About this trial
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.
Eligibility criteria
Qualifiers
Biopsy proved treatment-naïve AL amyloidosis
Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
dFLC > 50mg/L
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
- Venetoclax
- Dexamethasone