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Trial record 74 of 374 for:    LENALIDOMIDE AND Dexamethasone

The Treatment of Lenalidomide in Patients With POEMS Syndrome

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ClinicalTrials.gov Identifier: NCT00971685
Recruitment Status : Unknown
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : September 4, 2009
Last Update Posted : September 2, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Tracking Information
First Submitted Date  ICMJE September 3, 2009
First Posted Date  ICMJE September 4, 2009
Last Update Posted Date September 2, 2010
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00971685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Evaluation of the safety and the activity. [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Treatment of Lenalidomide in Patients With POEMS Syndrome
Official Title  ICMJE Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE POEMS Syndrome
Intervention  ICMJE Drug: Lenalidomide and dexamethasone
RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
Study Arms  ICMJE Experimental: Lenalidomide plus Dexamethasone
RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
Intervention: Drug: Lenalidomide and dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 3, 2009)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00971685
Other Study ID Numbers  ICMJE ONC-2008-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Armando Santoro, MD, Istituto Clinico Humanitas
Study Sponsor  ICMJE Istituto Clinico Humanitas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP