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Bortezomib

  • Prescription medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Bortezomib does in the body

Inhibition of the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling cascades within the cell.

From the FDA-approved label: Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin­-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. This disruption of normal homeostatic mechanisms can lead to cell death. Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types in vitro .

Why people take it. The treatment of adult patients with multiple myeloma

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 chemical.

    FDA substance registry · 69G8BD63PP · read 2026-08-29

  • Its recorded molecular formula is C19H25BN4O4, weighing 384.24.

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

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.

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 peopleRead 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

The study did not show it

Who was studied
NCT03643276
How many people
5000
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, subcutaneous

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Overall survival

The study did not show it

Who was studied
NCT01554852
How many people
4420
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, subcutaneous

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Event-free survival

The study did not show it

Who was studied
NCT03390387
How many people
4000
Study design
Not applicable
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, subcutaneous

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

16 weeks clinical response

The study did not show it

Who was studied
NCT04817956
How many people
3000
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. Intravenous, subcutaneous

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

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. Intravenous, subcutaneous

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations

The study did not show it

Who was studied
NCT01371981
How many people
1645
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, subcutaneous

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
  • PubChem PUG-REST · 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 unclearRead 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.

  • Bortezomib for injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for injection, 3.5 mg/vial is indicated for the treatment of adult patients with multiple myeloma.

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 have not been established in pediatric patients.”

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-30

  • On older people, the label states: “Of the 669 patients enrolled in the relapsed multiple myeloma study, 245 (37%) were 65 years of age or older: 125 (38%) on the bortezomib arm and 120 (36%) on the dexamethasone arm.”

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · 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) ] and findings in animals, bortezomib can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of bortezomib or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production.”

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-30

  • On people with reduced liver function, the label states: “No starting dosage adjustment of bortezomib is recommended for patients with mild hepatic impairment (total bilirubin ≤1× ULN and AST >ULN, or total bilirubin >1 to 1.5× ULN and any AST).”

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No starting dosage adjustment of bortezomib is recommended for patients with renal impairment.”

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · 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 takeRead 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 takeRead 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

Intravenous, subcutaneous

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.

No source is stored against this line.

What is in the pack

Sold as injectable, solution, powder, injection, powder, lyophilized, for solution, given by the intravenous, subcutaneous, injection, intravenous 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 takeNothing 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 unclearRead 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, subcutaneous

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

  • 52 products list this as an active ingredient in the United States drug directory. 52 of them contain it and nothing else.

    FDA National Drug Code directory · 72338-200 · read 2026-08-29

  • They are sold as injection, injection, powder, lyophilized, for solution and powder, taken intravenous and subcutaneous.

    FDA National Drug Code directory · 72338-200 · read 2026-08-29

  • The regulator's established pharmacologic class for it is proteasome inhibitor [epc] and proteasome inhibitors [moa].

    FDA National Drug Code directory · 72338-200 · read 2026-08-29

  • 30 published labels name it as an active ingredient. 30 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · read 2026-08-29

  • 1 marketed supplement label lists this ingredient, classed as other combinations.

    NIH Dietary Supplement Label Database · 214980 · read 2026-08-29

  • Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 214980 · read 2026-08-29

  • bortezomib is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: Each single-dose vial of bortezomib for injection contains 3.5 mg of bortezomib as a sterile lyophilized white to off-white powder for reconstitution and withdrawal of the app…, recorded as fda label in effect 2021-11-22 in the United States.

    US prescribing information · 854be921-5fd9-482a-8432-a0c0241625f8 · 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 takeRead 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 Bortezomib 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 unclearRead 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 Bortezomib 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 peopleRead 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.

How many documents were read

  • 29 documents were read for this substance.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
69G8BD63PP
RxNorm concept
402243

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.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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

  • 30 approved applications cover products containing this substance. The earliest was NDA021602, approved 20030513 to TAKEDA PHARMS USA.

    Drugs@FDA application register · NDA021602 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA021602 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20030513.

