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RECRUITING
NCT06376214
NA

Daratumumab for Patients With Light Chain Amyloidosis

Sponsor: Nanjing University School of Medicine

View on ClinicalTrials.gov

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

Interventions

DRUG

Dratumumab / Hyaluronidase Injection [Darzalex Faspro]

Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.

DRUG

Pomalidomide 4 MG

Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.

PROCEDURE

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