TriangleNCT03499808 · STUDY IN CONTEXT
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary 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. 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
To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. While OS was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants reached survival time of at least 24 months).
Duration of response is measure as time between hematologic response and hematologic progression. Hematologic progression is defined as 50% increase from nadir. While duration of response was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants achieved 24 month duration of response)
To evaluate time to hematologic response. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
To evaluate progression-free survival (24 month estimate) Hematologic progression is defined as 50% increase from nadir, or from baseline (if there was no response) in any ONE OR MORE of the following: 1. Serum M-protein: 50% increase in Serum M protein to a value greater than 0.5 g/dL. 2. Urine M protein: 50% increase in Urine M protein to a value greater than 200 mg/day (a visible peak must be present) 3. Free light chain increase of 50% to a value greater than 10 mg/dL
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-primary-systemic-amyloidosis
- nct id
- NCT03499808
- trial label
- S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary 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. 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- outcome key
- om-0000
- source section id
- NCT03499808-om-0000
- source outcome index
- 0
- endpoint
- Assess Efficacy by Confirmed Overall Hematologic Response
- endpoint definition
- To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
- time origin
- From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 35 participants who received treatment and are analyzable.
- 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
- NCT03499808
- outcome key
- om-0001
- source section id
- NCT03499808-om-0001
- source outcome index
- 1
- endpoint
- To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
- endpoint definition
- Only adverse events that are possibly, probably or definitely related to study drug are reported.
- time origin
- From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who completed at least one day of treatment.
- 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
- NCT03499808
- outcome key
- om-0002
- source section id
- NCT03499808-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (24 Month Estimate)
- endpoint definition
- Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. While OS was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants reached survival time of at least 24 months).
- time origin
- From date of enrollment up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 35 eligible participants who received at least one dose of study drug.
- 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
- NCT03499808
- outcome key
- om-0003
- source section id
- NCT03499808-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response (24 Month Estimate)
- endpoint definition
- Duration of response is measure as time between hematologic response and hematologic progression. Hematologic progression is defined as 50% increase from nadir. While duration of response was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants achieved 24 month duration of response)
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 27 participants with response to study treatment
- 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
- NCT03499808
- outcome key
- om-0004
- source section id
- NCT03499808-om-0004
- source outcome index
- 4
- endpoint
- Time to Hematologic Response
- endpoint definition
- To evaluate time to hematologic response. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
- time origin
- From registration to time of confirmed hematologic progression
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 35 analyzable participants, 27 achieved a response.
- 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
- NCT03499808
- outcome key
- om-0005
- source section id
- NCT03499808-om-0005
- source outcome index
- 5
- endpoint
- Progression-free Survival (24 Month Estimate)
- endpoint definition
- To evaluate progression-free survival (24 month estimate) Hematologic progression is defined as 50% increase from nadir, or from baseline (if there was no response) in any ONE OR MORE of the following: 1. Serum M-protein: 50% increase in Serum M protein to a value greater than 0.5 g/dL. 2. Urine M protein: 50% increase in Urine M protein to a value greater than 200 mg/day (a visible peak must be present) 3. Free light chain increase of 50% to a value greater than 10 mg/dL
- time origin
- From registration to time of confirmed hematologic progression
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 35 participants were analyzable
- 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
- NCT03499808
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Isatuximab
- regimen
- Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03499808-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Isatuximab
- regimen
- Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03499808-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Isatuximab
- regimen
- Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03499808-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Isatuximab
- regimen
- Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03499808-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Isatuximab
- regimen
- Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03499808-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Isatuximab
- regimen
- Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03499808-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-systemic-amyloidosis
- nct id
- NCT03499808
- harm key
- EG000
- source section id
- NCT03499808-ae
- event group key
- EG000
- event group label
- Isatuximab
- serious affected
- 15
- serious at risk
- 35
- other affected
- 32
- other at risk
- 35
- frequency threshold
- 5
- collection period
- Up to 4 years after registration
- event definition
- Participants who received protocol treatment and are eligible are included
- 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