- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00665652
Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance (MGUS)
A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lenalidomide
|
Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.
Time Frame: Baseline, 12 months
|
Minimum value of the Total Neuropathy Score is "0", maximum value is "40".
A higher score represents a worsening.
|
Baseline, 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elijah W. Stommel, MD, PhD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Neuromuscular Diseases
- Blood Protein Disorders
- Hypergammaglobulinemia
- Peripheral Nervous System Diseases
- Paraproteinemias
- Monoclonal Gammopathy of Undetermined Significance
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- RV-PN-PI-235 D0713
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuropathy
-
Arash Asher, MDVoxxLifeRecruitingNeuropathy | Chemotherapy-induced Peripheral Neuropathy | Neuropathy;PeripheralUnited States
-
Henry Ford Health SystemOctapharma USA, Inc.RecruitingSmall Fiber Neuropathy | Autoimmune Small Fiber Neuropathy | Inflammatory Polyneuropathy | Immune-Mediated NeuropathyUnited States
-
Nihon Pharmaceutical Co., LtdCompletedMultifocal Motor NeuropathyJapan
-
University of AarhusCompletedMultifocal Motor NeuropathyDenmark
-
Beth Israel Deaconess Medical CenterPhoenix Neurological Associates, LTDCompletedSmall Fiber Neuropathy | Idiopathic Peripheral NeuropathyUnited States
-
Tanta UniversityCompletedDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Painful Diabetic Neuropathy | Autonomic Neuropathy | Diabetic Polyneuropathy | Small Fiber NeuropathyEgypt
-
Yung-Tsan WuCompleted
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
Sorlandet Hospital HFOslo University Hospital; University Hospital of North Norway; University Hospital...Not yet recruitingSmall Fiber Neuropathy | Sensory Neuropathy
-
Tri-Service General HospitalCompleted
Clinical Trials on Lenalidomide
-
Sidney Kimmel Comprehensive Cancer Center at Johns...TerminatedMyelodysplastic SyndromeUnited States
-
Grupo Español de Linfomas y Transplante Autólogo...Celgene Corporation; Dynamic Science S.L.; Thermo Fisher Scientific, IncCompleted
-
Celgene CorporationICON Clinical ResearchCompletedMyelodysplastic SyndromesGermany, Israel, United Kingdom, Spain, Belgium, Italy, France, Netherlands, Sweden
-
Boston VA Research Institute, Inc.Celgene Corporation; Edward Hines Jr. VA Hospital; Michael E. DeBakey VA Medical... and other collaboratorsCompletedMultiple MyelomaUnited States
-
Swiss Group for Clinical Cancer ResearchTerminatedLymphomaSwitzerland, Norway, Sweden
-
Dana-Farber Cancer InstituteBeth Israel Deaconess Medical Center; Genentech, Inc.; Brigham and Women's Hospital and other collaboratorsTerminatedWaldenstrom's MacroglobulinemiaUnited States
-
University Hospital, ToulouseCelgene Corporation; Janssen-Cilag Ltd.Completed
-
CelgeneCompletedRelapsed or Refractory Chronic Lymphocytic LeukemiaUnited States, Canada, United Kingdom, France, Germany, Spain, Italy, Sweden
-
Groupe Francophone des MyelodysplasiesUnknownMyelodysplastic SyndromesFrance