This page shows what was measured, who it was measured in, and what that does not settle.
What Daratumumab does in the body
The treatment of adult patients with multiple myeloma
From the FDA-approved label: CD38 is a transmembrane glycoprotein (48 kDa) expressed on the surface of hematopoietic cells, including multiple myeloma and other cell types and tissues and has multiple functions, such as receptor mediated adhesion, signaling, and modulation of cyclase and hydrolase activity. Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to CD38 and inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP).
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 · 4Z63YK6E0E · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 120 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
Event-free survival (EFS) in patients with newly diagnosed T-cell lymphoblastic leukemia (T-ALL)
✗ The study did not show it
Who was studied
NCT07072585
How many people
1708
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
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 (PFS)
✗ The study did not show it
Who was studied
NCT05552222
How many people
1590
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
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
Incidence of Adverse Events (AEs)
✗ The study did not show it
Who was studied
NCT03899155
How many people
1500
Study design
Phase 2
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
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
Consolidation overall survival
✗ The study did not show it
Who was studied
NCT04566328
How many people
1450
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
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
iFIT1: Progression-free survival (PFS)
✗ The study did not show it
Who was studied
NCT07649525
How many people
1226
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
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
Part 1 Dose Limiting Toxicity
✗ The study did not show it
Who was studied
NCT05623020
How many people
1116
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
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 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.
DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
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: “Safety and effectiveness of DARZALEX in pediatric patients have not been established.”
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · read 2026-08-30
On older people, the label states: “Of the 2,459 patients who received DARZALEX at the recommended dose, 38% were 65 to 74 years of age, and 15% were 75 years of age and older.”
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary DARZALEX can cause fetal harm when administered to a pregnant woman.”
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no data on the presence of daratumumab in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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
Given by a clinician
❝ 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
Injection
✎ 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 injectable, injection, solution, concentrate, injection, given by the injection, 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.
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
Injection
✎ 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. 4 of them contain it and nothing else.
FDA National Drug Code directory · 64406-520 · read 2026-08-29
They are sold as injection, injection, solution, concentrate and liquid, taken intravenous and subcutaneous.
FDA National Drug Code directory · 64406-520 · 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 · 64406-520 · read 2026-08-29
2 published labels name it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · read 2026-08-29
DARZALEX is intravenous at 3 DOSAGE FORMS AND STRENGTHS DARZALEX is a colorless to pale yellow, preservative-free solution available as: Injection: 100 mg/5 mL (20 mg/mL) in a single-dose vial. 400 mg/20 mL (20 mg/mL) in a single-dose vial., recorded as fda label in effect 2026-06-05 in the United States.
US prescribing information · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · 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 Daratumumab 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.
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 Daratumumab 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)
4Z63YK6E0E
RxNorm concept
1721951
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: Written into the record, not signed off.
✗ 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
1 approved application covers products containing this substance. The earliest was BLA761036, approved 20151116 to JANSSEN BIOTECH.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 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.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — 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 (10)
Q2
On the Daratumumab label: indicated for what?
"DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior…": indications and usage on Daratumumab's label. DailyMed label · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · 2026-06-05
Q3
292 registered trials of Daratumumab — at which phases?
Registered studies posting no result
224 of 292
292 registered studies of Daratumumab: 175 phase2, 80 phase1, 57 phase3, 8 na or unstated, 6 na, 5 phase4, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"DLBCL and FL cohorts met the pre-specified futility criteria and will not proceed. The MCL cohort was terminated due to slow recruitment and aggressive disease."; 41 of 292 registered studies
Show the evidence
Trial
NCT02413489
terminated; "DLBCL and FL cohorts met the pre-specified futility criteria and will not proceed. The MCL cohort was terminated due to slow recruitment and aggressive disease."
NCT02807454
terminated; "Health Authority request due to class effect"
NCT03035357
withdrawn; "PI's Request"
NCT03067571
terminated; "Study terminated early because of lack of efficacy"
terminated; "The sponsor decided to terminate the study following an FDA request of a partial clinical hold."
NCT03537599
terminated; "Poor acccrual"
NCT03591744
withdrawn; "Budgetary constraints"
NCT03622775
terminated; "\<75% participation"
NCT03679624
terminated; "Low accrual"
NCT03701321
withdrawn; "Drug supply issues"
NCT03841565
withdrawn; "There are no patients enrolled on this study and all efforts are being discontinued."
NCT04024384
withdrawn; "Promotor decision"
NCT04088903
withdrawn; "Protocol changed to use subcutaneous rather than intravenous daratumumab."
NCT04205240
terminated; "Poor accrual"
NCT04223661
withdrawn; "lack of funding"
NCT04230031
withdrawn; "Difficult enrollment due to changes in standard of care"
NCT04230304
terminated; "Slow accrual"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Daratumumab used Daratumumab 16 mg/kg (Part 1) — over how long?
studies of Daratumumab used the recorded amount. ClinicalTrials.gov · 2026-09-01
6 recorded entries; human; also "Daratumumab 16 mg/kg (Part 1)", "Daratumumab 8 mg/kg (Part 1)", "Daratumumab - 16mg/kg"
Show the evidence
human
NCT01985126
Daratumumab 16 mg/kg (Part 1)
NCT01985126
Daratumumab 8 mg/kg (Part 1)
NCT02773030
Daratumumab - 16mg/kg
NCT02773030
Daratumumab- 1800mg
NCT02918331
Daratumumab (16 mg/kg)
NCT03697655
Daratumumab 20 MG/ML [Darzalex]
recorded 2026-09-01 · last checked 2026-09-04
Q6
Daratumumab's half-life is 18 ± 9 days — which schedules were studied?
