Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance
Condition: Neuropathy; Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
MeSH terms: Peripheral Nervous System Diseases; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
Intervention: Lenalidomide
Intervention description: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuropathy; Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS); MGUS

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically proven MGUS associated neuropathy with a Total Neuropathy Score (TNS) ≥5
             (determined by exam, history and confirmatory EDX testing in association with MGUS
             (IgM,IgG,IgA))

          -  Disease duration less than or equal to 8 years

          -  Able to take Plavix 75mg/day or aspirin 325 mg daily as prophylactic anticoagulation.
             (patients currently taking warfarin with a stable INR may stay on current dose)

        Exclusion Criteria:

          -  Patients previously treated with thalidomide

          -  Patients previously treated with lenalidomide

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs

          -  Known positive for HIV or infectious hepatitis, type A, B or C

          -  Medical history of deep venous thrombosis or hyper-coagulable state

          -  Gastrointestinal abnormalities including: inability to take oral medication,
             requirement for intravenous alimentation, prior surgical procedures affecting
             absorption, or active peptic ulcer disease

          -  Patients with dementia, other serious neurological diseases, uncompensated medical
             illness, substance abuse and debilitating psychiatric illness.

          -  A serious uncontrolled medical disorder or active infection that would impair the
             patient's ability to receive study treatment. Significant cardiac disease, including
             uncontrolled high blood pressure, unstable angina, congestive heart failure,
             myocardial infarction within the previous 6 months or serious cardiac arrhythmias will
             be excluded.

          -  Medical conditions associated with neuropathy such as active thyroid disease, diabetes
             mellitus, and lupus, nutritional deficiencies, malignancy, human immunodeficiency
             virus infection, alcohol dependence, amyloidosis, or connective tissue diseases and
             Guillain-Barre Syndrome. Medications or toxic exposures known to cause neuropathy, or
             a family history of neuropathy will also be grounds for exclusion.

          -  Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide).

          -  Subjects who are allergic to aspirin or Plavix (clopidogrel)