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Study of Combination PS-341 and Thalidomide in Multiple Myeloma

NCT00083460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2010-08-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Barlogie Barthel, M.D. Ph.D · University of Arkanas for Medical Sciences website

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00083460 on ClinicalTrials.gov