Clinical Trial: CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary

Brief Summary: The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.

Detailed Summary:
Sponsor: Beijing Chao Yang Hospital

Current Primary Outcome: Number of patients with overall hematologic response [ Time Frame: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months) ]

Complete response, very good partial response and partial response


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with EMP response [ Time Frame: Assessed every 2 cyeles period is projected to be approximately 24 months ]
    response rate
  • Overall survival [ Time Frame: Monthly up to 3 years ]
    The median overall survival
  • Time from diagnosis ofEMP to the date of death [ Time Frame: Monthly up to 3 years ]
  • Progression free survival [ Time Frame: Monthly up to 2 years ]
  • Time from date of diagnosis of EMP to the date of first documentation of disease [ Time Frame: Monthly up to 2 years ]
  • Number of adverse events [ Time Frame: Monthly up to 3 years ]
    Adverse events, serious adverse events, assessment of clinical laboratory values from the date of signing of the informed consent form through 30 days after the last dose of study drug.


Original Secondary Outcome: Same as current

Information By: Beijing Chao Yang Hospital

Dates:
Date Received: January 8, 2015
Date Started: December 2014
Date Completion: December 2016
Last Updated: January 12, 2015
Last Verified: January 2015