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

Study Overview
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Brief Summary
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This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.

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

Official Title
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Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome

Conditions
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POEMS Syndrome

Intervention / Treatment
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* Drug: Lenalidomide+Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenalidomide+Dexamethasone<br>Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23) | Drug: Lenalidomide+Dexamethasone<br>* Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)<br>* Other names: Lebramide+Decadoron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction rate of serum VEGF |  | after 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POEMS syndrome, lenalidomide