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Immunomodulatory Agent

Lenalidomide for Peripheral Neuropathy

Phase 1
Waitlist Available
Led By Bakri Elsheikh, MBBS
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment duration up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug called lenalidomide to see if it helps people with a rare autoimmune disorder called anti-myelin-associated glycoprotein (MAG) neuropathy. The trial will explore if lenalidomide is effective in treating this disorder by looking at quality of life, neurologic function, and other measures.

Eligible Conditions
  • Peripheral Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment duration up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment duration up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD
Secondary outcome measures
Dose Extension
Other outcome measures
EQ-5D-5L
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenalidomide escalation and expansionExperimental Treatment1 Intervention
Among the participants who will be receiving lenalidomide, the first 12 participants will be in the dose escalation phase; with the subsequent 8 participants anticipated to receive dose expansion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,795 Previous Clinical Trials
6,373,925 Total Patients Enrolled
2 Trials studying Peripheral Neuropathy
69 Patients Enrolled for Peripheral Neuropathy
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,225 Total Patients Enrolled
Ohio State UniversityLead Sponsor
828 Previous Clinical Trials
505,740 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned lenalidomide?

"The safety of lenalidomide is estimated to be a 1 due to the Phase 1 nature of this trial, indicating limited data has been collected concerning efficacy and risk."

Answered by AI

Is this research endeavor currently accepting participants?

"While this medical trial is not actively looking for participants, as indicated on clinicaltrials.gov records it was initially posted in September 2018 and modified most recently in November 2021. Despite the inactive status of this study, there are 430 other trials still recruiting patients right now."

Answered by AI

Are there any other investigations that have looked into Lenalidomide's efficacy?

"Lenalidomide's clinical trials began in 2004 at Saint Joseph Regional Medical Center-Mishawaka and thus far, there 346 completed studies. Currently, 268 live investigations are being conducted across the United States with a concentration of research occurring out of Columbus, Ohio."

Answered by AI

To what illnesses does Lenalidomide generally provide relief?

"Lenalidomide is frequently employed to treat multiple myeloma, but it has also shown some efficacy in treating chronic lymphocytic leukemia and refractory/relapsed lymphoma after two courses of systemic chemotherapy."

Answered by AI

To what extent is this study population being scrutinized?

"The clinical trial advertised is unfortunately no longer recruiting patients, having been posted on September 10th 2018 and last updated November 3rd 2021. For those seeking alternative studies, there are 162 trials examining peripheral nervous system diseases and 268 involving lenalidomide currently enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Lenalidomide in Anti-MAG Neuropathy: Phase 1b Study
Bakri Elsheikh 2018. "Lenalidomide in Anti-MAG Neuropathy: Phase 1b Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03701711.
~2 spots leftby Apr 2025
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