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

July 27, 2016 updated by: Sonoko Misawa, Chiba University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8760
        • Chiba University Graduate School of Medicine Department of neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction rate of serum VEGF
Time Frame: after 24 weeks
after 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiba University

Investigators

  • Principal Investigator: Sonoko Misawa, MD, Chiba University, Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G26007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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