Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.
Biopsy proved treatment-naïve AL amyloidosis
Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
dFLC > 50mg/L
Co-morbidity of uncontrolled infection
Co-morbidity of other active malignancy
Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
Single group
Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
Drugqw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
Venetoclax
Drug400mg po qd for 1 year
Dexamethasone
DrugDexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation
Overall survival
Time to next treatment
CR+VGPR at 1 month after treatment initiation
CR+VGPR at 6 months after treatment initiation
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