Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance — MGUS  

Neuropathy Clinical Trial

Official title: A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)

Status Terminated

Clinical Trial Summary

The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).

Clinical Trial Description

Screening:

All subjects eligible for screening must sign an informed consent for the study prior to any study related procedures.

Study Design:

This is an open-label, single-institutional clinical study of lenalidomide as a treatment for MGUS associated neuropathy. Eligible patients will be followed for 28 days before starting study drug. Subjects who remain eligible during the 28 day pretreatment period will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles. All patients on treatment will be followed and will be included in the intention to treat group. Patients will be evaluated every three months with the TNS. On-treatment patients must come to clinic at least monthly for the first 3 cycles, and then can come as per the schedule of study assessments only if they are on a stable dose of lenalidomide for at least one cycle. Subjects will be enrolled in the study for up to 14 months.

Lenalidomide administration:

Lenalidomide is an oral medication that will be taken at approximately the same time each day with or without food.

Lenalidomide capsules should be swallowed whole, and should not be broken, chewed or opened.

If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up.

Patients who take more than the prescribed dose of lenalidomide should be instructed to seek emergency medical care if needed and contact study staff immediately.

Dosing Regimen:

The planned dose of lenalidomide for investigation is 25 mg/day, orally on days 1-21 followed by 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day. The planned dose is: Plavix 75mg/day or aspirin 325mg/day.

Subjects experiencing adverse events may need study treatment modifications ;

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Neuropathy
• Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Paraproteinemias
• Peripheral Nervous System Diseases

• NCT number: NCT00665652
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Terminated
• Phase: Phase 2
• Start date: April 2008
• Completion date: May 19, 2011