NCT06376214 Daratumumab for Patients With Light Chain Amyloidosis
| NCT ID | NCT06376214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing University School of Medicine |
| Condition | Light Chain (AL) Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Xianghua Huang, MD
PRINCIPAL INVESTIGATOR
Jinling Hospital, China
Frequently Asked Questions
Who can join the NCT06376214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Light Chain (AL) Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06376214 currently recruiting?
Yes, NCT06376214 is actively recruiting participants. Contact the research team at hxhszb@163.com for enrollment information.
Where is the NCT06376214 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06376214 clinical trial?
NCT06376214 is sponsored by Nanjing University School of Medicine. The principal investigator is Xianghua Huang, MD at Jinling Hospital, China. The trial plans to enroll 100 participants.