This page shows what was measured, who it was measured in, and what that does not settle.
What Isatuximab does in the body
Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells.
From the FDA-approved label: Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab-irfc induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). Isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38. Isatuximab-irfc can activate natural killer (NK) cells in the absence of CD38-positive target tumor cells and suppresses CD38-positive T-regulatory cells.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · R30772KCU0 · read 2026-08-29
Where each sentence above came from
What the label states this substance does, quoted from it. No plain-language version of this sentence has been written.
No recorded use is stored in reader language.
No statement of the main limit is recorded.
The four opening statements run to 117 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Overall survival
✗ The study did not show it
Who was studied
NCT06860269
How many people
1200
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Negative MRD rate
✗ The study did not show it
Who was studied
NCT04934475
How many people
791
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
✗ The study did not show it
Who was studied
NCT07764978
How many people
750
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
MRD negativity after induction Treatment (comparison of arms IA and IB)
✗ The study did not show it
Who was studied
NCT03617731
How many people
662
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Progression-Free Survival
✗ The study did not show it
Who was studied
NCT06182774
How many people
570
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. 2 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
laboratory abnormalities liver function parameters
Meaningful
Things that change how a life goes, not only a number.
progression free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (38)
phase 1 number of dose limiting toxicities
phase 1 number of treatment emergent adverse events
dose limiting toxicities
arm i incidence of dose limiting toxicities
arm ii overall response rate
assessment of dose limiting toxicities in vcdi cohort
overall response rate
complete response rate
part a dose limiting toxicities
part b overall response rate
phase 2 percentage of overall response
overall response
mrd negativity
phase 2 percentage of overall response rate
laboratory abnormalities hematological parameters
laboratory abnormalities electrolytes
laboratory abnormalities renal parameters
overall response rate percentage of overall response
phase 1a number of adverse events by severity
phase 1a number of aes by frequency
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of SARCLISA ESCENA in pediatric patients have not been established.”
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-30
On older people, the label states: “Of the total number of patients in IRAKLIA, IZALCO, and IsaSoCut clinical studies of SARCLISA ESCENA (N=411), 38% (156 patients) were less than 65, 40% (166 patients) were 65–74, and 22% (89 patients) were 75 and over.”
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] , SARCLISA ESCENA can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of isatuximab-irfc in human milk or the effects on the breastfed child or milk production.”
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Still being tested
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Intravenous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4, S5.
No source is stored against this line.
What is in the pack
Sold as injection, solution, concentrate, injection, solution, given by the intravenous, subcutaneous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Isatuximab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 312 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
infusion related reaction — 74 reaction mentions
neutropenia — 57 reaction mentions
pneumonia — 48 reaction mentions
febrile neutropenia — 36 reaction mentions
acute kidney injury — 25 reaction mentions
plasma cell myeloma — 20 reaction mentions
covid-19 — 19 reaction mentions
febrile bone marrow aplasia — 12 reaction mentions
lymphopenia — 11 reaction mentions
covid-19 pneumonia — 10 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Intravenous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 0024-0656 · read 2026-08-29
They are sold as injection, solution, injection, solution, concentrate and liquid, taken intravenous and subcutaneous.
FDA National Drug Code directory · 0024-0656 · read 2026-08-29
The regulator's established pharmacologic class for it is antibodies, cd38-directed antibody interactions [moa] and cd38-directed cytolytic antibody [epc].
FDA National Drug Code directory · 0024-0656 · read 2026-08-29
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-29
Sarclisa Escena is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS SARCLISA ESCENA is a clear to slightly opalescent, colorless to slightly yellow solution, that may contain a few translucent to white particles, available as: Injection: 1,400 mg/10 mL (140…, recorded as fda label in effect 2026-07-10 in the United States.
US prescribing information · 07730e8c-1340-4d30-8d71-e20f850db8da · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Isatuximab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Isatuximab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
R30772KCU0
RxNorm concept
2282023
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4, S5.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
The earliest marketing start date recorded for a listed product is 20200302.
