Trials / Completed
CompletedNCT03401372
BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients
Comparison of Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy With or Without Doxycycline in Newly Diagnosed Mayo Stage II-III Light Chain Amyloidosis Patients: A Multi-center Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Jian Li · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxycycline | Oral doxycycline 100mg twice daily |
| DRUG | Bortezomib | 1.3mg/m2 of bortezomib on days 1, 8, 15 and 22 of a 35-day cycle |
| DRUG | Cyclophosphamide | 300mg/m2 cyclophosphamide on days 1, 8, 15 and 22 of a 35-day cycle |
| DRUG | Dexamethasone | 40mg of dexamethasone on days 1, 8, 15 and 22 of a 35-day cycle |
Timeline
- Start date
- 2018-04-21
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2018-01-17
- Last updated
- 2021-02-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03401372. Inclusion in this directory is not an endorsement.