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

NCT00665652 | Terminated Phase 2 Results DMC

• 1 other identifier: RV-PN-PI-235 D0713
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuropathy; Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)

Keywords

Neuropathy; Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS); MGUS

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12 months

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

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

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Elijah Stommel
• Organization: Dartmouth Hitchcock Medical Center

elijah.w.stommel@hitchcock.org

603-650-5104

Study Officials

• Elijah W. Stommel, MD, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: April 1, 2008
• Primary Completion: May 19, 2011
• Study Completion: May 19, 2011
• Last Updated: September 11, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-08

Locations

US (1)