Trial · NCT03499808
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
NCT03499808, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2025-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis. Trials, record NCT03499808. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03499808
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
- NCT number
- NCT03499808
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
Amorphous, Eosinophilic, and Acellular Deposit, Constipation, Diarrhea, Early Satiety, Gastrointestinal Hemorrhage, Hepatomegaly, Lymphadenopathy, Macroglossia, Nausea, Primary Systemic Amyloidosis, Purpura, Recurrent Primary Amyloidosis, Refractory Primary Amyloidosis
- Interventions
- Isatuximab, Laboratory Biomarker Analysis
- First posted
- 2018-04-17
- Last updated
- 2025-09-09
- Results first posted
- 2025-02-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess Efficacy by Confirmed Overall Hematologic Response | From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years | 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. |
| Secondary | To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | Overall Survival (24 Month Estimate) | From date of enrollment up to 2 years | 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). |
| Secondary | Duration of Response (24 Month Estimate) | Up to 2 years | 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) |
| Secondary | Time to Hematologic Response | From registration to time of confirmed hematologic progression | 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. |
| Secondary | Progression-free Survival (24 Month Estimate) | From registration to time of confirmed hematologic progression | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess Efficacy by Confirmed Overall Hematologic Response | From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years | 35 participants who received treatment and are analyzable. | percentage of paticipants | NUMBER |
| SECONDARY | To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years | Participants who completed at least one day of treatment. | Participants | NUMBER |
| SECONDARY | Overall Survival (24 Month Estimate) | From date of enrollment up to 2 years | 35 eligible participants who received at least one dose of study drug. | percent of participants | NUMBER |
| SECONDARY | Duration of Response (24 Month Estimate) | Up to 2 years | 27 participants with response to study treatment | Percent of Participants | NUMBER |
| SECONDARY | Time to Hematologic Response | From registration to time of confirmed hematologic progression | Of the 35 analyzable participants, 27 achieved a response. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (24 Month Estimate) | From registration to time of confirmed hematologic progression | 35 participants were analyzable | percentage of paticipants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assess Efficacy by Confirmed Overall Hematologic Response | Isatuximab | 77.1 | 95% Confidence Interval 59.9 to 89.6 | percentage of paticipants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Atrial fibrillation | 1 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Fatigue | 1 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Infections and infestations - Other, specify | 1 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Infusion related reaction | 1 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Lung infection | 2 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Lymphocyte count decreased | 3 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Pancreatitis | 1 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Pruritus | 1 | Participants | |
| To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab. | Isatuximab | Skin infection | 1 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Isatuximab) | 43 | |
| Overall Study | COMPLETED | Treatment (Isatuximab) | 19 | |
| Overall Study | NOT COMPLETED | Treatment (Isatuximab) | 24 |
Source ClinicalTrials.gov
Adverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Isatuximab | 10 | 35 | |
| other | Blood and lymphatic system disorders-Other | Blood and lymphatic system disorders | Isatuximab | 2 | 35 | |
| other | Cardiac disorders-Other | Cardiac disorders | Isatuximab | 3 | 35 | |
| other | Heart failure | Cardiac disorders | Isatuximab | 2 | 35 | |
| other | Palpitations | Cardiac disorders | Isatuximab | 4 | 35 | |
| other | Sinus tachycardia | Cardiac disorders | Isatuximab | 2 | 35 | |
| other | Ear pain | Ear and labyrinth disorders | Isatuximab | 2 | 35 | |
| other | Hypothyroidism | Endocrine disorders | Isatuximab | 2 | 35 | |
| other | Blurred vision | Eye disorders | Isatuximab | 3 | 35 | |
| other | Cataract | Eye disorders | Isatuximab | 3 | 35 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isatuximab | 1 | 35 |
| Total, other adverse events | Isatuximab | 32 | 35 |
| Total, serious adverse events | Isatuximab | 15 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40925099 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03499808
GET https://conductscience.org/api/trials/v1/NCT03499808/events?page=2