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Amyloidosis; SystemicNCT03401372

BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients

A study testing Doxycycline, Bortezomib and Cyclophosphamide in people with Amyloidosis; Systemic, run by Jian Li at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloidosis; Systemic
What is being tested?
Doxycycline, Bortezomib and Cyclophosphamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
21 Apr 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years old adults.
  • Biopsy proved treatment-naïve pAL amyloidosis.
  • Mayo 2004 stage II-III.
  • dFLC > 50mg/L.
  • Patient must provide informed consent.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, 100730

Other trials in China

About this study

Official title: 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

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.

Being tested
Doxycycline, Bortezomib, Cyclophosphamide, Dexamethasone
Keywords
Primary light chain amyloidosis, Doxycycline, Bortezomib, Prognosis, Progression-free survival, Overall survival, Organ response
Medical subject headings
Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxycyclineDrug

    Oral doxycycline 100mg twice daily

  • BortezomibDrug

    1.3mg/m2 of bortezomib on days 1, 8, 15 and 22 of a 35-day cycle

  • CyclophosphamideDrug

    300mg/m2 cyclophosphamide on days 1, 8, 15 and 22 of a 35-day cycle

  • DexamethasoneDrug

    40mg of dexamethasone on days 1, 8, 15 and 22 of a 35-day cycle

Study groups in NCT03401372
Study groupRoleWhat they receive
Doxycycline/BCD chemotherapyExperimentalDoxycycline combined with bortezomib-cyclophosphamide-dexamethasone chemotherapy
Receives: Drug: Doxycycline; Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone
BCD chemotherapyActive comparatorBortezomib-cyclophosphamide-dexamethasone chemotherapy
Receives: Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The patients are assessed after each cycle of chemotherapy following treatment initiation until progression, relapse, death or study closure at 24-month follow-up.

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival

    The patients are assessed after each cycle of chemotherapy following treatment initiation until progression, relapse, death or study closure at 24-month follow-up. If the primary endpoint has reached, patients will also be followed up every 3 months thereafter until death or study closure.

    Measured: 2 years

  2. Hematologic response

    The patients are assessed after each cycle of chemotherapy following treatment initiation until progression, relapse, death or study closure at 24-month follow-up. If the primary endpoint has reached, patients will also be followed up every 3 months thereafter until death or study closure.

    Measured: 2 years

  3. Organ response

    The patients are assessed after each cycle of chemotherapy following treatment initiation until progression, relapse, death or study closure at 24-month follow-up. If the primary endpoint has reached, patients will also be followed up every 3 months thereafter until death or study closure.

    Measured: 2 years

  4. Adverse events

    Adverse events are collected until 30 days after last dose of doxycycline.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start21 Apr 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401372
Sponsor's protocol ID
PUMCH-AL2017
Status last verified
Feb 2021
First submitted
9 Jan 2018
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ward 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.

    PubMed 21998211

  • Shen 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.

    PubMed 26117060

  • Feng 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.

    PubMed 28279033

  • Dispenzieri 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.

    PubMed 15365071

  • Mikhael 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.

    PubMed 22331188

  • Venner 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.

    PubMed 25027514

  • Kastritis E, Roussou M, Gavriatopoulou M, Migkou M, Kalapanida D, Pamboucas C, Kaldara E, Ntalianis A, Psimenou E, Toumanidis ST, Tasidou A, Terpos E, Dimopoulos MA. Long-term outcomes of primary systemic light chain (AL) amyloidosis in patients treated upfront with bortezomib or lenalidomide and the importance of risk adapted strategies. Am J Hematol. 2015 Apr;90(4):E60-5. doi: 10.1002/ajh.23936. Epub 2015 Mar 9.

    PubMed 25580702

  • Shen KN, Fu WJ, Wu Y, Dong YJ, Huang ZX, Wei YQ, Li CR, Sun CY, Chen Y, Miao HL, Zhang YL, Cao XX, Zhou DB, Li J. Doxycycline Combined With Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis: A Multicenter Randomized Controlled Trial. Circulation. 2022 Jan 4;145(1):8-17. doi: 10.1161/CIRCULATIONAHA.121.055953. Epub 2021 Sep 10.

    PubMed 34503349

Questions about this trial

What is this clinical trial studying?

A study testing Doxycycline, Bortezomib and Cyclophosphamide in people with Amyloidosis; Systemic, run by Jian Li at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401372, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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