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Daratumumab for Patients With Light Chain Amyloidosis

RecruitingNAAges 18 Years - 75 YearsAllNanjing University School of Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Participants must be aged ≥18 and ≤75 years; 2. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver)); 3. 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; 4. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study; 5. Expected survival ≥ 12 weeks; 6. ECOG performance status≤ 2; 7. 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. Exclusion Criteria: 1. eGFR\< 30ml/min/1.73m2; 2. Combined multiple myeloma; 3. Acute or chronic infection requiring treatment within 30 days prior to baseline; 4. Pregnant or breastfeeding women. 5. Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators. 6. Other conditions deemed by the researcher as unsuitable for enrollment.
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What it tests

  • Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
  • Pomalidomide 4 MG
  • autologous stem cell transplantation (ASCT)
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Where

1 site
National Clinical Research Center for Kidney Diseases, Jinling Hospital
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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