NCT02207556

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 whether doxycycline improves the response to standard anti-amyloid therapy and whether it causes any problems (side effects).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

July 9, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

July 23, 2014

Results QC Date

December 18, 2019

Last Update Submit

June 18, 2021

Conditions

Primary Systemic Amyloidosis

Keywords

AL amyloidosisamyloidosislight chain amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Hematologic Response

    This measure will record the number of subjects for each grade of response to therapy for subjects with Systematic Disease (hematologic) only. Hematologic response will be determined as follows. Complete response (CR) - Negative serum/urine immunofixation with normal Free Light Chain (FLC) ratio Very Good Partial Response (VGPR)- Difference between involved and uninvolved FLCs (dFLC) \< 40 mg/L Partial Response (PR)- dFLC decrease \> 50% No Response (NR)- less then PR.

    1 year

Secondary Outcomes (4)

  • Amyloid Organ Response

    6 months and 1 year

  • Mortality

    Baseline, 3 months, 6 months, 1 year

  • Patient-reported Health Quality of Life

    Baseline, 3, 6, 9 and 12 months

  • Patient-reported Mental Quality of Life

    Baseline, 3, 6, 9 and 12 months

Study Arms (1)

Doxycycline

EXPERIMENTAL

Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.

Drug: Doxycycline

Interventions

DoxycyclineDRUG

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.

Also known as: Doxycycline monohydrate
Doxycycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • D'Souza A, Szabo A, Flynn KE, Dhakal B, Chhabra S, Pasquini MC, Weihrauch D, Hari PN. Adjuvant doxycycline to enhance anti-amyloid effects: Results from the dual phase 2 trial. EClinicalMedicine. 2020 Jun 5;23:100361. doi: 10.1016/j.eclinm.2020.100361. eCollection 2020 Jun.

    PMID: 32529175DERIVED

MeSH Terms

Conditions

Immunoglobulin Light-chain AmyloidosisAmyloidosis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Dr. Anita D'Souza
Organization
Medical College of Wisconsin
dsouza@mcw.edu
414-805-0637

Study Officials

  • Anita D'Souza, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2014

First Posted

August 4, 2014

Study Start

October 1, 2014

Primary Completion

July 31, 2017

Study Completion

May 19, 2020

Last Updated

July 9, 2021

Results First Posted

January 7, 2020

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)