Status:
COMPLETED
Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial
Lead Sponsor:
Chiba University
Conditions:
POEMS Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
Detailed Description
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.
Eligibility Criteria
Inclusion
- Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
- Recurrent or refractory Crow-Fukase syndrome.
- Patients without severe liver or renal dysfunction.
- Patients without severe neutropenia or thrombocytopenia.
- Patients without clinically problematic ECG findings
- Negative on the pregnacy test on the day 1 of cycle 1.
- Patients who can undertake prevention of pregnancy, if necessary.
- Patients with written informed consent.
- Patients who are capable of ambulatory hospital visits every 4 weeks.
- Patients with informed consent to the registration and rules of RevMate®.
Exclusion
- Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
- Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
- Patients who have been administered bevacizumab within 12 weeks prior to the registration.
- Patients who could worsen acutely during the clinical trial period.
- Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
- Patients with malignancies.
- Female patients who are pregnant or desire childbearing. Males who desire fertility.
- Patients who allergic to lenalidomide or dexamethasone.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02193698
Start Date
July 1 2014
End Date
April 1 2016
Last Update
July 29 2016
Active Locations (1)
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1
Chiba University Graduate School of Medicine Department of neurology
Chiba, Chiba, Japan, 260-8760