Skip to main content
OpenTrials
Completed

NCT Number: NCT03401372

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amyloidosis; Systemic Amyloidosis Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxycycline

Drug

Oral doxycycline 100mg twice daily

bortezomib

Drug

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

Cyclophosphamide

Drug

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

Dexamethasone

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years

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

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

    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.

  2. Hematologic response

    Time frame: 2 years

    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.

  3. Organ response

    Time frame: 2 years

    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.

  4. Adverse events

    Time frame: up to 2 years

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

Sponsors and collaborators

Lead sponsor

Jian Li

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Chao Yang Hospital
  • Nanfang Hospital, Southern Medical University
  • Peking University First Hospital
  • Shanghai Changzheng Hospital
  • Tongji Hospital
  • Union Hospital Affiliated with Tongji Medical College of HUST
  • West China Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 17, 2018
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.