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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02193698 |
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Date of registration:
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16/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial
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Scientific title:
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Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02193698 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Sonoko Misawa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chiba University, Department of Neurology |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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POEMS Syndrome
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Intervention(s)
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Drug: Lenalidomide+Dexamethasone
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Primary Outcome(s)
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Reduction rate of serum VEGF
[Time Frame: after 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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