drugset / Trial / NCT06376214

Daratumumab for Patients With Light Chain Amyloidosis

NCT06376214

Recruiting 100 enrolled Nanjing University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.

Timeline

Start
2023-01-01
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg
Subject Pomalidomide Other / unclassified 4 mg Oral

Indications