NCT02207556

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

Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis (DUAL) Trial: A Phase II Open Label Study of Oral Doxycycline Administered as an Adjunct to Plasma Cell Directed Therapy in Light Chain (AL) Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Primary Systemic Amyloidosis

Interventions

Type	Name	Description
DRUG	Doxycycline	Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-07-31
• Completion: 2020-05-19
• First posted: 2014-08-04
• Last updated: 2021-07-09
• Results posted: 2020-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study