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

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center 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

Genetics Home Reference related topics: aceruloplasminemia

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

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

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 2010
Estimated Primary Completion Date:	April 2010 (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.

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

Contacts

Contact: Tracy L. Ostler, BS, CCRP

603-650-4145

Tracy.L.Ostler@Hitchcock.org

Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Tracy L. Ostler, BS 603-650-4145 Tracy.L.Ostler@Hitchcock.org
Principal Investigator: Elijah W. Stommel, MD, PhD

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Celgene Corporation

Investigators

Principal Investigator:

Elijah W. Stommel, MD, PhD

Dartmouth-Hitchcock Medical Center

More Information

Responsible Party:	Dartmouth-Hitchcock Medical Center ( Elijah Stommel, MD, PhD )
Study ID Numbers:	RV-PN-PI-235
Study First Received:	April 22, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00665652
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

Neuropathy
Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)

Study placed in the following topic categories:

Immunoproliferative Disorders
Hematologic Diseases
Blood Protein Disorders
Lenalidomide

Monoclonal Gammopathies, Benign
Paraproteinemias
Monoclonal gammopathy of undetermined significance

Additional relevant MeSH terms:

Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Hypergammaglobulinemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009