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Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance (MGUS)

Primary Purpose

Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathy focused on measuring Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS), MGUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide

Arm Description

Outcomes

Primary Outcome Measures

Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.
Minimum value of the Total Neuropathy Score is "0", maximum value is "40". A higher score represents a worsening.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2008
Last Updated
September 7, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00665652
Brief Title
Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance
Acronym
MGUS
Official Title
A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
The study has been suspended for slower than anticipated enrollment to date.
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 19, 2011 (Actual)
Study Completion Date
May 19, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
Keywords
Neuropathy, Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS), MGUS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.
Description
Minimum value of the Total Neuropathy Score is "0", maximum value is "40". A higher score represents a worsening.
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elijah W. Stommel, MD, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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

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