This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.
Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;
ECOG PS score 0-2 points;
Measurable disease: The difference between affected and unaffected FLC is>20 mg/L, and the serum immunoglobulin kappa λ FLC ratio is abnormal;
Blood routine: Absolute neutrophil count ≥ 1.0 x 10 ^ 9/L, platelet count ≥ 50 x 10 ^ 9/L;
Non AL amyloidosis;
Known to be allergic, hypersensitive or intolerant to monoclonal antibodies or human derived proteins, daretozumab or its excipients, or known to be allergic to mammalian derivatives;
Female patients who have tested positive for lactation or serum pregnancy test during the screening period;
Received ASCT or had graft-versus-host disease in the past 12 months;
Yongyong MA
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Sponsor institution