Trial · NCT02207556
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
NCT02207556, Phase 2, Completed, Medical College of Wisconsin; results first posted 2020-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial. Trials, record NCT02207556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02207556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
- NCT number
- NCT02207556
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Primary Systemic Amyloidosis
- Interventions
- Doxycycline
- First posted
- 2014-08-04
- Last updated
- 2021-07-09
- Results first posted
- 2020-01-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematologic Response | 1 year | 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. |
| Secondary | Amyloid Organ Response | 6 months and 1 year | This measure is the number of subjects (systemic disease only) for each grade of response. Efficacy will be measured in heart, liver, or kidney. Heart N-terminal (NT)-proBNP response \>30% and \> 300 ng/L decrease in patients with baseline NT-proBNP ≥650 ng/L (Patients with progressively worsening renal function cannot be scored for NT-proBNP progression). Improvement by 2 New York Heart Association (NYHA) classes without an increase in diuretic use or in echocardiographic wall thickness ≥ 2 mm reduction in the interventricular septal thickness by echocardiogram or improvement of ejection fraction by ≥20%. Liver ≥50% decrease in an initially elevated alkaline phosphatase level, or Decrease in liver size by at least 2 cm by ultrasound. Kidney 50% reduction in 24-hour urine protein excretion (at least 0.5 g/day) without worsening of creatinine or creatinine clearance by 25% over baseline. Soft Tissue RECIST criteria will be used. |
| Secondary | Mortality | Baseline, 3 months, 6 months, 1 year | The number of living subjects will be determined at Baseline, 3 months, 6 months and 1 year |
| Secondary | Patient-reported Health Quality of Life | Baseline, 3, 6, 9 and 12 months | Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the physical health score. T-scores for this domain range from 16.2 to 67.7. Higher scores indicate poorer physical health. |
| Secondary | Patient-reported Mental Quality of Life | Baseline, 3, 6, 9 and 12 months | Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the mental health score. T-scores for this domain range from 21.2 to 67.6. Higher scores indicate poorer mental health. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hematologic Response | 1 year | Hematologic response is not relevant to subjects with localized disease. Subjects with localized disease were not included in this analysis. Five participants had expired by the 1 year time point | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Amyloid Organ Response | 6 months and 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality | Baseline, 3 months, 6 months, 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient-reported Health Quality of Life | Baseline, 3, 6, 9 and 12 months | One subject in the Localized cohort withdrew consent prior to the 6-month visit. Five subjects in the Systemic Disease cohort expired during the course of the study; two subjects came off study; and one was lost to follow-up. | score on a scale | MEAN |
| SECONDARY | Patient-reported Mental Quality of Life | Baseline, 3, 6, 9 and 12 months | One subject in the Localized cohort withdrew consent prior to the 6-month visit. Five subjects in the Systemic Disease cohort expired during the course of the study; two subjects came off study; and one was lost to follow-up. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hematologic Response | Doxycycline (Systemic Disease) | Complete Response (CR) | 6 | Participants | |
| Hematologic Response | Doxycycline (Systemic Disease) | Partial Response (PR) | 3 | Participants | |
| Hematologic Response | Doxycycline (Systemic Disease) | Very Good Partial Response (VGPR) | 11 | Participants | |
| Hematologic Response | Doxycycline (Systemic Disease) | Expired at 1 year | 5 | Participants | |
| Amyloid Organ Response | Doxycycline (6 Months) | Progressive Disease | 8 | Participants | |
| Amyloid Organ Response | Doxycycline (1 Year) | Progressive Disease | 3 | Participants | |
| Amyloid Organ Response | Doxycycline (6 Months) | Stable Disease | 8 | Participants | |
| Amyloid Organ Response | Doxycycline (1 Year) | Stable Disease | 8 | Participants | |
| Amyloid Organ Response | Doxycycline (6 Months) | Response | 6 | Participants | |
| Amyloid Organ Response | Doxycycline (1 Year) | Response | 9 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxycycline (Localized Disease) | 7 | |
| Overall Study | STARTED | Doxacycline (Systemic Disease) | 25 | |
| Overall Study | COMPLETED | Doxycycline (Localized Disease) | 5 | |
| Overall Study | COMPLETED | Doxacycline (Systemic Disease) | 20 | |
| Overall Study | NOT COMPLETED | Doxycycline (Localized Disease) | 2 | |
| Overall Study | NOT COMPLETED | Doxacycline (Systemic Disease) | 5 |
Source ClinicalTrials.gov
Adverse events310
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Doxycycline (Localized Disease) | 3 | 5 | 3 |
| other | Fatigue | General disorders | Doxycycline (Systemic Disease) | 15 | 25 | 15 |
| other | Hypertension | Vascular disorders | Doxycycline (Localized Disease) | 3 | 5 | 3 |
| other | Hypertension | Vascular disorders | Doxycycline (Systemic Disease) | 6 | 25 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Doxycycline (Localized Disease) | 2 | 5 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Doxycycline (Systemic Disease) | 5 | 25 | 5 |
| other | Bruising | Injury, poisoning and procedural complications | Doxycycline (Localized Disease) | 2 | 5 | 2 |
| other | Bruising | Injury, poisoning and procedural complications | Doxycycline (Systemic Disease) | 8 | 25 | 8 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Doxycycline (Localized Disease) | 2 | 5 | 2 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Doxycycline (Systemic Disease) | 12 | 25 | 12 |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxycycline (Localized Disease) | 0 | 5 |
| Total, all-cause mortality | Doxycycline (Systemic Disease) | 5 | 25 |
| Total, other adverse events | Doxycycline (Localized Disease) | 5 | 5 |
| Total, other adverse events | Doxycycline (Systemic Disease) | 24 | 25 |
| Total, serious adverse events | Doxycycline (Localized Disease) | 1 | 5 |
| Total, serious adverse events | Doxycycline (Systemic Disease) | 13 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32529175 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| KL2TR001438 | Institutional Career Development Core | WIDLANSKY, MICHAEL E | MEDICAL COLLEGE OF WISCONSIN | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2015 to 2024 | NIH RePORTER |
| K23HL141445 | Development and validation of a disease-relevant patient-reported outcome tool in light chain amyloidosis | D'SOUZA, ANITA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2019 to 2022 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doxycycline (Localized Disease) vs Doxycycline (Systemic Disease): deaths from any cause | Trial comparisons |
| Doxycycline (Localized Disease) vs Doxycycline (Systemic Disease): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02207556
GET https://conductscience.org/api/trials/v1/NCT02207556/results?page=2