Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance - Full Text View

Sponsor:	Dartmouth-Hitchcock Medical Center
Collaborator:	Celgene Corporation
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00665652

Purpose

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).

Condition	Intervention	Phase
Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)	Drug: Lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.

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 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665652

Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Celgene Corporation

Investigators

Principal Investigator:

Elijah W. Stommel, MD, PhD

Dartmouth-Hitchcock Medical Center

More Information

No publications provided

Responsible Party:	Elijah Stommel, MD, PhD, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00665652 History of Changes
Other Study ID Numbers:	RV-PN-PI-235
Study First Received:	April 22, 2008
Last Updated:	June 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

Neuropathy
Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
MGUS

Additional relevant MeSH terms:

Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

Signs and Symptoms
Poisoning
Substance-Related Disorders
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012