FDA National Drug Code directory · 0024-0656 · read 2026-08-29
What is missing or unclear◇Read from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (9)
Q2
What did Isatuximab's largest trial (791 people) and its longest (13 years) measure?
791 people in Isatuximab's largest registered study, 13 years in its longest registered window, measuring Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]. ClinicalTrials.gov · 2026-09-01
60 phase2, 30 phase1, 16 phase3, 2 na or unstated, 1 early phase1; NCT04270409; 2033-10-21. Last human test completed 2026, NCT06203912.
Interpretation These counts include studies where Isatuximab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
60
phase1
30
phase3
16
na or unstated
2
early phase1
1
Last recorded human testNCT06203912
2026-06-16
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Isatuximab shown healthspan?
Interpretation Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib] — the recorded outcome words.
Show the evidence
mouse
mechanism-only
humanNCT07601100
healthspan; Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]; 90
recorded 2026-09-01 · last checked 2026-09-04
Q4
12 of Isatuximab's trials stopped: safety, futility/efficacy, accrual/recruitment, other?
safety (4), futility/efficacy (2), accrual/recruitment (4) and other (2): Isatuximab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"The study was stopped after interim analysis indicated that overall result was not sufficient to satisfy per-protocol criteria to move forward in metastatic, castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer (NSCLC) cohorts."; 12 of 90 registered studies
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Trial
NCT03367819
terminated; "The study was stopped after interim analysis indicated that overall result was not sufficient to satisfy per-protocol criteria to move forward in metastatic, castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer…"
NCT03530683
terminated; "A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational…"
NCT03555149
terminated; "The Sponsor made the decision to terminate the study due to start up and recruitment issues caused by limited resource availability at the treating centers."
NCT03637764
terminated; "Study was stopped after interim analysis for 4 cohorts (HCC, SCCHN, EOC, and GBM) indicated that the results did not fulfill the preplanned interim analysis criteria to move to Phase 2 stage 2 in all 4 cohorts."
NCT03769181
terminated; "Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern"
NCT03860844
terminated; "Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns."
6 further recorded trials
NCT04083898
terminated; "Decision made to not move forward with Phase II portion of trial"
NCT04294459
terminated; "Terminated due to non-safety reasons"
NCT04802031
withdrawn; "Low accrual"
NCT04912427
terminated; "Low accrual"
NCT04943302
withdrawn; "PI left institution. Study not moving forward in her absence."
NCT05862766
withdrawn; "Study no longer had funding and therefore was closed before enrollment began."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which of abnormal electrolyte parameters, arm i incidence of dose limiting toxicities and arm ii overall response rate did Isatuximab's trials measure?
abnormal electrolyte parameters, arm i incidence of dose limiting toxicities and arm ii overall response rate lead 40 outcome terms across Isatuximab's trials. ClinicalTrials.gov · 2026-09-01
Interpretation arm i incidence of dose limiting toxicities, arm ii overall response rate, assessment of dose limiting toxicities in vcdi cohort, overall response rate, complete response rate and part a dose limiting toxicities follow.
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phase 1 number of dose limiting toxicities
1
phase 1 number of treatment emergent adverse events
1
dose limiting toxicities
1
arm i incidence of dose limiting toxicities
1
arm ii overall response rate
1
assessment of dose limiting toxicities in vcdi cohort
1
14 more recorded rows
overall response rate
1
complete response rate
1
part a dose limiting toxicities
1
part b overall response rate
1
phase 2 percentage of overall response
1
overall response
1
progression free survival
1
mrd negativity
1
phase 2 percentage of overall response rate
1
laboratory abnormalities hematological parameters
1
laboratory abnormalities electrolytes
1
laboratory abnormalities renal parameters
1
laboratory abnormalities liver function parameters
1
overall response rate percentage of overall response
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of Isatuximab's 56 ongoing trials reports first?
"Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)"; n 61; "Overall response (>= partial response)"; 2030-04-30
NCT03104842
"Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone"; n 246; "MRD negativity"; 2026-09
NCT03319667
"A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant"; n 475; "Progression free survival (PFS)"; 2027-06-30
NCT03617731
"Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)"; n 662; "MRD negativity after induction Treatment (comparison of arms IA and IB)"; 2028-06
NCT03989414
"A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)"; n 424; "Recommended Dose"; 2026-11-30
NCT04126200
"Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)"; n 208; "Number of Participants Randomized Across Sub-studies"; 2027-03-11
14 further recorded trials
NCT04240054
"Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency"; n 41; "The number of subjects who achieve very good partial response."; 2030-12-01
NCT04270409
"Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma"; n 337; "Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part"; 2033-10-21
NCT04430894
"KRDI in Transplant-Eligible MM"; n 50; "Complete Response (CR + Stringent CR) Rate"; 2026-12-30
NCT04558931
"Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma"; n 62; "Overall response rate as the occurrence of very good partial response or better after maintenance start"; 2032-12-31
NCT04614558
"Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance"; n 12; "Overall Renal Response Rate"; 2027-02
NCT04643002
"Isatuximab in Combination With Novel Agents in RRMM - Master Protocol"; n 258; "Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab"; 2028-04-20
NCT04653246
"Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM"; n 52; "Very Good Partial Response (VGPR)"; 2029-01-13
NCT04751877
"Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years)."; n 270; "Minimal Residual Disease (MRD) rate at 10-5 at 18 months"; 2027-08-17
NCT04754945
"Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis"; n 11; "Event-free proportion"; 2028-07-24
NCT04786028
"A Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in ND-TEMM"; n 72; "Response rate (VGPR or better) defined by IMWG criteria"; 2027-06
NCT04835129
"Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma"; n 28; "The number of subjects in each status category of the International Myeloma Working Group (stringent complete response, complete response, very good partial response, partial response)."; 2027-06-01
NCT04850599
"Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma"; n 5; "Overall response rate (ORR)"; 2029-02-21
NCT04883242
"Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma"; n 30; "Overall response rate"; 2031-12-31
Which running trial of Isatuximab could settle lifespan?
NCT03319667 measures Progression free survival (PFS), reading out 2027-06-30.
3 open trials; n 475; "A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant"
Show the evidence
Trial
NCT03319667
"A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant"; n 475; "Progression free survival (PFS)"; 2027-06-30
NCT06182774
"Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma"; n 570; "Progression-Free Survival"; 2032-07-31
NCT07601100
"Phase 1b/2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma"; n 88; "Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]"; 2034-07-01
Q8
Which 6 trials of Isatuximab posted no result?
Posted no result
6 of 6 completed trials
Registrations
NCT02283775, NCT02514668, NCT01749969, NCT03733717, NCT02513186 and NCT04045795
Completion dates
oldest 2021-05-26; newest 2024-03-27
Show the evidence
Trial
NCT02283775
2021-05-26
NCT02514668
2021-12-02
NCT01749969
2023-06-20
NCT03733717
2023-08-25
NCT02513186
2024-01-22
NCT04045795
2024-03-27
Q9
At the median, Isatuximab's trials enrolled 61 people — anything larger?
Median enrolment
61
Largest enrolment
791
Registered trials counted
90
Q10
What do 312 spontaneous reports say about Isatuximab — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Isatuximab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 312 reaction mentions were counted: infusion related reaction 74; neutropenia 57; pneumonia 48; febrile neutropenia 36. open-targets-adr · CHEMBL3545131 · 2026-06-24
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infusion related reaction
74
neutropenia
57
pneumonia
48
febrile neutropenia
36
acute kidney injury
25
plasma cell myeloma
20
4 more recorded rows
covid-19
19
febrile bone marrow aplasia
12
lymphopenia
11
covid-19 pneumonia
10
recorded 2026-06-24 · last checked 2026-09-04
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ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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