NCT06376214Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Mar 2024
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Nanjing University School of Medicine
- Diseases
- Amyloidosis
- NCT number
- NCT06376214
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute or chronic infection requiring treatment within 30 days prior to baseline;
Other illness
- 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.
Lab values
- eGFR\< 30ml/min/1.73m2;
Other
- Combined multiple myeloma;
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Clinical Research Center for Kidney Diseases, Jinling Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.