Spots Global Cancer Trial Database for Study of Combination PS-341 and Thalidomide in Multiple Myeloma

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Trial Identification

Brief Title: Study of Combination PS-341 and Thalidomide in Multiple Myeloma

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

Study ID: NCT00083460

Conditions

Multiple Myeloma

Interventions

PS-341

Thalidomide

Dexamethasone

Study Description

Brief 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.