Trial record 2 of 3 for:    "POEMS syndrome"

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
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00971685
First received: September 3, 2009
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971685

Contacts
Contact: Armando Santoro, MD +39028224 ext 4080 armando.santoro@humanitas.it
Contact: Andrea Nozza, MD +39028224 ext 4080 andrea.nozza@humanitas.it

Locations
Italy
Istituto Clinco Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Andrea Nozza, MD    +39028224 ext 4080    andrea.nozza@humanitas.it   
Sub-Investigator: Andrea Nozza, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov 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
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 16, 2014