Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial

This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.

Inclusion criteria

• 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 criteria

• 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.