Status:
COMPLETED
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Primary Systemic Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Organ response to anti-plasma cell therapy in AL amyloidosis tends to lags behind hematologic response as chemotherapy may not clear pre-formed organ amyloid. Doxycycline has been shown to have inhibi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02207556
Start Date
October 1 2014
End Date
May 19 2020
Last Update
July 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226