<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02193698</url>
  </required_header>
  <id_info>
    <org_study_id>G26007</org_study_id>
    <nct_id>NCT02193698</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiba University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiba University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent&#xD;
      or refractory POEMS (Crow-Fukase) syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent&#xD;
      /refractory POEMS (Crow-Fukase) syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction rate of serum VEGF</measure>
    <time_frame>after 24 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>POEMS Syndrome</condition>
  <arm_group>
    <arm_group_label>Lenalidomide+Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide+Dexamethasone</intervention_name>
    <description>Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)</description>
    <arm_group_label>Lenalidomide+Dexamethasone</arm_group_label>
    <other_name>Lebramide+Decadoron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)&#xD;
&#xD;
          2. Recurrent or refractory Crow-Fukase syndrome.&#xD;
&#xD;
          3. Patients without severe liver or renal dysfunction.&#xD;
&#xD;
          4. Patients without severe neutropenia or thrombocytopenia.&#xD;
&#xD;
          5. Patients without clinically problematic ECG findings&#xD;
&#xD;
          6. Negative on the pregnacy test on the day 1 of cycle 1.&#xD;
&#xD;
          7. Patients who can undertake prevention of pregnancy, if necessary.&#xD;
&#xD;
          8. Patients with written informed consent.&#xD;
&#xD;
          9. Patients who are capable of ambulatory hospital visits every 4 weeks.&#xD;
&#xD;
         10. Patients with informed consent to the registration and rules of RevMate®.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4&#xD;
             weeks prior to the registration.&#xD;
&#xD;
          2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2&#xD;
             weeks prior to the registration.&#xD;
&#xD;
          3. Patients who have been administered bevacizumab within 12 weeks prior to the&#xD;
             registration.&#xD;
&#xD;
          4. Patients who could worsen acutely during the clinical trial period.&#xD;
&#xD;
          5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure,&#xD;
             bleeding enterogastric ulcer, ileus, poorly controlled diabetes.&#xD;
&#xD;
          6. Patients with malignancies.&#xD;
&#xD;
          7. Female patients who are pregnant or desire childbearing. Males who desire fertility.&#xD;
&#xD;
          8. Patients who allergic to lenalidomide or dexamethasone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonoko Misawa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chiba University, Department of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chiba University Graduate School of Medicine Department of neurology</name>
      <address>
        <city>Chiba</city>
        <zip>260-8760</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 27, 2016</last_update_submitted>
  <last_update_submitted_qc>July 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiba University</investigator_affiliation>
    <investigator_full_name>Sonoko Misawa</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>POEMS syndrome</keyword>
  <keyword>lenalidomide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>POEMS Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193698
org study id: G26007
nct id: NCT02193698
lead sponsor: 
has dmc: Yes
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent
      or refractory POEMS (Crow-Fukase) syndrome.
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent
      /refractory POEMS (Crow-Fukase) syndrome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction rate of serum VEGF
time frame: after 24 weeks
arm group label: Lenalidomide+Dexamethasone
arm group type: Experimental
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: Lenalidomide+Dexamethasone
description: Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
arm group label: Lenalidomide+Dexamethasone
other name: Lebramide+Decadoron
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sonoko Misawa, MD
role: Principal Investigator
affiliation: Chiba University, Department of Neurology
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Chiba University
investigator full name: Sonoko Misawa
investigator title: Associate Professor
mesh term: POEMS Syndrome
mesh term: Syndrome
mesh term: Dexamethasone
mesh term: Lenalidomide