A Phase 1 interventional study of PS-341 and Thalidomide in Multiple Myeloma, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-02.
Sponsored by University of Arkansas · Phase 1, Interventional, and Treatment
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 86 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PS-341 · Drug: Thalidomide · Drug: Dexamethasone
Drug: PS-341 · Drug: Thalidomide · Drug: Dexamethasone
Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
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.
A dose of 20mg for cylces 3-8.
Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma
Time frame: until pt progresses or unexceptible toxicity
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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University of Arkansas