NCT00971685

The Treatment of Lenalidomide in Patients With POEMS Syndrome

Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• POEMS Syndrome

Interventions

Type	Name	Description
DRUG	Lenalidomide and dexamethasone	RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-12-01
• Completion: 2011-07-01
• First posted: 2009-09-04
• Last updated: 2010-09-02

Locations

1 site across 1 country: Italy