NCT00113932

UARK 2003-41: A Study of High-Dose Density Therapy in Patients With Multiple Myeloma

UARK 2003-41: A Phase II Study of High-Dose Density Therapy With Tandem Autologous Transplants for Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past.

Detailed description

This study will evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	High-Dose Density Therapy	Dexamethasone 40mg po 1-4, Thalidomide 200 mg po 1-6hrs then daily after transplant; Cisplatin\* 10 mg/m2 Continuous infusion 1-4;Adriamycin 10 mg/m2 Continuous infusion 1-4;Cyclophosphamide 400 mg/m2 Continuous infusion 1-4; Etoposide 40 mg/m2 Continuous infusion 1-4; Pegfilgrastim 6 mg subcutaneously 6 and 13; Darbepoetin 200μg subcutaneously Between -6 to-1 +12, \& every 2 weeks until HB \>12 gm/dl\*\*\*; Lovenox (or other LMWH) 40 mg subcutaneously Daily until Pltcount \<30,000/μl

Timeline

• Start date: 2003-12-01
• Primary completion: 2009-02-01
• Completion: 2010-07-01
• First posted: 2005-06-13
• Last updated: 2011-09-02

Locations

1 site across 1 country: United States