Actively Recruiting
Daratumumab for Patients With Light Chain Amyloidosis
Led by Nanjing University School of Medicine · Updated on 2024-04-19
100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Daratumumab for Patients With Light Chain Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years
- Newly diagnosed AL amyloidosis confirmed by pathology with at least one major organ involved (heart, kidney, or liver)
- For groups A and B, disease stage I to IIIA according to Mayo 2004 staging system
- For group C, stage IIIB disease with NT-proBNP >8500 ng/L and cTnT >0.035 bcg/L or cTnI >0.01 g/L
- Signed informed consent approved by Ethics Committee
- Expected survival of at least 12 weeks
- ECOG performance status of 2 or less
- Female participants of childbearing potential agree to use effective contraception from consent until 365 days after infusion
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
- Diagnosis of combined multiple myeloma
- Acute or chronic infection requiring treatment within 30 days before baseline
- Pregnant or breastfeeding women
- Known life-threatening allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies or immune modulators
- Other conditions judged by researchers as unsuitable for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Clinical Research Center for Kidney Diseases, Jinling Hospital
Nanjing, Jiangsu, China, 210016
Actively Recruiting
Research Team
X
Xianghua Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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