The Treatment of Lenalidomide in Patients With POEMS Syndrome

Istituto Clinico Humanitas

Status and phase: Unknown; Phase 2

Conditions: POEMS Syndrome

Treatments: Drug: Lenalidomide and dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00971685

ONC-2008-002

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Lenalidomide plus Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide and dexamethasone