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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00971685
Date of registration: 03/09/2009
Prospective Registration: Yes
Primary sponsor: Istituto Clinico Humanitas
Public title: The Treatment of Lenalidomide in Patients With POEMS Syndrome
Scientific title: Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
Date of first enrolment: July 2009
Target sample size: 16
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00971685
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Italy
Contacts
Name:     Andrea Nozza, MD
Address: 
Telephone: +39028224
Email: andrea.nozza@humanitas.it
Affiliation: 
Name:     Armando Santoro, MD
Address: 
Telephone: +39028224
Email: armando.santoro@humanitas.it
Affiliation: 
Name:     Armando Santoro, MD
Address: 
Telephone:
Email:
Affiliation:  Istituto Clinico Humanitas
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
POEMS Syndrome
Intervention(s)
Drug: Lenalidomide and dexamethasone
Primary Outcome(s)
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]
Secondary Outcome(s)
Evaluation of the safety and the activity. [Time Frame: one year]
Secondary ID(s)
ONC-2008-002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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