drugset / Trial / NCT00588822

Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance

NCT00588822 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study was done to find out if the investigational medication, rituximab, could help relieve the symptoms of peripheral neuropathy (such as numbness \[abnormal protein in the blood\] and weakness of the lower and upper extremities) in people who have monoclonal gammopathy of undetermined significance and people with a symptomatic or smoldering Waldestrom macroglobulinemia. Rituximab is an antibody which attacks a particular type of white blood cell (B Cell). By targeting the B-cells which make the abnormal protein which is involved in causing the nerve trouble, it is hoped that damage to nerve fibers will be stopped and improvement will be allowed to proceed.

Timeline

Start
2005-01
Primary completion
2009-01
Completion
2011-02

Outcome

Outcome not reported

Stopped (Enrollment): “Discontinuation due to the high response rate at the 1st stage and slow accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous