NCT00083460

Study of Combination PS-341 and Thalidomide in Multiple Myeloma

UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.

Detailed description

Patients will be enrolled in groups of 6-10 patients, each receiving a low dose of PS-341 (1.0 mg/m2) and different dose levels of thalidomide (50, 100, 150, and 200 mg). The first six patients in each group will receive PS-341 alone for the first cycle, and thalidomide will be added on day 22. If the combination is found to be safe in these first 6 patients, the remaining patients in each group will be enrolled. Initially, these patients will receive PS-341 alone and thalidomide will be added subsequently, if deemed safe based on the first 6 patients in each thalidomide dose cohort.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	PS-341	Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
DRUG	Thalidomide	In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
DRUG	Dexamethasone	A dose of 20mg for cylces 3-8.

Timeline

• Start date: 2001-12-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2004-05-26
• Last updated: 2010-08-02

Locations

1 site across 1 country: United States