DrugEvidence

Drugs / Bortezomib

Bortezomib

Drug

Bortezomib is an anti-cancer proteasome inhibitor used primarily in multiple myeloma and mantle cell lymphoma. It is marketed under brand names including Velcade and administered by injection. The drug has been approved in the U.S. since 2003.

Trials
935
Recruiting
67
Completed
516
With results
315

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetActiveCompletedTerminatedWithdrawnUnknownAvailableNo longer availableTotal
Early Phase 1 23211 9
Phase 1 4161262954 175
Phase 1/2 8365420812 111
Phase 2 28330245762038 440
Phase 2/3 1112111 8
Phase 3 1852854829 124
Phase 4 2118137 23
Not applicable 1825 16
Unknown 3116513 29

Trials started per year

2021
9
2022
24
2023
20
2024
24
2025
8
2026
31

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Multiple Myeloma 469561885959422 452
Neoplasms, Plasma Cell 1141132101 69
Recurrence 816281221 67
Lymphoma, Mantle-Cell 19103421 66
Lymphoma 120832211 65
Lymphoma, Non-Hodgkin 1591711 43
Lymphoma, Follicular 137202 42
Precursor Cell Lymphoblastic Leukemia-Lymphoma 158131112 41
Leukemia, Myeloid, Acute 178911 36
Lymphoma, Large B-Cell, Diffuse 1451311 34

Most active sponsors

#SponsorTrialsPhase 3
1National Cancer Institute (NCI)915
2Millennium Pharmaceuticals, Inc.306
3M.D. Anderson Cancer Center270
4Janssen Research & Development, LLC2514
5Dana-Farber Cancer Institute231
6University of Arkansas207
7PETHEMA Foundation184
8Mayo Clinic150
9Memorial Sloan Kettering Cancer Center140
10GlaxoSmithKline125

Most studied interventions

#InterventionTrials
1Bortezomib935
2Dexamethasone362
3Lenalidomide145
4Cyclophosphamide130
5Calcium Dobesilate102
6Rituximab98
7daratumumab95
8Melphalan68
9Doxorubicin64
10Thalidomide48

Evidence

Results reported
61%315 of 516 completed
Published
16.9%87 of 516 completed
Primary endpoint met
35.9%23 of 64 analyses
Median months to report
17

Documents disclosed

Protocol available
92
Statistical analysis plan
89
PubMed citations
120

Trial profile

Median enrollment
40
Median duration
57months
Countries
68
Study sites
10851

Who is enrolled

Adults
913
Children
80
Older adults
891
Healthy volunteers
8

Median enrollment by phase

Early Phase 1
11
Phase 1
23
Phase 1/2
42
Phase 2
36
Phase 2/3
35
Phase 3
402
Phase 4
40
Not applicable
22
Unknown
100

Where trials run

United States
592
Spain
93
France
91
Germany
88
China
86
Canada
75
Italy
73
United Kingdom
64
Australia
58
South Korea
55

Busiest cities

#CityCountryTrials
1BostonUnited States131
2New YorkUnited States127
3HoustonUnited States95
4AtlantaUnited States87
5RochesterUnited States81
6MadridSpain74
7ChicagoUnited States73
8BarcelonaSpain69
9SalamancaSpain68
10SeattleUnited States65

Terminations

Terminated
139
Withdrawn
40
Stopped for recruitment
7.1%66 of 935 trials

Stated reasons

Other / unclear
71
Recruitment
66
Funding
19
Lack of efficacy
9
Regulatory
5
Business decision
4
Safety
4
COVID-19
1

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT07428369 Withdrawn Withdrawn Sponsor Decision 2038-05-21
NCT03617484 Withdrawn Withdrawn Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval. 2030-07-31
NCT06015750 Withdrawn Withdrawn Sponsor decision following FDA release from the PMR. 2030-03-13
NCT06348147 Withdrawn Withdrawn budget 2029-05-31
NCT05408026 Withdrawn Withdrawn Study withdrawn, trial therapy deemed no longer novel and there was a lack of site interest. 2026-02-28
NCT05895201 Withdrawn Withdrawn PI has left IU with no plan to initiate study at IU 2025-12-31
NCT04570631 Terminated Terminated Strategic considerations 2025-05-05
NCT04285268 Withdrawn Withdrawn This study was never submitted to the IRB for review and approval. No research subjects were enrolled. . 2024-09-30
NCT05556616 Terminated Terminated Due to strategic reasons (no safety concerns). 2024-06-04
NCT04892446 Terminated Terminated This study was terminated early due to the Sponsor's decision to discontinue development of the investigational drug and close the program. 2024-04-25

Trial records