The Treatment of Lenalidomide in Patients With POEMS Syndrome
- Registration Number
- NCT00971685
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.
More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide plus Dexamethasone Lenalidomide and dexamethasone RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
- Primary Outcome Measures
Name Time Method 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. one year
- Secondary Outcome Measures
Name Time Method Evaluation of the safety and the activity. one year
Trial Locations
- Locations (1)
Istituto Clinco Humanitas
🇮🇹Rozzano, Milano, Italy