Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

Zhi-Hong Liu, M.D.

Status: Completed

Conditions: Amyloidosis

Treatments: Drug: bortezominb and dexamethasone

Study type: Observational

Funder types: Other

Identifiers

NCT02485613

NJCT-1501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

72 participants in 1 patient group

bortezominb and dexamethasone group

Treatment:

Drug: bortezominb and dexamethasone