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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00971685
Study type Interventional
Source Istituto Clinico Humanitas
Contact Armando Santoro, MD
Phone +39028224
Email armando.santoro@humanitas.it
Status Recruiting
Phase Phase 2
Start date July 2009
Completion date July 2011

See also
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Completed NCT04396496 - Treatment of POEMS Syndrome With Daratumumab Phase 2
Recruiting NCT05263817 - A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis Early Phase 1
Active, not recruiting NCT02921893 - Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome Early Phase 1
Completed NCT01816620 - Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome Phase 2
Completed NCT02193698 - Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial Phase 2
Completed NCT01639898 - POEMS Syndrome Treatment With Lenalidomide Phase 2
Recruiting NCT05476458 - To Evaluate Efficacy of Red Dichromatic Imaging (RDI) in Achieving Hemostasis During POEM Using GF 1500 UGI Scope