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Bortezomib

Generic Name
Bortezomib
Brand Names
Velcade, Bortezomib Accord, Bortezomib Hospira, Bortezomib Fresenius Kabi, Bortezomib Sun
Drug Type
Small Molecule
Chemical Formula
C19H25BN4O4
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
-

Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1
Completed
Conditions
Refractory Multiple Myeloma
Interventions
Drug: Aurora A kinase inhibitor MLN8237
Drug: bortezomib
First Posted Date
2009-12-17
Last Posted Date
2016-05-25
Lead Sponsor
Mayo Clinic
Target Recruit Count
26
Registration Number
NCT01034553
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

and more 3 locations

A Retreatment Study With Bortezomib for Multiple Myeloma

Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-12-11
Last Posted Date
2013-03-08
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
56
Registration Number
NCT01030302

Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

Phase 2
Completed
Conditions
Lymphoma
Interventions
First Posted Date
2009-12-10
Last Posted Date
2016-08-19
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
55
Registration Number
NCT01029730
Locations
🇺🇸

Florida Cancer Specialists, Ft. Myers, Florida, United States

🇺🇸

Hematology Oncology of the North Shore, Skokie, Illinois, United States

🇺🇸

Holy Cross Hospital, Ft. Lauderdale, Florida, United States

and more 17 locations

Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.

Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-12-04
Last Posted Date
2014-04-28
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
104
Registration Number
NCT01026701

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Phase 3
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-12-02
Last Posted Date
2020-03-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
767
Registration Number
NCT01023308
Locations
🇬🇧

Novartis Investigative Site, Wolverhampton, United Kingdom

Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-11-30
Last Posted Date
2014-12-23
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
140
Registration Number
NCT01021592

Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma

Phase 1
Completed
Conditions
AIDS-Related Kaposi Sarcoma
Recurrent Kaposi Sarcoma
HIV Infection
Interventions
Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
First Posted Date
2009-11-19
Last Posted Date
2018-02-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
24
Registration Number
NCT01016730
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

and more 6 locations

IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
Drug: IV busulfan
Drug: bortezomib
Procedure: Autologous Hematopoietic Stem Cell Transplant (HSCT)
First Posted Date
2009-11-09
Last Posted Date
2014-09-25
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
30
Registration Number
NCT01009840
Locations
🇺🇸

Arizona Cancer Center, Tucson, Arizona, United States

🇺🇸

The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

🇺🇸

University of Maryland School of Medicine - Marlene & Stewart Greenebaum Cancer Center, Baltimore, Maryland, United States

and more 10 locations

Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)

Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-11-01
Last Posted Date
2013-02-20
Lead Sponsor
Janssen Korea, Ltd., Korea
Target Recruit Count
1121
Registration Number
NCT01005628

Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

Phase 3
Terminated
Conditions
Multiple Myeloma
Interventions
First Posted Date
2009-10-27
Last Posted Date
2018-02-09
Lead Sponsor
AEterna Zentaris
Target Recruit Count
135
Registration Number
NCT01002248
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇮🇪

Keryx / AOI Pharmaceuticals Investigative Site, Dublin 7, Ireland

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