CompletedPhase 2

Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial

United States32 participantsStarted 2014-10-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Hematologic Response

Timeframe: 1 year

Trial details

NCT IDNCT02207556

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-31

Results submitted2019-12-18

View on ClinicalTrials.gov More Primary Systemic Amyloidosis trials