2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE
|ClinicalTrials.gov Identifier: NCT00577512|
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : May 13, 2011
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: DTPACE||Phase 2|
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 the University of Arkansas for Medical Sciences (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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||2006-32: Phase II Study of Rapidly Recycled High Dose DTPACE (HD-DTPACE) for Untreated or Previously Treated, High-Risk Multiple Myeloma (MM)|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Experimental: HD DTPACE
- 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 ]
Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions.
Near Complete Response included all elements of CR except immunofixation studies remained positive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577512
|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|