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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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19 February 2015 |
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Main ID: |
NCT00971685 |
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Date of registration:
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03/09/2009 |
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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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The Treatment of Lenalidomide in Patients With POEMS Syndrome
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Scientific title:
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Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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16 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00971685 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, 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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Italy
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Contacts
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Name:
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Armando Santoro, 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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Istituto Clinico Humanitas |
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Name:
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Armando Santoro, MD |
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Address:
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Telephone:
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+39028224 |
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Email:
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armando.santoro@humanitas.it |
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Affiliation:
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Name:
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Andrea Nozza, MD |
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Address:
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Telephone:
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+39028224 |
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Email:
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andrea.nozza@humanitas.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form
Age minimum:
18 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 and dexamethasone
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Primary Outcome(s)
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Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles.
[Time Frame: one year]
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Secondary Outcome(s)
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Evaluation of the safety and the activity.
[Time Frame: one year]
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Secondary ID(s)
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ONC-2008-002
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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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