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
Nanjing University School of Medicine
100 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria6
- 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.
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Interventions
Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.
Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.
The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06376214