Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

June 25, 2015 updated by: Zhi-Hong Liu, M.D.

Bortezomib With Dexamethasone as the First-line Treatment 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

72

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bortezominb and dexamethasone group
Drug: bortezominb and dexamethasone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematologic response rate
Time Frame: 3 months
Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhi-Hong Liu, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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