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CompletedNCT03499808Updated Sep 9, 2025Results posted

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

A Phase 2 interventional study of Isatuximab and Laboratory Biomarker Analysis in Amorphous, Eosinophilic, and Acellular Deposit, Constipation and Diarrhea, sponsored by SWOG Cancer Research Network. Completed at 345 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response or better) of isatuximab in relapsed/refractory systemic light chain (AL) amyloidosis.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in the treatment of relapsed/refractory AL amyloidosis with isatuximab.

II. To evaluate time to hematologic response. III. To evaluate duration of response. IV. To evaluate progression-free survival (PFS). V. To evaluate overall survival (OS).

TERTIARY OBJECTIVES:

I. To evaluate efficacy of isatuximab in relapsed/refractory immunoglobulin amyloid light chain (AL) amyloidosis as measured by organ specific response rates (cardiac, renal, gastrointestinal [GI], liver, soft tissue, nerve), in the subset of patients that can be evaluated for organ response.

II. To evaluate time to organ response in the subset of patients that can be evaluated for organ response.

OUTLINE:

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.

After completion of study treatment, patients are followed up within 30 days and then every at least every 6 months for up to 4 years.

02

Conditions studied

  • 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
03

In context

Constipation

1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.

This study's enrollment of 43 is below the median of 75 across 884 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse SWOG Cancer Research Network studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patient must have primary systemic AL amyloidosis, -confirmed by positive Congo red stain with green by birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence)
  • Patient must have within 28 days prior to registration; serum beta2 microglobulin, serum quantitative immunoglobulins (immunoglobulin [Ig]G, IgA, and IgM), serum free kappa and lambda, and serum protein electrophoresis (SPEP) with M-protein quantification must be obtained within 14 days prior to registration
  • Patient must demonstrate a difference in the involved serum free light chains (kappa or lambda) versus the uninvolved serum free light chain of >= 4.5 mg/dL within 14 days prior to registration

  • Patient must have objective organ involvement defined by ONE (or more) of the following; all disease for involved organs must be assessed and documented on the AL baseline tumor assessment form

    • Kidney: albuminuria greater than or equal to 500 mg per day on a 24-hour urine specimen within 35 days prior to registration, OR prior kidney (at time of diagnosis) showing amyloid deposition
    • Heart: mean left ventricular wall thickness on echocardiogram greater than or equal to 12 mm in the absence of hypertension or valvular heart disease, OR N-terminal fragment brain natriuretic protein (NT-pro) brain natriuretic peptide (BNP) greater than 332 ng/mL provided that patient does not have impaired renal function (as defined by calculated less than 25 mL/min) within 14 days prior to registration, OR prior cardiac biopsy (at time of diagnosis) showing amyloid deposition with past documented or presently noted clinical symptoms and signs supportive of a diagnosis of heart failure in the absence of an alternative explanation for heart failure
    • Liver: hepatomegaly (total liver span > 15 cm) as demonstrated by computed tomography (CT) or magnetic resonance imaging (MRI) within 35 days prior to registration OR elevated alkaline phosphatase (ALP) greater than 1.5 times the within 14 days prior to registration, OR prior liver biopsy (at time of diagnosis) showing amyloid deposition
    • Gastrointestinal tract: prior biopsy showing amyloid deposition AND symptoms such as GI bleeding or persistent diarrhea (> 4 loose stools/day on most days over a consecutive 28-day period)
    • Autonomic or peripheral nervous system: orthostatic blood pressure, symptoms of nausea, early satiety, diarrhea or constipation, abnormal sensory and/or motor findings on neurologic exam, or gastric atony by gastric emptying scan; Note: pulse and blood pressure must be recorded with the patient supine (lying down), and then again after at least 1 minute, but less than 3 minutes of standing; this assessment must be repeated on 2 separate occasions (at least 1 day apart; e.g. day -3 and day -1) within a 28-day screening period
    • Soft tissue: macroglossia, or soft tissue deposits (including lymphadenopathy, recurrent peri-orbital purpura, peri-articular, skin or other soft tissue) requiring therapy
  • Patients must not have active symptomatic multiple myeloma, as defined by 2015 International Myeloma Working Group (IMWG) criteria (hypercalcemia, renal failure, anemia, and bone [CRAB] criteria; bone marrow plasmacytosis > 60%); kappa: lambda ratio > 100 is acceptable only if the clinical symptoms and sign are attributable only to amyloidosis and not multiple myeloma ( [Hgb] \< 8 g/dL)
  • Patient must be relapsed or refractory to at least one (such as: transplant, radiation, or chemotherapy)
  • Patients must have completed other systemic therapy >= 14 days or drug >= 28 days prior to registration, surgery (other than biopsies) >= 21 days prior to registration, and any stem cell transplant (ASCT) >= 100 days prior to registration
  • Patients must not have received any or supplements which have been known to have some anti-amyloidogenic effect (such as: doxycycline; curcumin; prednisone; dexamethasone; epigallocatechin gallate [EGCG]) within 14 days prior to registration
  • Patients must not have any known allergies to isatuximab or other monoclonal antibody therapies
  • Patients must not have received daratumumab within 56 days prior to registration nor have been refractory to daratumumab
  • Patients must not be eligible for autologous stem cell transplantation
  • Patients must have a complete medical history and physical exam within 14 days prior to registration
  • Within 14 days prior to registration: Total =\< 2.0 x IULN (institutional upper limit of the norm) AND
  • Within 14 days prior to registration: Serum glutamic-oxaloacetic transaminase ()/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =\< 4.0 x IULN
  • Creatinine clearance (CrCl) >= 25 mL/min, as measured by a 24-hour urine collection or as estimated by the Cockcroft and Gault formula; the serum creatinine value used in the calculation must have been obtained within 35 days prior to registration
  • Patients must have bone marrow aspirate, including fluorescence in situ hybridization (FISH) (including: del 17p; t11;14; t4;14, t14;16; and del 13q) and cytogenetic testing (normal ? XY; and all abnormalities) within 35 days prior to registration; central pathology analysis will not be required, however the local pathology report and FISH/cytogenetic data must be submitted in Medidata RAVE
  • Within 14 days prior to registration: (ANC) >= 1,000 cells/mcl without growth factor support, AND
  • Within 14 days prior to registration: >= 75,000 cells/mcl
  • Patients must have hemoglobin >= 8 g/dL within 14 days prior to registration; patients may have received transfusion if greater than 7 days prior to registration
  • (NYHA) \< class IV heart failure
  • (LVEF) by echocardiogram (ECHO) >= 35% within 35 days prior to registration; and
  • NT-proBNP =\< 8500 ng/L within 14 days prior to registration
  • Patients must have a Zubrod performance status =\< 2

