NCT06629818

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Light Chain (AL) Amyloidosis

Interventions

Type	Name	Description
DRUG	Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)	qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
DRUG	Venetoclax	400mg po qd for 1 year
DRUG	Dexamethasone	Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-10-14
• Completion: 2026-10-14
• First posted: 2024-10-08
• Last updated: 2025-06-03

Locations

1 site across 1 country: China