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Daratumumab for Patients With Light Chain Amyloidosis
Sponsor: Nanjing University School of Medicine
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.
Official title: Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-01-01
Completion Date
2026-12-31
Last Updated
2024-04-19
Healthy Volunteers
No
Conditions
Interventions
Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.
Pomalidomide 4 MG
Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.
autologous stem cell transplantation (ASCT)
The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .
Locations (1)
National Clinical Research Center for Kidney Diseases, Jinling Hospital
Nanjing, Jiangsu, China