Daratumumab for Patients With Light Chain Amyloidosis
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
Nanjing University School of Medicine
100 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.
Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.
The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06376214