The Treatment of Lenalidomide in Patients With POEMS Syndrome

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Unknown status

CT.gov ID

NCT00971685

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
POEMS Syndrome	Drug: Lenalidomide and dexamethasone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lenalidomide plus Dexamethasone RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).	Drug: Lenalidomide and dexamethasone RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).

Arm

Intervention/Treatment

Experimental: Lenalidomide plus Dexamethasone

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

Drug: Lenalidomide and dexamethasone

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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Evaluation of the safety and the activity. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinco Humanitas	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Principal Investigator: Armando Santoro, MD, Istituto Clinico Humanitas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00971685

Other Study ID Numbers:

ONC-2008-002

First Posted:

Sep 4, 2009

Last Update Posted:

Sep 2, 2010

Last Verified:

Sep 1, 2010

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2010