Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
Venetoclax
400mg po qd for 1 year
Dexamethasone
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months