TriangleNCT00520767 · STUDY IN CONTEXT
Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
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
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- trial label
- Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- outcome key
- om-0000
- source section id
- NCT00520767-om-0000
- source outcome index
- 0
- endpoint
- Complete Hematologic Response
- endpoint definition
- Complete Hematologic Response
- time origin
- Up to 12 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Individuals evaluable for response
- 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
- NCT00520767
- outcome key
- om-0001
- source section id
- NCT00520767-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- time from day of registration until day of death.
- time origin
- time from day of registration until 72 months.
- 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
- NCT00520767
- outcome key
- om-0002
- source section id
- NCT00520767-om-0002
- source outcome index
- 2
- endpoint
- Time to Treatment Failure (TTF)
- endpoint definition
- Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause.
- time origin
- start of treatment until 72 months
- 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
- NCT00520767
- outcome key
- om-0003
- source section id
- NCT00520767-om-0003
- source outcome index
- 3
- endpoint
- Organ Response Rate (OrR)
- endpoint definition
- Organ Response Rate (OrR)
- time origin
- Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not collected not analyzed.
- 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
- NCT00520767
- outcome key
- om-0004
- source section id
- NCT00520767-om-0004
- source outcome index
- 4
- endpoint
- Overall Hematologic Response Rate (OHR)
- endpoint definition
- Overall Hematologic Response Rate (OHR)
- time origin
- Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not collected not analyzed.
- 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
- NCT00520767
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Melphalan, Dexamethasone, Bortezomib,
- regimen
- Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00520767-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Melphalan, Dexamethasone, Bortezomib,
- regimen
- Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00520767-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Melphalan, Dexamethasone, Bortezomib,
- regimen
- Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00520767-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Melphalan, Dexamethasone, Bortezomib,
- regimen
- Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00520767-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Melphalan, Dexamethasone, Bortezomib,
- regimen
- Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00520767-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT00520767
- harm key
- EG000
- source section id
- NCT00520767-ae
- event group key
- EG000
- event group label
- Melphalan, Dexamethasone, Bortezomib,
- serious affected
- 12
- serious at risk
- 35
- other affected
- 3
- other at risk
- 35
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- 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
- setting source links
Preserved source evidence · Not medical advice