TriangleNCT02207556 · STUDY IN CONTEXT
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
The number of living subjects will be determined at Baseline, 3 months, 6 months and 1 year
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.
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.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Patient-reported Health Quality of Life
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- qol key
- qol-0003
- source section id
- NCT02207556-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Patient-reported Health Quality of Life
- measure definition
- 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.
- time frame
- Baseline, 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Patient-reported Mental Quality of Life
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- qol key
- qol-0004
- source section id
- NCT02207556-om-0004
- source outcome index
- 4
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Patient-reported Mental Quality of Life
- measure definition
- 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.
- time frame
- Baseline, 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- trial label
- Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 2
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0000
- source section id
- NCT02207556-om-0000
- source outcome index
- 0
- endpoint
- Hematologic Response
- endpoint definition
- 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.
- time origin
- 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0001
- source section id
- NCT02207556-om-0001
- source outcome index
- 1
- endpoint
- Amyloid Organ Response
- endpoint definition
- 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.
- time origin
- 6 months and 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0002
- source section id
- NCT02207556-om-0002
- source outcome index
- 2
- endpoint
- Mortality
- endpoint definition
- The number of living subjects will be determined at Baseline, 3 months, 6 months and 1 year
- time origin
- Baseline, 3 months, 6 months, 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0003
- source section id
- NCT02207556-om-0003
- source outcome index
- 3
- endpoint
- Patient-reported Health Quality of Life
- endpoint definition
- 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.
- time origin
- Baseline, 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0004
- source section id
- NCT02207556-om-0004
- source outcome index
- 4
- endpoint
- Patient-reported Mental Quality of Life
- endpoint definition
- 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.
- time origin
- Baseline, 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Doxycycline (Systemic Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Doxycycline (6 Months)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Doxycycline (1 Year)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Doxycycline (Localized Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Doxacycline (Systemic Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Doxycycline (Localized Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Doxacycline (Systemic Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Doxycycline (Localized Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Doxacycline (Systemic Disease)
- regimen
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. 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.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02207556-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- harm key
- EG000
- source section id
- NCT02207556-ae
- event group key
- EG000
- event group label
- Doxycycline (Localized Disease)
- serious affected
- 1
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- 1 year
- event definition
- Grade was determined using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. Events graded as 4 or 5 were considered serious regardless of the standard criteria.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- harm key
- EG001
- source section id
- NCT02207556-ae
- event group key
- EG001
- event group label
- Doxycycline (Systemic Disease)
- serious affected
- 13
- serious at risk
- 25
- other affected
- 24
- other at risk
- 25
- frequency threshold
- 5
- collection period
- 1 year
- event definition
- Grade was determined using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. Events graded as 4 or 5 were considered serious regardless of the standard criteria.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- qol key
- qol-0003
- source section id
- NCT02207556-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Patient-reported Health Quality of Life
- measure definition
- 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.
- time frame
- Baseline, 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT02207556
- qol key
- qol-0004
- source section id
- NCT02207556-om-0004
- source outcome index
- 4
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Patient-reported Mental Quality of Life
- measure definition
- 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.
- time frame
- Baseline, 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice