Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhi-Hong Liu, M.D.
• Treatments: Antibodies; BB 1101; Bence Jones Protein; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Immunoglobulin Light Chains; Immunoglobulins

Criteria

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.