Skip to content
Triangle logo TriangleGet started
← AL Amyloidosis

NCT02632786 · STUDY IN CONTEXT

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) 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

N-terminal pro-brain natriuretic peptide (NT-proBNP ) best response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment. Cardiac best response, as assessed by NT-proBNP alone, is defined as the most favorable category among response (ie, decrease in NT-proBNP from baseline of \>30% and \>300 ng/L), stable (ie, neither response nor progression), and progression (ie, increase in NT-proBNP from baseline of \>30% and \>300 ng/L) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Non-response is defined as either stable or progression.

ITT population

→

secondary · POSTED

Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.

ITT population

→

secondary · POSTED

Change in 6 Minute Walk Test (6MWT) Distance (meters)

ITT Population

→

secondary · POSTED

Proteinuria and estimated Glomerular Filtration Rate (eGFR) response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with renal involvement. Renal best response, as assessed by proteinuria, is defined as the most favorable category among response (ie, ≥30% decrease from baseline or \<0.5 g/24 hours postbaseline result if subject does not meet criteria for progression), stable (ie, neither response nor progression), and progression (ie, ≥25% decrease in eGFR from baseline) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Assessments that qualify as both a response and progression are counted as progression. Non-response is defined as either stable or progression.

Renal Evaluable Population

→

secondary · POSTED

Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) Total Score in subjects with peripheral nerve involvement. NIS-LL is a scoring system graduated from 0 points to a maximum of 88 points (the absence of all motor, sensory, and reflex activity in the lower extremities). The scale is an additive of all deficits (64 potential points for muscle strength, 8 points for reflexes, and 16 points for sensory function) in the lower extremities. A score of 0 is normal and score of 88 is total impairment.

Peripheral Neuropathy Evaluable Population

→

secondary · POSTED

Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.

ITT population

→

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

SF-36 / SF-12 · SF-36v2 PCS Score

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-al-amyloidosis
nct id
NCT02632786
qol key
qol-0001
source section id
NCT02632786-om-0001
source outcome index
1
instrument
SF-36 / SF-12
instrument basis
matched 'sf-36' in the study's own wording
scale title
SF-36v2 PCS Score
measure definition
Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.
time frame
Baseline to 12 months of treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · NT-proBNP Slope

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-al-amyloidosis
nct id
NCT02632786
qol key
qol-0005
source section id
NCT02632786-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
NT-proBNP Slope
measure definition
Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.
time frame
Baseline through 12 months of treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT02632786
trial label
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) 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
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0000
    source section id
    NCT02632786-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Cardiac Response and Non-Response
    endpoint definition
    N-terminal pro-brain natriuretic peptide (NT-proBNP ) best response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment. Cardiac best response, as assessed by NT-proBNP alone, is defined as the most favorable category among response (ie, decrease in NT-proBNP from baseline of \>30% and \>300 ng/L), stable (ie, neither response nor progression), and progression (ie, increase in NT-proBNP from baseline of \>30% and \>300 ng/L) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Non-response is defined as either stable or progression.
    time origin
    Baseline through 12 months of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0001
    source section id
    NCT02632786-om-0001
    source outcome index
    1
    endpoint
    SF-36v2 PCS Score
    endpoint definition
    Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.
    time origin
    Baseline to 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0002
    source section id
    NCT02632786-om-0002
    source outcome index
    2
    endpoint
    6MWT Distance
    endpoint definition
    Change in 6 Minute Walk Test (6MWT) Distance (meters)
    time origin
    Baseline to 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0003
    source section id
    NCT02632786-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With Renal Best Response and Non-Response
    endpoint definition
    Proteinuria and estimated Glomerular Filtration Rate (eGFR) response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with renal involvement. Renal best response, as assessed by proteinuria, is defined as the most favorable category among response (ie, ≥30% decrease from baseline or \<0.5 g/24 hours postbaseline result if subject does not meet criteria for progression), stable (ie, neither response nor progression), and progression (ie, ≥25% decrease in eGFR from baseline) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Assessments that qualify as both a response and progression are counted as progression. Non-response is defined as either stable or progression.
    time origin
    Baseline through 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Renal Evaluable Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0004
    source section id
    NCT02632786-om-0004
    source outcome index
    4
    endpoint
    NIS-LL Total Score
    endpoint definition
    Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) Total Score in subjects with peripheral nerve involvement. NIS-LL is a scoring system graduated from 0 points to a maximum of 88 points (the absence of all motor, sensory, and reflex activity in the lower extremities). The scale is an additive of all deficits (64 potential points for muscle strength, 8 points for reflexes, and 16 points for sensory function) in the lower extremities. A score of 0 is normal and score of 88 is total impairment.
    time origin
    Baseline to 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Peripheral Neuropathy Evaluable Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0005
    source section id
    NCT02632786-om-0005
    source outcome index
    5
    endpoint
    NT-proBNP Slope
    endpoint definition
    Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.
    time origin
    Baseline through 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0000
    arm key
    OG000
    arm label
    NEOD001 24mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0001
    arm key
    OG000
    arm label
    NEOD001 24mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0002
    arm key
    OG000
    arm label
    NEOD001 24 mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0003
    arm key
    OG000
    arm label
    NEOD001 24 mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0004
    arm key
    OG000
    arm label
    NEOD001 24 mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0005
    arm key
    OG000
    arm label
    NEOD001 24 mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02632786-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    harm key
    EG000
    source section id
    NCT02632786-ae
    event group key
    EG000
    event group label
    NEOD001 24 mg/kg
    serious affected
    14
    serious at risk
    66
    other affected
    58
    other at risk
    66
    frequency threshold
    5
    collection period
    Initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever is later
    event definition
    AE that newly appears, increases in frequency, or worsens in severity following initiation of study drug and through the last study visit or up to 30
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    harm key
    EG001
    source section id
    NCT02632786-ae
    event group key
    EG001
    event group label
    Placebo
    serious affected
    15
    serious at risk
    63
    other affected
    52
    other at risk
    63
    frequency threshold
    5
    collection period
    Initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever is later
    event definition
    AE that newly appears, increases in frequency, or worsens in severity following initiation of study drug and through the last study visit or up to 30
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    qol key
    qol-0001
    source section id
    NCT02632786-om-0001
    source outcome index
    1
    instrument
    SF-36 / SF-12
    instrument basis
    matched 'sf-36' in the study's own wording
    scale title
    SF-36v2 PCS Score
    measure definition
    Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.
    time frame
    Baseline to 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT02632786
    qol key
    qol-0005
    source section id
    NCT02632786-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    NT-proBNP Slope
    measure definition
    Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.
    time frame
    Baseline through 12 months of treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population
    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