Oral Doxycycline Administered as an Adjunct to Plasma Cell Directed Therapy in Light Chain Amyloidosis
Information source: Medical College of Wisconsin
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Systemic Amyloidosis
Intervention: Doxycycline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Medical College of Wisconsin Official(s) and/or principal investigator(s): Anita D'Souza, MD, Principal Investigator, Affiliation: Medical College of Wisconsin
Overall contact: Medical College of Wisconsin Clinical Cancer Center, Phone: 414-805-8900, Email: cccto@mcw.edu
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).
Clinical Details
Official title: A Phase II Open Label Study of Oral Doxycycline Administered as an Adjunct to Plasma Cell Directed Therapy in Light Chain (AL) Amyloidosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy measured by amyloid organ response
Secondary outcome: Hematologic ResponseMortality Composite measure of Patient reported Outcomes Safety
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 inhibitory effects on amyloid fibril formation as well as
de-fibrillogenic effects and shown to be beneficial in in vitro, murine models and other
preclinical studies. The investigators will prospectively evaluate the safety and efficacy
of doxycycline in AL amyloidosis patients when used in conjunction with anti-plasma cell
chemotherapy.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with biopsy proven AL amyloidosis.
2. Patients aged 18-75 years of age are eligible.
3. Patient must provide informed consent.
4. 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.
5. A negative pregnancy test will be required for all women of child bearing potential.
Breast feeding is not permitted.
6. Patients who have previously been taking doxycyline will be eligible as long as there
is no contraindication to stay on doxycycline 100 mg BID for 1 year in the opinion of
the treating physician.
7. Creatinine clearance of >25 ml/min.
Exclusion Criteria:
1. Patients with severe malabsorption syndrome precluding absorption of oral agents will
be excluded.
2. Known intolerance or allergic reactions with doxycycline.
3. Previous chemotherapy for AL amyloidosis.
Locations and Contacts
Medical College of Wisconsin Clinical Cancer Center, Phone: 414-805-8900, Email: cccto@mcw.edu
Froedtert & Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Additional Information
Starting date: October 2014
Last updated: June 18, 2015
|