BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients (NCT03401372) | Clinical Trial Compass
CompletedNot Applicable
BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients
China140 participantsStarted 2018-04-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years old adults.
* Biopsy proved treatment-naïve pAL amyloidosis.
* Mayo 2004 stage II-III.
* dFLC \> 50mg/L.
* Patient must provide informed consent.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.