An allocation by random phase II/III trial of doxycycline in comparison to standard therapy in newly-diagnosed cardiac AL amyloidosis patients with bortezomib-based therapy

A randomized phase II/III trial of doxycycline vs. standard supportive therapy in newly-diagnosed cardiac AL amyloidosis patients undergoing bortezomib-based therapy - ReDox

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002210-31-DE

Enrollment

120

Registered

2019-01-24

Start date

2019-05-31

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Light chain (AL) amyloidosis is a protein conformational disease, caused by a small bone marrow plasma cell clone producing light chains (LCs) that undergo conformational changes, aggregate and deposit in tissues in the form of amyloid fibrils. This process causes dysfunction of the organs involved and leads to death if not effectively treated.

Interventions

Trade Name: DoxyHEXAL® tabs 100 mg Tabletten Wirkstoff Doxycyclin Zugelassen ab 18. November 2018 Product Name: DoxyHEXAL® tabs 100 mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: DOXYCY

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • newly-diagnosed AL amyloidosis • stage II/IIIa heart involvement • age >18 years • planned bortezomib-based therapy • total bilirubin 1.5 × url without any other liver function test abnormalities are still eligible • alkaline phosphatase =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: non-AL amyloidosis · previous treatment for AL amyloidosis · pregnant or nursing women · uncontrolled infection · active malignancy · known hypersensitivity to doxycycline, bortezomib, boron, or mannitol · treatment with drugs potentially affecting doxycycline absorption · significant acute gastrointestinal symptoms · active peptic ulceration and/or esophageal reflux disease · contraindications to bortezomib based therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: The trial aims at establishing whether the addition of the antibiotic doxycycline to anti-plasma cell therapy can reduce early mortality in newly-diagnosed patients with cardiac AL amyloidosis. Cardiac involvement is responsible for almost all the early deaths in AL amyloidosis. Therapy solely aimed at the underlying disease can rescue only a minority of patients with cardiac AL amyloidosis, whose treatment remains a largely unmet need. The severity of cardiac involvement is accurately assessed by a staging system based on cardiac biomarkers. Patients with stage II/IIIa cardiac involvement will be enrolled in this study. ;Secondary Objective: Not applicable;Primary end point(s): proportion surviving at 12 months;Timepoint(s) of evaluation of this end point: 12 months after beginning of the Treatment phase	—

Measure

Time frame

Main Objective: The trial aims at establishing whether the addition of the antibiotic doxycycline to anti-plasma cell therapy can reduce early mortality in newly-diagnosed patients with cardiac AL amyloidosis. Cardiac involvement is responsible for almost all the early deaths in AL amyloidosis. Therapy solely aimed at the underlying disease can rescue only a minority of patients with cardiac AL amyloidosis, whose treatment remains a largely unmet need. The severity of cardiac involvement is accurately assessed by a staging system based on cardiac biomarkers. Patients with stage II/IIIa cardiac involvement will be enrolled in this study. ;Secondary Objective: Not applicable;Primary end point(s): proportion surviving at 12 months;Timepoint(s) of evaluation of this end point: 12 months after beginning of the Treatment phase

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Secondary

Measure	Time frame
Secondary end point(s): safety, i.e. rate of severe (CTCAE v5.0) grade 3 or greater adverse events) · rate of infective adverse events of any grade · cardiac response (as per consensus criteria) at 2, 4, 6 and 12 months · hematologic response (as per consensus criteria) at 2, 4, 6 and 12 months · renal response (as per consensus criteria) at 2, 4, 6 and 12 months;Timepoint(s) of evaluation of this end point: 12 months after beginning of the Treatment phase	—

Measure

Time frame

Secondary end point(s): safety, i.e. rate of severe (CTCAE v5.0) grade 3 or greater adverse events) · rate of infective adverse events of any grade · cardiac response (as per consensus criteria) at 2, 4, 6 and 12 months · hematologic response (as per consensus criteria) at 2, 4, 6 and 12 months · renal response (as per consensus criteria) at 2, 4, 6 and 12 months;Timepoint(s) of evaluation of this end point: 12 months after beginning of the Treatment phase

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Countries

Canada, Germany, Italy, Turkey

Contacts

Public ContactProfessor Dr. med. Ute Hegenbart

Universitätsklinikum Heidelberg

Ute.Hegenbart@med.uni-heidelberg.de490622156 8030

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026