TriangleNCT02489500 · STUDY IN CONTEXT
Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
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
Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains
Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
duration of overall survival measured in days
analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver.
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-al-amyloidosis
- nct id
- NCT02489500
- trial label
- Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
- 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
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0000
- source section id
- NCT02489500-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Hematologic Response
- endpoint definition
- Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains
- time origin
- 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable as they expired and did not have a post-treatment response evaluation.
- 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-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0001
- source section id
- NCT02489500-om-0001
- source outcome index
- 1
- endpoint
- Toxicities
- endpoint definition
- Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
- time origin
- 100 days
- 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-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0002
- source section id
- NCT02489500-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- duration of overall survival measured in days
- time origin
- 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed.
- 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-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0003
- source section id
- NCT02489500-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Organ Response
- endpoint definition
- analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver.
- time origin
- 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Due to early termination, organ response data was not collected.
- 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-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Melphalan
- regimen
- Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Melphalan + Bortezomib
- regimen
- Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Melphalan
- regimen
- Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Melphalan + Bortezomib
- regimen
- Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Melphalan
- regimen
- Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Melphalan + Bortezomib
- regimen
- Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Melphalan
- regimen
- Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Melphalan + Bortezomib
- regimen
- Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02489500-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-al-amyloidosis
- nct id
- NCT02489500
- harm key
- EG000
- source section id
- NCT02489500-ae
- event group key
- EG000
- event group label
- Melphalan
- serious affected
- 2
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- 3 months
- event definition
- Adverse event data were collected from the time of study entry through the date of program discharge, once blood cell counts returned to normal.
- 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-al-amyloidosis
- nct id
- NCT02489500
- harm key
- EG001
- source section id
- NCT02489500-ae
- event group key
- EG001
- event group label
- Melphalan + Bortezomib
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- 3 months
- event definition
- Adverse event data were collected from the time of study entry through the date of program discharge, once blood cell counts returned to normal.
- 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