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

Sponsor

Chiba University (Other)

Overall Status

Completed

CT.gov ID

NCT02193698

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
POEMS Syndrome	Drug: Lenalidomide+Dexamethasone	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Drug: Lenalidomide+Dexamethasone Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23) Other Names: Lebramide+Decadoron

Arm

Intervention/Treatment

Experimental: 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)

Drug: Lenalidomide+Dexamethasone

Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Other Names:

Lebramide+Decadoron

Outcome Measures

Primary Outcome Measures

Reduction rate of serum VEGF [after 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.