Daratumumab for Patients With Light Chain Amyloidosis
Recruiting now · Not applicable
Conditions studied: Light Chain (AL) Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT06376214
- Run by
- Nanjing University School of Medicine
- People needed
- 100
- Starts
- 2023-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-04-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- eGFR< 30ml/min/1.73m2;
- Combined multiple myeloma;
- Acute or chronic infection requiring treatment within 30 days prior to baseline;
- Pregnant or breastfeeding women.
- Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
- Other conditions deemed by the researcher as unsuitable for enrollment.
Where it is running
- National Clinical Research Center for Kidney Diseases, Jinling Hospital — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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