    FDA National Drug Code directory · 72338-200 · read 2026-08-29

What is missing or unclearRead 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

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 (11)

On the Bortezomib label: indicated for what?


"Bortezomib for Injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma. ( 1.1 ) treatment of adult patients with mantle cell lymphoma.": indications and usage on Bortezomib's label. DailyMed label · decb5d94-2ea2-48d8-b08b-3196b24c0ed3 · 2026-01-09

830 registered trials of Bortezomib — at which phases?


Registered studies posting no result
534 of 830

830 registered studies of Bortezomib: 498 phase2, 256 phase1, 112 phase3, 25 na or unstated, 20 phase4, 15 na, 6 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1141 with a PubMed record

Show the evidence
  • phase2
    498
  • phase1
    256
  • phase3
    112
  • na or unstated
    25
  • phase4
    20
  • na
    15
9 more recorded rows
  • early phase1
    6
  • completed
    459
  • terminated
    126
  • active not recruiting
    69
  • unknown
    69
  • recruiting
    57
  • withdrawn
    35
  • not yet recruiting
    12
  • no longer available
    3

recorded 2026-09-01 · last checked 2026-09-04

141 of Bortezomib's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (7), futility/efficacy (6), accrual/recruitment (66), funding/business (20), sponsor decision unspecified (9) and other (33): Bortezomib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Administratively complete."; 141 of 830 registered studies

Show the evidence

Trial

  • NCT00006773
    terminated; "Administratively complete."
  • NCT00023881
    terminated; "Lack of efficacy"
  • NCT00040768
    terminated; "Administratively complete."
  • NCT00066625
    terminated; "Administratively complete."
  • NCT00085410
    terminated; "The trial was discontinued early due to no confirmed partial responses."
  • NCT00103376
    terminated; "Low Accrual"
14 further recorded trials
  • NCT00106262
    terminated; "Lack of accrual"
  • NCT00117351
    terminated; "insufficient efficacy"
  • NCT00124579
    terminated; "poor accrual"
  • NCT00128921
    terminated; "study terminated due to low accrual"
  • NCT00136591
    terminated; "An arm closed due to lack of efficacy"
  • NCT00183937
    terminated; "Sponsor stopped study early."
  • NCT00200382
    terminated; "The study did not achieve the statistical success to continue."
  • NCT00210392
    terminated; "After IELSG25A study amendment, patients subject of the present study were eligible for inclusion in the IELSG25A study"
  • NCT00265928
    terminated; "Withdrawn for poor accrual"
  • NCT00271804
    terminated; "New study with lenalidomide pending"
  • NCT00290706
    terminated; "Closed per Data Monitoring Committee due to lack of efficacy"
  • NCT00361088
    terminated; "Initial Principal Investigator left Moffitt"
  • NCT00361621
    terminated; "Closed due to slow accrual"
  • NCT00366106
    terminated; "Study was closed to enrollment when it became clear that enrollment was too slow to complete full enrollment target within time frame allowed."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Bortezomib used Bortezomib 1.0mg/m^2 — over how long?


studies of Bortezomib used the recorded amount. ClinicalTrials.gov · 2026-09-01

8 recorded entries; human; also "Bortezomib 1.0mg/m^2", "Bortezomib 1.3mg/m^2", "Bortezomib 1.3 mg/m2"

Show the evidence

human

  • NCT00410423
    Bortezomib 1.0mg/m^2
  • NCT00410423
    Bortezomib 1.3mg/m^2
  • NCT00424840
    Bortezomib 1.3 mg/m2
  • NCT00424840
    Bortezomib 1.6 mg/m2
  • NCT00424840
    Bortezomib 1.8 mg/m2
  • NCT00784823
    Bortezomib 1 mg/m2
2 more recorded rows
  • human NCT01633645
    VELCADE 1 mg/m2 on days 1 and 8, of a 21-days treatment cycle for a maximum of 8 cycles
  • human NCT04348006
    Bortezomib 3.5 MG

recorded 2026-09-01 · last checked 2026-09-04

Bortezomib's half-life is 40 to 193 hours — which schedules were studied?


