NCT01072773 · STUDY IN CONTEXT

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.

Source null

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secondary · POSTED

Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.

Source null

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secondary · POSTED

The number of patients that acheived a response in an affected organ.

Source null

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secondary · POSTED

Survival time is defined as the time from registration to death due to any cause.

Source null

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secondary · POSTED

Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death

Source null

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secondary · POSTED

Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.

Neither participant achieved a response. Therefore, no duration of response calculation was performed.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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: NCT01072773
trial label: Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis
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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0000
source section id
NCT01072773-om-0000
source outcome index
0
endpoint
Number of Participants With a Confirmed Hematologic Response
endpoint definition
Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
time origin
Duration of treatment (up to 12 cycles/months)
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-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0001
source section id
NCT01072773-om-0001
source outcome index
1
endpoint
Number of Participants With Treatment Related Adverse Events.
endpoint definition
Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
time origin
Duration on treatment (up to 12 cycles/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
NCT01072773
outcome key
om-0002
source section id
NCT01072773-om-0002
source outcome index
2
endpoint
Number of Participants With an Organ Response.
endpoint definition
The number of patients that acheived a response in an affected organ.
time origin
Duration on treatment (up to 12 cycles/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
NCT01072773
outcome key
om-0003
source section id
NCT01072773-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Survival time is defined as the time from registration to death due to any cause.
time origin
Duration of Study (up to 5 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-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0004
source section id
NCT01072773-om-0004
source outcome index
4
endpoint
Time to Disease Progression
endpoint definition
Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death
time origin
Duration of Study (up to 5 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-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0005
source section id
NCT01072773-om-0005
source outcome index
5
endpoint
Duration of Response
endpoint definition
Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.
time origin
Duration of Study (up to 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Neither participant achieved a response. Therefore, no duration of response calculation was performed.
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
NCT01072773
outcome key
om-0000
arm key
OG000
arm label
Bortez/Cyc/Dex
regimen
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01072773-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0001
arm key
OG000
arm label
Bortez/Cyc/Dex
regimen
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01072773-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0002
arm key
OG000
arm label
Bortez/Cyc/Dex
regimen
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01072773-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0003
arm key
OG000
arm label
Bortez/Cyc/Dex
regimen
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01072773-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0004
arm key
OG000
arm label
Bortez/Cyc/Dex
regimen
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01072773-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
outcome key
om-0005
arm key
OG000
arm label
Bortez/Cyc/Dex
regimen
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01072773-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-primary-systemic-amyloidosis
nct id
NCT01072773
harm key
EG000
source section id
NCT01072773-ae
event group key
EG000
event group label
Bortez/Cyc/Dex
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
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