  • Patients must not have any uncontrolled systemic illness, including but not limited to uncontrolled, active infection requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus

    • Uncontrolled diabetes: patients who have a diagnosis of diabetes must have an glycosylated hemoglobin () \< 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
    • Uncontrolled blood pressure and hypertension: all blood pressure measurements within the 14 days prior to registration must be systolic blood pressure (SBP) =\< 160 and diastolic blood pressure (DBP) =\< 100; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure
  • Females of must have a negative baseline pregnancy test within 14 days prior to registration; this may be either a serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL; females of childbearing potential (FCBP) must also agree: (1) to have a pregnancy test prior to the start of each treatment cycle and (2) to either commit to continued abstinence from heterosexual intercourse or to use effective while receiving study drug and for at least 12 weeks after receiving the last dose of study drug; females are considered to be of ?childbearing potential? if they have had menses at any time in the preceding 24 consecutive months; in addition to routine contraceptive methods, ?effective contraception? also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures
  • Patients with evidence of virus (HBV) are eligible provided there is minimal hepatic injury and the patient has undetectable HBV on suppressive HBV therapy; patient must be willing to maintain adherence to HBV therapy; patients with previously treated and eradicated virus (HCV) who have minimal hepatic injury are eligible

  • Patients who are known to be (HIV)-positive at registration are eligible if at time of registration they meet all other protocol eligibility criteria in addition to the following:

    • Patient has undetectable HIV viral load by standard polymerase chain reaction (PCR) clinical assay
    • Patient is willing to maintain adherence to combination antiretroviral therapy
    • Patient has no history of acquired immunodeficiency syndrome (AIDS) defining condition (other than \< 200 mm\^3)
    • Patient is otherwise likely to have a near normal lifespan if not for the presence of relapsed/refractory amyloid
  • No other prior is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years
Terms in these criteria, in plain language(25)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Treatment (isatuximab)

    Patients receive isatuximab 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.

    Biological: Isatuximab · Other: Laboratory Biomarker Analysis

Interventions

  • BiologicalIsatuximab

    Given IV

    Also known as: Hu 38SB19, SAR 650984, SAR650984

  • OtherLaboratory Biomarker Analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Assess Efficacy by Confirmed Overall Hematologic Response

    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 frame: From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years

Secondary outcomes

  1. To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Time frame: From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years

  2. Overall Survival (24 Month Estimate)

    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 frame: From date of enrollment up to 2 years

  3. Duration of Response (24 Month Estimate)

    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 frame: Up to 2 years

  4. Time to Hematologic 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.

    Time frame: From registration to time of confirmed hematologic progression

  5. Progression-free Survival (24 Month Estimate)

    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 frame: From registration to time of confirmed hematologic progression

07

Results

Posted Feb 27, 2025

Participant flow

43 participants were enrolled of which 35 were eligible and analyzable.

