Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
POEMS Syndrome
Both
POEMS Syndrome
Trial Information
Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Armando Santoro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istituto Clinico Humanitas
Authority:
Italy: Ministry of Health
Study ID:
ONC-2008-002
NCT ID:
NCT00971685
Start Date:
July 2009
Completion Date:
July 2011
Related Keywords:
- POEMS Syndrome
- POEMS Syndrome
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