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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 Response

Mortality

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

Page last updated: August 23, 2015

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