18 ± 9 days, the half-life Daratumumab's label states: "The mean ± SD linear clearance was estimated to be 171.4 ± 95.3 mL/day and the mean ± SD estimated terminal half-life associated with linear clearance was 18 ± 9 days following administration of the approved recommended dosage of DARZALEX as monotherapy." DailyMed label · a4d0efe9-5e54-467e-9eb4-56fa7d53b60b · 2026-06-05
Show the evidence
half lifepharmacokinetics
18 ± 9 days; The mean ± SD linear clearance was estimated to be 171.4 ± 95.3 mL/day and the mean ± SD estimated terminal half-life associated with linear clearance was 18 ± 9 days following administration of the approved recommended dosage of DARZALEX as monotherapy.
recorded 2026-06-05 · last checked 2026-09-04
Q7
Which running trial of Daratumumab could settle lifespan?
NCT05898646 measures Event free survival, reading out 2026-11-30.
33 open trials; n 96; "Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial"
Show the evidence
Trial
NCT05898646
"Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial"; n 96; "Event free survival"; 2026-11-30
NCT04181827
"A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma"; n 419; "Progression Free Survival (PFS)"; 2027-03-31
NCT03346135
"Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma"; n 31; "Progression-free survival"; 2027-05-17
NCT04009109
"Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM"; n 79; "Impact of Study Treatment on Progression Free Survival (PFS)"; 2027-06
NCT07274462
"DARA-MVI Study (Daratumumab for Microvascular Inflammation in Kidney Transplantation)"; n 20; "Primary Outcome: Change in microvascular inflammation score (Banff g + ptc) between baseline and 12 months."; 2027-09-30
NCT03004287
"2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy"; n 50; "Measure the progression-free survival in patients with high risk multiple myeloma"; 2027-10
14 further recorded trials
NCT06140966
"Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma"; n 54; "2-year progression-free survival"; 2027-10-20
NCT03763162
"Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma"; n 40; "Progression free survival (PFS)"; 2027-10-30
NCT05455320
"A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment"; n 864; "Progression-Free Survival (PFS)"; 2028-05-25
NCT04246047
"Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma"; n 494; "Progression-free Survival (PFS)"; 2028-06-30
NCT06868654
"China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma"; n 72; "Progression-free Survival (PFS)"; 2028-06-30
NCT06868667
"Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma"; n 24; "Progression-free Survival (PFS)"; 2028-06-30
NCT05083169
"A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma"; n 587; "Progression Free Survival (PFS)"; 2028-09-15
NCT07638683
"A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)."; n 30; "1-Year Progression-Free Survival (PFS) Rate"; 2028-12-30
NCT03710603
"Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma"; n 709; "Progression Free Survival (PFS)"; 2029-11
NCT03937635
"Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma"; n 288; "Overall survival (OS)"; 2029-12-31
NCT03829371
"STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA"; n 450; "Progression-free survival (PFS)"; 2030-01-03
NCT07452198
"A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma"; n 358; "Progression Free Survival (PFS)"; 2030-03
NCT06464991
"A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)"; n 240; "Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC)"; 2030-12
NCT06413498
"A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma"; n 452; "Progression-Free Survival (PFS)"; 2031-07
Q8
Which 26 trials of Daratumumab posted no result?
Posted no result
26 of 26 completed trials
Registrations
NCT02116569, NCT02419118, NCT03068351, NCT03320707, NCT02852837 and NCT02918331, and 20 more
Completion dates
oldest 2015-09; newest 2024-07-10
Show the evidence
Trial
NCT02116569
2015-09
NCT02419118
2015-10-01
NCT03068351
2019-08-01
NCT03320707
2019-08-27
NCT02852837
2019-12-13
NCT02918331
2020-03
14 further recorded trials
NCT02626481
2020-03-09
NCT02816476
2020-10
NCT02431208
2021-03-19
NCT02977494
2021-06
NCT04065789
2021-11-12
NCT03697629
2021-12-20
NCT04280328
2022-03-01
NCT03215524
2022-06-24
NCT03768960
2022-07-16
NCT04136756
2023-04-24
NCT03311828
2023-06-05
NCT05974969
2023-08-15
NCT04121260
2023-10-13
NCT05306587
2024-01-01
Q9
At the median, Daratumumab's trials enrolled 49 people — anything larger?
Median enrolment
49
Largest enrolment
1708
Registered trials counted
290
Q10
What do 4011 spontaneous reports say about Daratumumab — 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.
Daratumumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4011 reaction mentions were counted: infusion related reaction 1201; pneumonia 518; plasma cell myeloma 408; neutropenia 394. FAERS via Open Targets · CHEMBL1743007 · 2026-06-24
Show the evidence
infusion related reaction
1201
pneumonia
518
plasma cell myeloma
408
neutropenia
394
thrombocytopenia
384
neuropathy peripheral
293
4 more recorded rows
platelet count decreased
226
disease progression
223
febrile neutropenia
202
neutrophil count decreased
162
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Daratumumab's label not list?
Daratumumab component of darzalex faspro, Darzalex IV, Darzalex / Darzalex IV, DARZALEX FASPRO COMPONENT DARATUMUMAB
Also called
Daratumumab-fihj, Darzalex, 89zr-dfo-daratumumab, dara, dara iv, dara sc, daratumumab and hyaluronidase-fihj, daratumumab sc, daratumumab-hyaluronidase, daratumumab/rhuph20, daravcd, darzalex faspro (daratumumab and hyaluronidase-fihj)
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.