Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

Completed

• Conditions: Amyloidosis
• Interventions: Drug: bortezominb and dexamethasone

• Registration Number: NCT02485613
• Lead Sponsor: Zhi-Hong Liu, M.D.

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 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 Timeline

• Study Start: 2009-01
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Study First Posted: 2015-06-30
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bortezominb and dexamethasone group	bortezominb and dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Hematologic response rate	3 months	Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis

Secondary Outcome Measures

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