Daratumumab for Patients With Light Chain Amyloidosis (NCT06376214) | Clinical Trial Compass
RecruitingNot Applicable
Daratumumab for Patients With Light Chain Amyloidosis
China100 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants must be aged ≥18 and ≤75 years;
✓. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
✓. In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP\>8500ng/L and cTnT\>0.035μg/L or cTnI\>0.01g/L;
✓. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
✓. Expected survival ≥ 12 weeks;
✓. ECOG performance status≤ 2;
✓. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \<1% per year.