Phase 2
N=32
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Primary Systemic Amyloidosis
Bottom Line
View on ClinicalTrials.gov: NCT02207556 ↗Enrolled (actual)
32
Serious AEs
46.7%
Results posted
Jan 2020
Primary outcome: Primary: Hematologic Response — 6; 3; 11; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxycycline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematologic Response |
6; 3; 11; 5 | — |
| SECONDARY Amyloid Organ Response |
8; 3; 8; 8; 6; 9 | — |
| SECONDARY Mortality |
6; 25; 6; 23; 6; 22 | — |
| SECONDARY Patient-reported Health Quality of Life |
46.1; 40.9; 51.1; 40.2; 48.3; 40.6 | — |
| SECONDARY Patient-reported Mental Quality of Life |
52.1; 47.9; 51.4; 46.0; 51.2; 46.4 | — |
Summary
In this study the investigators want to find out more about the addition of the antibiotic, doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators want to find out whether doxycycline improves the response to standard anti-amyloid therapy and whether it causes any problems (side effects).
Eligibility Criteria
Inclusion Criteria
- Patients with biopsy proven AL amyloidosis.
- Patients ≥ 18 years of age are eligible.
- Patient must provide informed consent.
- All patients must have measurable amyloid organ involvement of a vital organ (eg. heart, liver, kidneys). Localized amyloidosis will also be eligible as long as the amyloid involvement is radiologically measurable.
- A negative pregnancy test will be required for all women of child bearing potential. Breast feeding is not permitted.
- Patients who have previously been taking doxycycline will be eligible as long as there is no contraindication to stay on doxycycline 100 mg twice daily (BID) for 1 year in the opinion of the treating physician.
- Creatinine clearance of >25 ml/min.
Exclusion Criteria
- Patients with severe malabsorption syndrome precluding absorption of oral agents will be excluded.
- Known intolerance or allergic reactions with doxycycline.
- Previous chemotherapy for AL amyloidosis.
Data sourced from ClinicalTrials.gov (NCT02207556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.