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

Primary Purpose

POEMS Syndrome

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Lenalidomide+Dexamethasone
Sponsored by
Chiba University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for POEMS Syndrome focused on measuring POEMS syndrome, lenalidomide

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chiba University Graduate School of Medicine Department of neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide+Dexamethasone

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction rate of serum VEGF

Secondary Outcome Measures

Full Information

First Posted
July 16, 2014
Last Updated
July 27, 2016
Sponsor
Chiba University
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1. Study Identification

Unique Protocol Identification Number
NCT02193698
Brief Title
Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POEMS Syndrome
Keywords
POEMS syndrome, lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide+Dexamethasone
Arm Type
Experimental
Arm Description
Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide+Dexamethasone
Other Intervention Name(s)
Lebramide+Decadoron
Intervention Description
Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
Primary Outcome Measure Information:
Title
Reduction rate of serum VEGF
Time Frame
after 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonoko Misawa, MD
Organizational Affiliation
Chiba University, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiba University Graduate School of Medicine Department of neurology
City
Chiba
ZIP/Postal Code
260-8760
Country
Japan

12. IPD Sharing Statement

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

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