Participant flow — Overall Study
MilestoneTreatment (Isatuximab)
Started43
Completed19
Not completed24

Outcome measures

PrimaryAssess Efficacy by Confirmed Overall Hematologic Response

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 frame:
From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years
Reported as:
Number · percentage of paticipants
Assess Efficacy by Confirmed Overall Hematologic Response
percentage of paticipantsIsatuximab
Assess Efficacy by Confirmed Overall Hematologic Response77.1 (59.9 to 89.6)
SecondaryTo Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Time frame:
From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years
Reported as:
Number · Participants
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
ParticipantsIsatuximab
Atrial fibrillation1
Fatigue1
Infections and infestations - Other, specify1
Infusion related reaction1
Lung infection2
Lymphocyte count decreased3
Pancreatitis1
Pruritus1
Skin infection1
Syncope1
SecondaryOverall Survival (24 Month Estimate)

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 frame:
From date of enrollment up to 2 years
Reported as:
Number · percent of participants
Overall Survival (24 Month Estimate)
percent of participantsIsatuximab
Overall Survival (24 Month Estimate)85 (73 to 97)
SecondaryDuration of Response (24 Month Estimate)

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 frame:
Up to 2 years
Reported as:
Number · Percent of Participants
Duration of Response (24 Month Estimate)
Percent of ParticipantsIsatuximab
Duration of Response (24 Month Estimate)81 (67 to 96)
SecondaryTime to Hematologic 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.

Time frame:
From registration to time of confirmed hematologic progression
Reported as:
Median · Months
Time to Hematologic Response
MonthsIsatuximab
Time to Hematologic Response1.1 (1 to 3)
SecondaryProgression-free Survival (24 Month Estimate)

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 frame:
From registration to time of confirmed hematologic progression
Reported as:
Number · percentage of paticipants
Progression-free Survival (24 Month Estimate)
percentage of paticipantsIsatuximab
Progression-free Survival (24 Month Estimate)74 (59 to 88)

Adverse events

Collected over Up to 4 years after registration. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Isatuximab1/35 (2.9%)15/35 (42.9%)32/35 (91.4%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventIsatuximab
Lung infectionInfections and infestations3/35
HypokalemiaMetabolism and nutrition disorders3/35
Abdominal painGastrointestinal disorders2/35
Gastrointestinal disorders-OtherGastrointestinal disorders2/35
VomitingGastrointestinal disorders2/35
FeverGeneral disorders2/35
Infusion related reactionInjury, poisoning and procedural complications2/35
DyspneaRespiratory, thoracic and mediastinal disorders2/35
Atrial fibrillationCardiac disorders1/35
Atrioventricular block completeCardiac disorders1/35
Most frequent other events
Showing 10 of 102
Most frequent other events
EventIsatuximab
DiarrheaGastrointestinal disorders18/35
Upper respiratory infectionInfections and infestations16/35
Infusion related reactionInjury, poisoning and procedural complications15/35
AnemiaBlood and lymphatic system disorders10/35
FatigueGeneral disorders10/35
Lymphocyte count decreasedInvestigations10/35
ConstipationGastrointestinal disorders9/35
NauseaGastrointestinal disorders9/35
HyperglycemiaMetabolism and nutrition disorders9/35
HypokalemiaMetabolism and nutrition disorders9/35

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Treatment (Isatuximab)
Median70 (40.1 to 79.5)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Isatuximab)
Female16
Male19
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Isatuximab)
Hispanic or Latino1
Not Hispanic or Latino32
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Isatuximab)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American1
White29
More than one race0
Unknown or Not Reported4
Performance Status
Performance Status(Participants)Treatment (Isatuximab)
PS 08
PS 125
PS 22
Involved Light Chain
Involved Light Chain(Participants)Treatment (Isatuximab)
Kappa10
Lambda23
None1
Unknown1
IgG (mg/dL)
IgG (mg/dL)(mg/dL)Treatment (Isatuximab)
Median700 (141 to 1689)
Organ Involvement
Organ Involvement(Participants)Treatment (Isatuximab)
Single Organ Involvement18
Multiple Organ involvement17

8 further baseline measures are reported on the registry.

