RecruitingPhase 2NCT06629818

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


Sponsor

Peking Union Medical College Hospital

Enrollment

36 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous), a drug called Dexamethasone, and others for people with light chain (al) amyloidosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDaratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)

qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12

DRUGVenetoclax

400mg po qd for 1 year

DRUGDexamethasone

Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06629818


Related Trials