Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Completed · Phase 2
Conditions studied: Primary Systemic Amyloidosis
In brief
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).
Key facts
- Study ID
- NCT02207556
- Run by
- Medical College of Wisconsin
- People needed
- 32
- Starts
- 2014-10-01
- Expected to finish
- 2020-05-19
- Last updated by the study team
- 2021-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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