The Treatment of Lenalidomide in Patients With POEMS Syndrome

NCT00971685 | Unknown Phase 2

• 1 other identifier: ONC-2008-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

POEMS Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the safety and the activity.

  one year

Study Arms (1)

Lenalidomide plus Dexamethasone

EXPERIMENTAL

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

Drug: Lenalidomide and dexamethasone

Interventions

Lenalidomide and dexamethasone DRUG

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

Lenalidomide plus Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinco Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

POEMS Syndrome

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Santoro, MD

CONTACT

+39028224; armando.santoro@humanitas.it

Andrea Nozza, MD

CONTACT

+39028224; andrea.nozza@humanitas.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2011
• Last Updated: September 2, 2010

Record last verified: 2010-09

Locations

IT (1)