Clinical Trial: Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

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

Official Title: Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

Brief Summary:

Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).

The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).

Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).


Detailed Summary: Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
Sponsor: Clinical Service, China

Current Primary Outcome: overall response rate [ Time Frame: Day 1 of every treatment cycle ]

The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the rate of response [ Time Frame: Day 1 of every treatment cycle ]
    The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
  • partial remission rate [ Time Frame: Day 1 of every treatment cycle ]
    The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
  • duration of response [ Time Frame: up to 6 months ]
  • overall survival [ Time Frame: up to two and a half year ]
  • Adverse Events [ Time Frame: up to two and a half years ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
  • FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ]


Original Secondary Outcome:

  • the rate of response [ Time Frame: Day 1 of every treatment cycle ]
    The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
  • partial remission rate [ Time Frame: Day 1 of every treatment cycle ]
    The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
  • duration of response [ Time Frame: up to 6 months ]
  • overall survival [ Time Frame: up to two and a half year ]
  • Adverse Events [ Time Frame: up to the end of the treatment (up to two and a half years) ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
  • FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ]


Information By: Clinical Service, China

Dates:
Date Received: March 29, 2011
Date Started: September 2010
Date Completion: September 2015
Last Updated: September 21, 2011
Last Verified: September 2011