Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amyloidosis; Systemic | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxycycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Doxycycline/BCD chemotherapy
- description
- Doxycycline combined with bortezomib-cyclophosphamide-dexamethasone chemotherapy
- interventionNames
- Drug: Doxycycline
- Drug: Bortezomib
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- BCD chemotherapy
- description
- Bortezomib-cyclophosphamide-dexamethasone chemotherapy
- interventionNames
- Drug: Bortezomib
- Drug: Cyclophosphamide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDWard JE, Ren R, Toraldo G, Soohoo P, Guan J, O'Hara C, Jasuja R, Trinkaus-Randall V, Liao R, Connors LH, Seldin DC. Doxycycline reduces fibril formation in a transgenic mouse model of AL amyloidosis. Blood. 2011 Dec 15;118(25):6610-7. doi: 10.1182/blood-2011-04-351643. Epub 2011 Oct 12. PMID 21998211
- RESULTShen KN, Li J. [Light Chain Amyloidosis: an Update for Treatment]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2015 Jun;23(3):910-4. doi: 10.7534/j.issn.1009-2137.2015.03.059. Chinese. PMID 26117060
- RESULTFeng J, Huang XF, Zhang CL, Shen KN, Zhang CL, Sun J, Tian Z, Cao XX, Zhang L, Zhou DB, Li J. [Analysis of clinical characteristics and outcome of patients with very high risk primary immunoglobulin light-chain amyloidosis]. Zhonghua Xue Ye Xue Za Zhi. 2017 Feb 14;38(2):107-111. doi: 10.3760/cma.j.issn.0253-2727.2017.02.005. Chinese. PMID 28279033
- RESULTDispenzieri A, Gertz MA, Kyle RA, Lacy MQ, Burritt MF, Therneau TM, Greipp PR, Witzig TE, Lust JA, Rajkumar SV, Fonseca R, Zeldenrust SR, McGregor CG, Jaffe AS. Serum cardiac troponins and N-terminal pro-brain natriuretic peptide: a staging system for primary systemic amyloidosis. J Clin Oncol. 2004 Sep 15;22(18):3751-7. doi: 10.1200/JCO.2004.03.029. PMID 15365071
- RESULTMikhael JR, Schuster SR, Jimenez-Zepeda VH, Bello N, Spong J, Reeder CB, Stewart AK, Bergsagel PL, Fonseca R. Cyclophosphamide-bortezomib-dexamethasone (CyBorD) produces rapid and complete hematologic response in patients with AL amyloidosis. Blood. 2012 May 10;119(19):4391-4. doi: 10.1182/blood-2011-11-390930. Epub 2012 Feb 13. PMID 22331188
- RESULTVenner CP, Gillmore JD, Sachchithanantham S, Mahmood S, Lane T, Foard D, Rannigan L, Gibbs SD, Pinney JH, Whelan CJ, Lachmann HJ, Hawkins PN, Wechalekar AD. A matched comparison of cyclophosphamide, bortezomib and dexamethasone (CVD) versus risk-adapted cyclophosphamide, thalidomide and dexamethasone (CTD) in AL amyloidosis. Leukemia. 2014 Dec;28(12):2304-10. doi: 10.1038/leu.2014.218. Epub 2014 Jul 16.