40 to 193 hours, the half-life Bortezomib's label states: "Elimination The mean elimination half-life of bortezomib upon multiple dosing ranged from 40 to 193 hours after the 1 mg/m 2 dose and 76 to 108 hours after the 1.3 mg/m 2 dose." DailyMed label · decb5d94-2ea2-48d8-b08b-3196b24c0ed3 · 2026-01-09

Show the evidence
  • half life pharmacokinetics
    40 to 193 hours; Elimination The mean elimination half-life of bortezomib upon multiple dosing ranged from 40 to 193 hours after the 1 mg/m 2 dose and 76 to 108 hours after the 1.3 mg/m 2 dose.
  • metabolism pharmacokinetics
    Metabolism Bortezomib is primarily oxidatively metabolized to several inactive metabolites in vitro via cytochrome P450 (CYP) enzymes 3A4, CYP2C19, and CYP1A2, and to a lesser extent by CYP2D6 and CYP2C9.

recorded 2026-01-09 · last checked 2026-09-04

Which running trial of Bortezomib could settle lifespan?


NCT02112916 measures Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients, reading out 2026-09-16.

42 open trials; n 847; "Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma"

Show the evidence

Trial

  • NCT02112916
    "Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma"; n 847; "Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients"; 2026-09-16
  • NCT05248633
    "Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma"; n 220; "event-free survival"; 2026-10
  • NCT01208662
    "Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65"; n 729; "Median Progression-Free Survival (PFS)"; 2026-12
  • NCT03729804
    "Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA)"; n 250; "Number of Participants with progression free survival with the group taking KRd versus VRd after randomization"; 2026-12-28
  • NCT05736419
    "A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)"; n 24; "Number of participants with treatment related mortality/TRM or primary graft failure"; 2027-02-09
  • 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
14 further recorded trials
  • NCT00644228
    "Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma"; n 525; "Progression-free Survival"; 2027-06-10
  • 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
  • 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
  • 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
  • NCT06158841
    "Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma"; n 421; "Progression Free Survival (PFS)"; 2027-12
  • NCT06152575
    "MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)"; n 492; "Progression free survival per International Myeloma Working Group criteria"; 2027-12-30
  • NCT04566328
    "Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial"; n 1450; "Consolidation overall survival"; 2027-12-31
  • 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
  • NCT03643276
    "Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017"; n 5000; "Event-free survival"; 2028-07-14
  • NCT00734877
    "UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma"; n 382; "Progression-free survival rate"; 2028-09
  • 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

Which 202 trials of Bortezomib posted no result?


Posted no result
202 of 202 completed trials
Registrations
NCT00006098, NCT00006362, NCT00028639, NCT00027716, NCT00064012 and NCT00048230, and 196 more
Completion dates
oldest 2001-10; newest 2024-05-20
Show the evidence

Trial

  • NCT00006098
    2001-10
  • NCT00006362
    2003-08
  • NCT00028639
    2003-11
  • NCT00027716
    2004-05
  • NCT00064012
    2004-07
  • NCT00048230
    2004-12
14 further recorded trials
  • NCT00038571
    2005-03
  • NCT00063726
    2005-07
  • NCT00021216
    2005-12
  • NCT00093028
    2006-01
  • NCT00752518
    2006-01
  • NCT00025376
    2006-03
  • NCT00216697
    2006-10
  • NCT00193232
    2007-02
  • NCT00059618
    2007-04
  • NCT00017199
    2007-05
  • NCT00142129
    2007-06
  • NCT00217503
    2007-06
  • NCT00068289
    2007-07
  • NCT00083460
    2007-11

At the median, Bortezomib's trials enrolled 39 people — anything larger?


Median enrolment
39
Largest enrolment
5000
Registered trials counted
808

What do 11074 spontaneous reports say about Bortezomib — 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.

