TriangleNCT01383759 · STUDY IN CONTEXT
Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Depo
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
\[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; \<5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved \[iFLC\] and uninvolved FLC) to\<4mg/dl) and Partial Response (PR)\] (\>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.
12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
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-light-chain-deposition-disease
- nct id
- NCT01383759
- trial label
- Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Depo
- 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0000
- source section id
- NCT01383759-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Experiencing Progression Free Survival at 12 Months
- endpoint definition
- of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- time origin
- 12 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data were not collected for MIDD group.
- 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-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0001
- source section id
- NCT01383759-om-0001
- source outcome index
- 1
- endpoint
- Participants Evaluated for Toxicity
- endpoint definition
- Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
- time origin
- 2 years
- analysis role
- primary
- 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-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0002
- source section id
- NCT01383759-om-0002
- source outcome index
- 2
- endpoint
- To Estimate the Hematologic Response Rate
- endpoint definition
- \[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; \<5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved \[iFLC\] and uninvolved FLC) to\<4mg/dl) and Partial Response (PR)\] (\>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.
- time origin
- 2 years
- 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-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0003
- source section id
- NCT01383759-om-0003
- source outcome index
- 3
- endpoint
- Organ Response - Cardiac Involvement at 12 Months
- endpoint definition
- 12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- time origin
- 12 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-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0004
- source section id
- NCT01383759-om-0004
- source outcome index
- 4
- endpoint
- Progression Free Survival at 24 Months
- endpoint definition
- following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- time origin
- 24 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-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0005
- source section id
- NCT01383759-om-0005
- source outcome index
- 5
- endpoint
- Organ Response - Cardiac Involvement at 24 Months
- endpoint definition
- 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
- time origin
- 24 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Amyloidosis
- regimen
- Participants with newly diagnosed AL amyloidosis
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Amyloidosis
- regimen
- Participants with newly diagnosed AL amyloidosis
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Monoclonal Ig DepositionDisease (MIDD)
- regimen
- Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Amyloidosis
- regimen
- Participants with newly diagnosed AL amyloidosis
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Monoclonal Ig DepositionDisease (MIDD)
- regimen
- Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Amyloidosis
- regimen
- Participants with newly diagnosed AL amyloidosis
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Amyloidosis
- regimen
- Participants with newly diagnosed AL amyloidosis
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Amyloidosis
- regimen
- Participants with newly diagnosed AL amyloidosis
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01383759-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- harm key
- EG000
- source section id
- NCT01383759-ae
- event group key
- EG000
- event group label
- Amyloidosis
- serious affected
- 17
- serious at risk
- 19
- other affected
- 19
- other at risk
- 19
- frequency threshold
- 5
- collection period
- 1 year
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01383759
- harm key
- EG001
- source section id
- NCT01383759-ae
- event group key
- EG001
- event group label
- Monoclonal Ig DepositionDisease (MIDD)
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- 1 year
- 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