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Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)

NCT06629818 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-06-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2026-10-14
Completion
2026-10-14

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629818 on ClinicalTrials.gov