UARK 2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE
This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will have better outcomes.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||UARK 2006-32: Phase II Study of Rapidly Recycled High Dose DTPACE (HD-DTPACE) for Untreated or Previously Treated, High-Risk Multiple Myeloma (MM)|
- Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- In Subjects Achieving a Response, to Find Out How Long the Response Will Last. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: HD DTPACE
This study has the following goals:
- To find out how many subjects treated with high dose DTPACE (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide. (HD DTPACE) on this protocol will have a complete response or near complete response that lasts for 6 months or longer.
- In subjects achieving a response, to find out how long the response will last.
- To learn more about the side effects of this treatment.
Up to 75 subjects, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS only.
The treatment in this study is divided into 3 parts
- High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored.
- High dose DTPACE and stem cell re-infusion.
- Velcade, Thalidomide, Dexamethasone (sometimes known as VTD) Maintenance therapy.
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Frits van Rhee, MD, PhD||University of Arkansas|