The Treatment of Lenalidomide in Patients With POEMS Syndrome

POEMS Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00971685
• Other study ID #: ONC-2008-002
• Status: Recruiting
• Phase: Phase 2
• First received: September 3, 2009
• Last updated: September 1, 2010
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2010
• Source: Istituto Clinico Humanitas
• Contact: Armando Santoro, MD
• Phone: +39028224
• Email: armando.santoro[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: July 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• POEMS Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Clinco Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of the safety and the activity.		one year	No