Using daratumumab to treat patients with light chain amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of daratumumab in patients diagnosed with light chain amyloidosis. Participants are divided into three groups: one receiving long-term daratumumab treatment, another undergoing autologous stem cell transplantation after initial daratumumab treatment, and a third group consisting of newly diagnosed stage IIIb patients receiving a combination of daratumumab, dexamethasone, and pomalidomide. The treatment regimen involves intravenous daratumumab infusions followed by regular disease evaluations. The study aims to determine the best treatment approach for this condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Clinical Research Center for Kidney Diseases, Jinling Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xianghua Huang, MD — Jinling Hospital, China
• Study coordinator: Xianghua Huang, MD
• Email: hxhszb@163.com
• Phone: 02580862351

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.