Bortezomib

Generic Name: Bortezomib

Brand Names: Velcade, Bortezomib Accord, Bortezomib Hospira, Bortezomib Fresenius Kabi, Bortezomib Sun

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₅BN_₄O_₄

CAS Number: 179324-69-7

Unique Ingredient Identifier: 69G8BD63PP

Background: Bortezomib is a dipeptide boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. The 26S proteasome is a protein complex that degrades ubiquitinated proteins in the ubiquitin-proteasome pathway: reversible inhibition of the 26S proteasome, leading to cell cycle arrest and apoptosis of cancer cells, is thought to be the main mechanism of action of bortezomib. However, multiple mechanisms may be involved in the anticancer activity of bortezomib.

Bortezomib was first synthesized in 1995. In May 2003, bortezomib became the first anticancer proteasome inhibitor that was approved by the FDA under the trade name VELCADE. Phase I, II, III, and IV clinical trials are undergoing to investigate the therapeutic efficacy of bortezomib in leukemia, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, and solid tumours.

Indication: Bortezomib is indicated for the treatment of adults with multiple myeloma or mantle cell lymphoma.

Associated Conditions: Mantle Cell Lymphoma (MCL), Multiple Myeloma (MM)

Associated Therapies: -

Clinical Trials

Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Bortezomib

First Posted Date: 2011-03-15

Last Posted Date: 2018-02-07

Lead Sponsor: NYU Langone Health

Target Recruit Count: 24

Registration Number: NCT01315873

Locations: 🇺🇸
New York University Langone Medical Center, New York, New York, United States

UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib

First Posted Date: 2011-03-14

Last Posted Date: 2017-05-19

Lead Sponsor: University of Arkansas

Target Recruit Count: 10

Registration Number: NCT01313897

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Phase 2

Terminated

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Bortezomib
Drug: Vorinostat
Drug: Dexamethasone
Drug: Methotrexate
Drug: Imatinib mesylate

First Posted Date: 2011-03-11

Last Posted Date: 2017-12-28

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 2

Registration Number: NCT01312818

Locations: 🇺🇸
Masonic Cancer Center, University if Minnesota, Minneapolis, Minnesota, United States

Velcade Consolidation Bone Study

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: bortezomib

First Posted Date: 2011-01-31

Last Posted Date: 2016-05-30

Lead Sponsor: Janssen-Cilag International NV

Target Recruit Count: 106

Registration Number: NCT01286077

Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Ann Arbor Stage III Grade 1 Follicular Lymphoma
Ann Arbor Stage III Grade 3 Follicular Lymphoma
Ann Arbor Stage III Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Ann Arbor Stage IV Grade 1 Follicular Lymphoma
Ann Arbor Stage IV Grade 2 Follicular Lymphoma
Ann Arbor Stage IV Grade 3 Follicular Lymphoma

Interventions: Drug: Bendamustine Hydrochloride
Radiation: Fludeoxyglucose F-18
Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Biological: Ofatumumab
Procedure: Positron Emission Tomography with Radiolabeled Targeting Agent

First Posted Date: 2011-01-31

Last Posted Date: 2024-11-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 135

Registration Number: NCT01286272

Locations: 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Saint Helena Hospital, Saint Helena, California, United States

and more 93 locations

Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)

Not Applicable

Completed

Conditions: Amyloidosis

Interventions: Drug: Bortezomib

First Posted Date: 2011-01-11

Last Posted Date: 2017-04-07

Lead Sponsor: Zhi-Hong Liu, M.D.

Target Recruit Count: 21

Registration Number: NCT01273844

Locations: 🇨🇳
Soochow University, Suzhou, Jiangsu, China

Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation

Phase 2

Completed

Conditions: Contiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Stage I Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma

Interventions: Drug: bortezomib
Biological: rituximab
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: DNA analysis
Other: pharmacological study
Other: pharmacogenomic studies
Other: Questionnaire Administration

First Posted Date: 2010-12-29

Last Posted Date: 2023-07-27

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 23

Registration Number: NCT01267812

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Evaluating the Efficacy and Safety of the Lower Dose of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation- KMM103 Study

Phase 1

Conditions: Multiple Myeloma Patients Who Candidate for Autologous Peripheral Blood Stem Cell Transplantation

Interventions: Drug: Bortezomib

First Posted Date: 2010-12-07

Last Posted Date: 2013-06-04

Lead Sponsor: Yonsei University

Target Recruit Count: 53

Registration Number: NCT01255527

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
🇰🇷
ASAN Medical Center, Seoul, Korea, Republic of
🇰🇷
Ewha Womans University Mokdong Hospital, Seoul, Korea, Republic of

and more 5 locations

Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma
Auto Stem Cell Transplant

Interventions: Drug: Bortezomib

First Posted Date: 2010-11-16

Last Posted Date: 2023-08-22

Lead Sponsor: Hackensack Meridian Health

Target Recruit Count: 146

Registration Number: NCT01241708

Locations: 🇺🇸
John Theurer Cancer Center @ Hackensack University Medical Center, Hackensack, New Jersey, United States

Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: Bendamustin
Drug: bortezomib
Drug: lenalidomide

First Posted Date: 2010-10-07

Last Posted Date: 2023-06-29

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 289

Registration Number: NCT01216683

Locations: 🇺🇸
Longmont United Hospital, Longmont, Colorado, United States
🇺🇸
Graham Hospital Association, Canton, Illinois, United States
🇺🇸
Mcdonough District Hospital, Macomb, Illinois, United States

and more 223 locations

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