Actively Recruiting
Rapid dFLC Response Predict CHR in AL Amyloidosis
Led by Peking University People's Hospital · Updated on 2026-03-09
50
Participants Needed
8
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.
CONDITIONS
Official Title
Rapid dFLC Response Predict CHR in AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic AL amyloidosis
- Treatment includes daratumumab, bortezomib, and dexamethasone
- Patient has given informed consent after explanation
- Difference in free light chains (dFLC) is 50 mg/L or higher
You will not qualify if you...
- Active multiple myeloma or active lymphoplasmacytic lymphoma
- Advanced malignant tumors with systemic metastasis
- Severe or persistent uncontrolled infections
- Severe autoimmune or immunodeficiency diseases
- Active hepatitis B or C infection, HIV infection, or syphilis infection
- Any condition increasing risk or affecting study results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Fuxing Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
3
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 101118
Actively Recruiting
4
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
5
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
6
Chinese PLA Eastern Theater General Hospital
Nanjing, Jiangsu, China
Actively Recruiting
7
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
8
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China
Actively Recruiting
Research Team
Y
Yang Liu, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here