Clinical Trial: Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Bortezomib With Dexamethasone as the First-line Treatment for Immunoglobulin Light Chain(AL) Amyloidosis

Brief Summary: Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Detailed Summary: This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.
Sponsor: Zhi-Hong Liu, M.D.

Current Primary Outcome: Hematologic response rate [ Time Frame: 3 months ]

Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • organ response rate [ Time Frame: 12 months ]
    organ responses were evaluated according to the novel criteria of the International Society of Amyloidosis
  • Overall survival [ Time Frame: From date of the start of treatment to date of death,up to 3 months ]
  • Progression free survival [ Time Frame: From date of the start of treatment to date of disease progression,up to 3 months ]


Original Secondary Outcome: Same as current

Information By: Nanjing University School of Medicine

Dates:
Date Received: June 24, 2015
Date Started: January 2009
Date Completion:
Last Updated: June 25, 2015
Last Verified: June 2015