The Treatment of Lenalidomide in Patients With POEMS Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was  Recruiting
Information provided by:
Istituto Clinico Humanitas Identifier:
First received: September 3, 2009
Last updated: September 1, 2010
Last verified: September 2010

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 Intervention Phase
POEMS Syndrome
Drug: Lenalidomide and dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome

Resource links provided by NLM:

Further study details as provided by Istituto Clinico Humanitas:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the safety and the activity. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00971685

Contact: Armando Santoro, MD +39028224 ext 4080
Contact: Andrea Nozza, MD +39028224 ext 4080

Istituto Clinco Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Andrea Nozza, MD    +39028224 ext 4080   
Sub-Investigator: Andrea Nozza, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas Identifier: NCT00971685     History of Changes
Other Study ID Numbers: ONC-2008-002 
Study First Received: September 3, 2009
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
POEMS Syndrome
Abnormalities, Multiple
Blood Protein Disorders
Congenital Abnormalities
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents processed this record on February 09, 2016