NCT00577512

2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE

2006-32: Phase II Study of Rapidly Recycled High Dose DTPACE (HD-DTPACE) for Untreated or Previously Treated, High-Risk Multiple Myeloma (MM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	DTPACE	* Dexamethasone 200 mg Intravenous Infusion "Piggy-Back" (IVPB) Days 1-7 * Thalidomide 200 mg by mouth (PO) Days 1-7 * Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency) * Adriamycin 15 mg/m2 Days 1-4 * Cyclophosphamide 600 mg/m2 Days 1-4 * Etoposide 60 mg/m2 Days 1-4

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-12-20
• Last updated: 2017-11-20
• Results posted: 2011-05-13

Locations

1 site across 1 country: United States