drugset
drugset / Trial / NCT00113919

UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

NCT00113919 ↗

Phase 1/2 Terminated 14 enrolled University of Arkansas
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.

Timeline

Start
2004-06
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Busulfan Small molecule 4.3 mg/kg Intravenous
Subject Busulfan Small molecule 5.6 mg/kg Intravenous
Subject Busulfan Small molecule 6.4 mg/kg Intravenous
Background Cisplatin Other / unclassified 10 unknown Intravenous
Background Cyclophosphamide Other / unclassified 400 unknown Intravenous
Background Dexamethasone Small molecule 40 mg Oral
Background Doxorubicin Other / unclassified 10 mg/m2 Intravenous
Background Etoposide Small molecule 40 mg/m2 Intravenous
Background Thalidomide Other / unclassified 200 mg Oral

Indications

plasma cell myeloma