Status:
COMPLETED
BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients
Lead Sponsor:
Jian Li
Collaborating Sponsors:
Peking University First Hospital
Beijing Anzhen Hospital
Conditions:
Amyloidosis; Systemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Survival of intermediate and high-risk primary light chain amyloidosis (pAL) remains poor due to high mortality within 3-6 months of diagnosis. Rapidly effective regimens such as bortezomib, cyclophos...
Eligibility Criteria
Inclusion
- ≥18 years old adults.
- Biopsy proved treatment-naïve pAL amyloidosis.
- Mayo 2004 stage II-III.
- dFLC \> 50mg/L.
- Patient must provide informed consent.
Exclusion
- Co-morbidity of uncontrolled infection.
- Co-morbidity of grade 2 or 3 atrioventricular block.
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia.
- Co-morbidity of other active malignancy.
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia.
- Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
- Allergic history of doxycycline.
- Neutrophil \<1×10E9/L，hemoglobin \< 7g/dL，or platelet \< 75×10E9/L.
- Severely compromised hepatic or renal function: ALT or AST \> 2.5 × ULN, total bilirubin \> 1.5mg/dL，or eGFR \< 60mL/min.
Key Trial Info
Start Date :
April 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03401372
Start Date
April 21 2018
End Date
December 31 2020
Last Update
February 23 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730