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

Phase 2

Completed

• Conditions: POEMS Syndrome
• Interventions: Drug: Lenalidomide+Dexamethasone

• Registration Number: NCT02193698
• Lead Sponsor: Chiba University

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
2. Recurrent or refractory Crow-Fukase syndrome.
3. Patients without severe liver or renal dysfunction.
4. Patients without severe neutropenia or thrombocytopenia.
5. Patients without clinically problematic ECG findings
6. Negative on the pregnacy test on the day 1 of cycle 1.
7. Patients who can undertake prevention of pregnancy, if necessary.
8. Patients with written informed consent.
9. Patients who are capable of ambulatory hospital visits every 4 weeks.
10. Patients with informed consent to the registration and rules of RevMate®.

Exclusion Criteria

1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
3. Patients who have been administered bevacizumab within 12 weeks prior to the registration.
4. Patients who could worsen acutely during the clinical trial period.
5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
6. Patients with malignancies.
7. Female patients who are pregnant or desire childbearing. Males who desire fertility.
8. Patients who allergic to lenalidomide or dexamethasone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenalidomide+Dexamethasone	Lenalidomide+Dexamethasone	Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Primary Outcome Measures

Name	Time	Method
Reduction rate of serum VEGF	after 24 weeks

Trial Locations

Locations (1)

Chiba University Graduate School of Medicine Department of neurology; 🇯🇵 Chiba, Japan