Clinical Trial: Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Dexamethasone (LDex) in Patients With Newly Diagnosed POEMS Syndrome

Brief Summary: The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.

Detailed Summary:

The investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment.

The primary endpoint would be hematological response rate according to international myeloma working group (IMWG) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (ONLS) score.

This study expects to enroll approximately 41 subjects.


Sponsor: Peking Union Medical College Hospital

Current Primary Outcome:

  • Hematological response rate [ Time Frame: last day of the LDx treatment regimen (up to 9 months) ]
  • Neurological response rate defined by ONLS score [ Time Frame: last day of the LDx treatment regimen (up to 9 months) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • response rate of critical organs [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]
  • Response rate of serum vascular endothelial growth factor (VEGF) level [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]
  • Time to initial neurological response [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]
  • Overall survival [ Time Frame: From date of first diagnosis until the date of death from any cause, otherwise patients will be censored in June, 2018 (up to 5 years) ]
  • Relapse free survival [ Time Frame: From date of first diagnosis until the date of first documented relapse or date of death from any cause, whichever came first, otherwise patients will be censored in June, 2018 (up to 5 years) ]
  • adverse events [ Time Frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug ]
  • time to the best neurological response [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]


Original Secondary Outcome:

  • response rate of critical organs [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]
  • Response rate of serum vascular endothelial growth factor (VEGF) level [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]
  • Time to initial neurological response and time to the best neurological response [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ]
  • Overall survival [ Time Frame: From date of first diagnosis until the date of death from any cause, otherwise patients will be censored in June, 2018 (up to 5 years) ]
  • Relapse free survival [ Time Frame: From date of first diagnosis until the date of first documented relapse or date of death from any cause, whichever came first, otherwise patients will be censored in June, 2018 (up to 5 years) ]
  • adverse events [ Time Frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug ]


Information By: Peking Union Medical College Hospital

Dates:
Date Received: March 14, 2013
Date Started: March 2014
Date Completion:
Last Updated: April 23, 2017
Last Verified: April 2017