08

Study locations

345 sites
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska 98508, United States
  • Anchorage Radiation Therapy Center
    Anchorage, Alaska 99504, United States
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska 99508, United States
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska 99508, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Anchorage Oncology Centre
    Anchorage, Alaska 99508, United States
  • Katmai Oncology Group
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • CHI Saint Vincent Cancer Center Hot Springs
    Hot Springs, Arkansas 71913, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Fremont - Rideout Cancer Center
    Marysville, California 95901, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Rocky Mountain Cancer Centers-Aurora
    Aurora, Colorado 80012, United States
  • The Medical Center of Aurora
    Aurora, Colorado 80012, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado 80304, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado 80907, United States
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
  • National Jewish Health-Main Campus
    Denver, Colorado 80206, United States
  • The Women's Imaging Center
    Denver, Colorado 80209, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Midtown
    Denver, Colorado 80218, United States
  • SCL Health Saint Joseph Hospital
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Rose
    Denver, Colorado 80220, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Western Surgical Care
    Denver, Colorado 80220, United States
  • Mercy Medical Center
    Durango, Colorado 81301, United States
  • Southwest Oncology PC
    Durango, Colorado 81301, United States
  • Comprehensive Cancer Care and Research Institute of Colorado LLC
    Englewood, Colorado 80113, United States
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Mountain Blue Cancer Care Center
    Golden, Colorado 80401, United States
  • National Jewish Health-Western Hematology Oncology
    Golden, Colorado 80401, United States
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado 81501, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Good Samaritan Medical Center
    Lafayette, Colorado 80026, United States
  • Rocky Mountain Cancer Centers-Lakewood
    Lakewood, Colorado 80228, United States
  • Saint Anthony Hospital
    Lakewood, Colorado 80228, United States
  • Rocky Mountain Cancer Centers-Littleton
    Littleton, Colorado 80120, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Rocky Mountain Cancer Centers-Sky Ridge
    Lone Tree, Colorado 80124, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • Rocky Mountain Cancer Centers-Longmont
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Parker Adventist Hospital
    Parker, Colorado 80138, United States
  • Rocky Mountain Cancer Centers-Parker
    Parker, Colorado 80138, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • Rocky Mountain Cancer Centers - Pueblo
    Pueblo, Colorado 81008, United States
  • National Jewish Health-Northern Hematology Oncology
    Thornton, Colorado 80260, United States
  • Rocky Mountain Cancer Centers-Thornton
    Thornton, Colorado 80260, United States
  • SCL Health Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Smilow Cancer Hospital-Derby Care Center
    Derby, Connecticut 06418, United States
  • Smilow Cancer Hospital Care Center-Fairfield
    Fairfield, Connecticut 06824, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • Smilow Cancer Center/Yale-New Haven Hospital
    New Haven, Connecticut 06510, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Yale-New Haven Hospital North Haven Medical Center
    North Haven, Connecticut 06473, United States
  • Smilow Cancer Hospital-Orange Care Center
    Orange, Connecticut 06477, United States
  • Smilow Cancer Hospital-Torrington Care Center
    Torrington, Connecticut 06790, United States
  • Smilow Cancer Hospital Care Center-Trumbull
    Trumbull, Connecticut 06611, United States
  • Smilow Cancer Hospital-Waterbury Care Center
    Waterbury, Connecticut 06708, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Cleveland Clinic-Weston
    Weston, Florida 33331, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Luke's Mountain States Tumor Institute
    Boise, Idaho 83712, United States
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
  • Kootenai Medical Center
    Coeur d'Alene, Idaho 83814, United States
  • Walter Knox Memorial Hospital
    Emmett, Idaho 83617, United States
  • Saint Luke's Mountain States Tumor Institute - Fruitland
    Fruitland, Idaho 83619, United States
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
  • Saint Luke's Mountain States Tumor Institute - Meridian
    Meridian, Idaho 83642, United States
  • Saint Alphonsus Medical Center-Nampa
    Nampa, Idaho 83686, United States
  • Saint Luke's Mountain States Tumor Institute - Nampa
    Nampa, Idaho 83686, United States
  • Kootenai Cancer Center
    Post Falls, Idaho 83854, United States
  • Kootenai Cancer Clinic
    Sandpoint, Idaho 83864, United States
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
    Twin Falls, Idaho 83301, United States
  • Rush - Copley Medical Center
    Aurora, Illinois 60504, United States
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
  • Memorial Hospital of Carbondale
    Carbondale, Illinois 62902, United States
  • SIH Cancer Institute
    Carterville, Illinois 62918, United States
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
  • Carle on Vermilion
    Danville, Illinois 61832, United States
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois 62526, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
  • Western Illinois Cancer Treatment Center
    Galesburg, Illinois 61401, United States
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States

Showing the first 100 of 345 sites. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Parker TL, Rosenthal A, Sanchorawala V, Landau HJ, Campagnaro EL, Kapoor P, Neparidze N, Girnius S, Hagen P, Scott EC, Hoering A, Durie BGM, Orlowski RZ. Isatuximab for relapsed and/or refractory AL amyloidosis: results of a prospective phase 2 trial (SWOG S1702). Blood. 2025 Nov 20;146(21):2507-2516. doi: 10.1182/blood.2024027962. PubMed 40925099 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03499808
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Jun 6, 2018
Primary completion
Aug 30, 2023
Completion
Sep 19, 2023
Results posted
Feb 27, 2025
Last update
Sep 9, 2025

Study contacts

Emma Scott
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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