Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485613
• Other study ID #: NJCT-1501
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: June 25, 2015
• Start date: January 2009
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Amyloidosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic response rate	Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis	3 months	No
Secondary	organ response rate	organ responses were evaluated according to the novel criteria of the International Society of Amyloidosis	12 months	No
Secondary	Overall survival		From date of the start of treatment to date of death,up to 3 months	No
Secondary	Progression free survival		From date of the start of treatment to date of disease progression,up to 3 months	No