Clinical Trial: Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

Brief 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).

Detailed Summary:

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.

Sponsor: Dartmouth-Hitchcock Medical Center

Current Primary Outcome: The primary objective is to evaluate the change in neuropathy in subjects with MGUS associated neuropathy after treatment with lenalidomide. [ Time Frame: Once 15 participants have been treated with three cycles of lenalidomide. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Dartmouth-Hitchcock Medical Center

Dates:
Date Received: April 22, 2008
Date Started: April 2008
Date Completion: April 2014
Last Updated: June 22, 2011
Last Verified: June 2011