Clinical Trial: The Treatment of Lenalidomide in Patients With POEMS Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
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 Summary:
Sponsor: Istituto Clinico Humanitas
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Evaluation of the safety and the activity. [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Istituto Clinico Humanitas
Dates:
Date Received: September 3, 2009
Date Started: July 2009
Date Completion: July 2011
Last Updated: September 1, 2010
Last Verified: September 2010
