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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-21

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyloidosis; Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxycycline/BCD chemotherapy

Doxycycline combined with bortezomib-cyclophosphamide-dexamethasone chemotherapy

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Oral doxycycline 100mg twice daily

Bortezomib

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

BCD chemotherapy

Bortezomib-cyclophosphamide-dexamethasone chemotherapy

Group Type ACTIVE_COMPARATOR

Bortezomib

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Interventions

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Doxycycline

Oral doxycycline 100mg twice daily

Intervention Type DRUG

Bortezomib

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No