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The Treatment of Lenalidomide in Patients With POEMS Syndrome

NCT00971685 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2010-09-02

No results posted yet for this study

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

DRUG

Lenalidomide and dexamethasone

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

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Armando Santoro, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2011-07-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00971685 on ClinicalTrials.gov