NCT02841033 · STUDY IN CONTEXT

Daratumumab for the Treatment of Patients With 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

Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L, a PR is dFLC reduction by \>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \>100 mg/L. \* "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.

Source null

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secondary · POSTED

Number of months from study drug initiation to starting another treatment

Source null

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secondary · POSTED

Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L; and a PR is dFLC reduction by \>50%. \* "dFLC" is difference in involved and uninvolved serum free light-chain levels

Source null

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secondary · POSTED

Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (\>30% and \>300 ng/L decrease in patients with a baseline NT-proBNP \>650 ng/L; and/or NYHA class response (\> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by \> 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline

19 evaluable patients with cardiac and/or renal involvement.

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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-al-amyloidosis
nct id: NCT02841033
trial label: Daratumumab for the Treatment of Patients With 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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT02841033
outcome key
om-0000
source section id
NCT02841033-om-0000
source outcome index
0
endpoint
Assess the Number of Patients Who Respond to Treatment
endpoint definition
Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L, a PR is dFLC reduction by \>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \>100 mg/L. \* "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.
time origin
3 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-al-amyloidosis
nct id
NCT02841033
outcome key
om-0001
source section id
NCT02841033-om-0001
source outcome index
1
endpoint
Time to Next Treatment
endpoint definition
Number of months from study drug initiation to starting another treatment
time origin
Up to 3 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-al-amyloidosis
nct id
NCT02841033
outcome key
om-0002
source section id
NCT02841033-om-0002
source outcome index
2
endpoint
Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria
endpoint definition
Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L; and a PR is dFLC reduction by \>50%. \* "dFLC" is difference in involved and uninvolved serum free light-chain levels
time origin
3 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-al-amyloidosis
nct id
NCT02841033
outcome key
om-0003
source section id
NCT02841033-om-0003
source outcome index
3
endpoint
Assess Organ Responses Based on Standard Criteria Included in Protocol
endpoint definition
Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (\>30% and \>300 ng/L decrease in patients with a baseline NT-proBNP \>650 ng/L; and/or NYHA class response (\> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by \> 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline
time origin
3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
19 evaluable patients with cardiac and/or renal involvement.
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
NCT02841033
outcome key
om-0000
arm key
OG000
arm label
Daratumumab
regimen
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02841033-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT02841033
outcome key
om-0001
arm key
OG000
arm label
Daratumumab
regimen
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02841033-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT02841033
outcome key
om-0002
arm key
OG000
arm label
Daratumumab
regimen
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02841033-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT02841033
outcome key
om-0003
arm key
OG000
arm label
Daratumumab
regimen
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02841033-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT02841033
harm key
EG000
source section id
NCT02841033-ae
event group key
EG000
event group label
Daratumumab
serious affected
11
serious at risk
22
other affected
22
other at risk
22
frequency threshold
5
collection period
First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
event definition
Adverse events were assessed at every study treatment visit.
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