Bortezomib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11074 reaction mentions were counted: neuropathy peripheral 2710; plasma cell myeloma 2222; thrombocytopenia 1429; pneumonia 1133. FAERS via Open Targets · CHEMBL325041 · 2026-06-24

Show the evidence
  • neuropathy peripheral
    2710
  • plasma cell myeloma
    2222
  • thrombocytopenia
    1429
  • pneumonia
    1133
  • neutropenia
    913
  • platelet count decreased
    751
4 more recorded rows
  • disease progression
    683
  • febrile neutropenia
    553
  • polyneuropathy
    384
  • plasma cell myeloma recurrent
    296

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Bortezomib's label not list?


disease progression, febrile neutropenia and neuropathy peripheral and 7 more reported for Bortezomib, absent from its label. FAERS via Open Targets · CHEMBL325041 · 2026-06-24

2 label terms; 10 reported and unlisted; decb5d94-2ea2-48d8-b08b-3196b24c0ed3

Show the evidence
  • disease progression
    count not stated
  • febrile neutropenia
    count not stated
  • neuropathy peripheral
    count not stated
  • neutropenia
    count not stated
  • plasma cell myeloma
    count not stated
  • plasma cell myeloma recurrent
    count not stated
4 more recorded rows
  • platelet count decreased
    count not stated
  • pneumonia
    count not stated
  • polyneuropathy
    count not stated
  • thrombocytopenia
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Bortezomib and CYP3A4, CYP1A2 and CYP2C9: shared by which compounds?


CYP3A4, CYP1A2 and CYP2C9 appear in Bortezomib's recorded interaction sentences, 8 in all. DailyMed label · decb5d94-2ea2-48d8-b08b-3196b24c0ed3 · 2026-01-09

CYP1A2, CYP2C19, CYP2C19, CYP2C9, CYP2D6, CYP3A4; 7 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use.
  • drug_interactions
    ( 7.1 ) Strong CYP3A4 Inducers: Avoid concomitant use.
  • drug_interactions
    ( 7.1 ) 7.1 Effects of Other Drugs on Bortezomib for Injection Strong CYP3A4 Inducers Coadministration with a strong CYP3A4 inducer decreases the exposure of bortezomib [see Clinical Pharmacology ( 12.3 )] which may decrease Bortezomib for Injection efficacy.
  • drug_interactions
    Avoid coadministration with strong CYP3A4 inducers.
  • drug_interactions
    Strong CYP3A4 Inhibitors Coadministration with a strong CYP3A4 inhibitor increases the exposure of bortezomib [see Clinical Pharmacology ( 12.3 )] which may increase the risk of bortezomib toxicities.
  • drug_interactions
    Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors.
2 more recorded rows
  • Interaction statement pharmacokinetics
    Metabolism Bortezomib is primarily oxidatively metabolized to several inactive metabolites in vitro via cytochrome P450 (CYP) enzymes 3A4, CYP2C19, and CYP1A2, and to a lesser extent by CYP2D6 and CYP2C9.
  • Interaction statement pharmacokinetics
    Drug Interaction Studies Clinical Studies No clinically significant differences in bortezomib pharmacokinetics were observed when coadministered with dexamethasone (weak CYP3A4 inducer), omeprazole (strong CYP2C19 inhibitor), or melphalan in combination with prednisone.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole

CYP2C19

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-01-09 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL325041
PubChem CID
59476170
CAS number
1132709-15-9
RxCUI
402243
InChIKey
GXJABQQUPOEUTA-RDJZCZTQSA-N
Salt form
Bortezomib hydrate
Development code
LDP-341, NSC-681239, PS-341
Also called
alvocade, bort, btz, jnj-26866138, pad, ps341, vel, vrd, BORONIC ACID, ((1R)-3-METHYL-1-(((2S)-1-OXO-3-PHENYL-2-((PYRAZINYLCARBONYL)AMINO)PROPYL)AMINO)BUTYL)-, BORTEZOMIB HYDRATE [JAN], BORTEZOMIB [EMA EPAR], BORTEZOMIB [HSDB]
Trade name
Velcade, Boruzu, Velcade / Boruzu, BORTEZOMIB ACCORD, Bortezomib Hospira, Bortezomib Sun, Bortezomib Fresenius Kabi
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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.