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Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

NCT ID: NCT02485613

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-03-31

Brief Summary

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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 Description

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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.

Conditions

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Amyloidosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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bortezominb and dexamethasone group

bortezominb and dexamethasone

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Velcade

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhi-Hong Liu, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Zhi-Hong Liu, M.D.

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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NJCT-1501

Identifier Type: -

Identifier Source: org_study_id