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The Treatment of Lenalidomide in Patients With POEMS Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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: 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 ]

Secondary Outcome Measures:
  • Evaluation of the safety and the activity. [ Time Frame: one year ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
POEMS Syndrome
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Blood Protein Disorders
Hematologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017