BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients
Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
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, cyclophosphamide and dexamethasone (BCD) still failed to overcome the poor
prognosis in very advanced pAL amyloidosis patients. Recently, doxycycline was demonstrated
to induce disruption of fibril formation and reduce the number of intact fibrils in
transgenic mouse model of pAL amyloidosis. Furthermore, case-control study suggested that
adjuvant oral doxycycline could improve response and survival in cardiac pAL amyloidosis,
which necessities further confirmation through a randomized trial. Therefore, we designed a
multi-center randomized open-label controlled study to investigate the efficacy and safety of
co-administration of oral doxycycline with BCD regimen in treatment-naïve patients with Mayo
stage II-III pAL amyloidosis. The primary outcome progression-free survival, and secondary
endpoints including overall survival, hematologic response, organ response and toxicity of
doxycycline will be evaluated.
Phase:
N/A
Details
Lead Sponsor:
Jian Li
Collaborators:
Beijing Anzhen Hospital Beijing Chao Yang Hospital Chinese PLA General Hospital Nanfang Hospital of Southern Medical University Peking University First Hospital Shanghai Changzheng Hospital Tongji Hospital Union Hospital Affiliated with Tongji Medical College of HUST West China Hospital Affiliated with Sichuan University