Status:
TERMINATED
Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Neuropathy
Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Monocl...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00665652
Start Date
April 1 2008
End Date
May 19 2011
Last Update
September 11 2018
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756