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Completed

NCT Number: NCT02485613

Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male patients aged between 18 to 80 years
  • Renal or other type biopsy was used to diagnose AL amyloidosis
  • Understand and voluntarily sign an informed consent form
  • ECOG score 0-3 points
  • Adequate residual organ function

Exclusion criteria

  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Grade 3 sensory or grade 1 painful peripheral neuropathy
  • Known hypersensitivity to bortezomib, boron or mannitol
  • Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
  • Clinically overt multiple myeloma
  • Pregnant or nursing women.

Treatment and study plan

bortezominb and dexamethasone

Drug

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 dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.

Other names: Velcade

Primary outcomes

  1. Hematologic response rate

    Time frame: 3 months

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

Secondary outcomes

  1. organ response rate

    Time frame: 12 months

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

  2. Overall survival

    Time frame: From date of the start of treatment to date of death,up to 3 months

  3. Progression free survival

    Time frame: From date of the start of treatment to date of disease progression,up to 3 months

Sponsors and collaborators

Lead sponsor

Zhi-Hong Liu, M.D.

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Jun 30, 2015
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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