner than 4 weeks and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete you will begin the last phase of the study which is maintenance Maintenance is designed to keep your myeloma in remission long-term
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