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The Treatment of Lenalidomide in Patients With POEMS Syndrome

Primary Purpose

POEMS Syndrome

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Lenalidomide and dexamethasone

About this trial

This is an interventional treatment trial for POEMS Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Istituto Clinco HumanitasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide plus Dexamethasone

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

Evaluation of the safety and the activity.

Full Information

NCT ID

NCT00971685

First Posted

September 3, 2009

Last Updated

September 1, 2010

Sponsor

Istituto Clinico Humanitas

1. Study Identification

Unique Protocol Identification Number

NCT00971685

Brief Title

The Treatment of Lenalidomide in Patients With POEMS Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

POEMS Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide plus Dexamethasone

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lenalidomide and dexamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Evaluation of the safety and the activity.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Armando Santoro, MD

Phone

+39028224

Ext

4080

armando.santoro@humanitas.it

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Nozza, MD

Phone

+39028224

Ext

4080

andrea.nozza@humanitas.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Armando Santoro, MD

Organizational Affiliation

Istituto Clinico Humanitas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Clinco Humanitas

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Nozza, MD

Phone

+39028224

Ext

4080

andrea.nozza@humanitas.it

First Name & Middle Initial & Last Name & Degree

Andrea Nozza, MD

12. IPD Sharing Statement

Learn more about this trial

The Treatment of Lenalidomide in Patients With POEMS Syndrome

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