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

Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis

Phase 3

Completed

Conditions: Light Chain Deposition Disease
Primary Systemic Amyloidosis

Interventions: Drug: melphalan
Drug: dexamethasone
Drug: bortezomib

First Posted Date: 2010-03-02

Last Posted Date: 2022-02-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 11

Registration Number: NCT01078454

Locations: 🇺🇸
Illinois CancerCare-Canton, Canton, Illinois, United States
🇺🇸
Illinois CancerCare-Carthage, Carthage, Illinois, United States
🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

and more 206 locations

Belinostat and Bortezomib in Treating Patients With Relapsed or Refractory Acute Leukemia or Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Chronic Myelogenous Leukemia

Interventions: Drug: bortezomib
Drug: belinostat
Other: laboratory biomarker analysis
Genetic: western blotting
Other: pharmacological study
Other: flow cytometry

First Posted Date: 2010-02-25

Last Posted Date: 2016-04-15

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 41

Registration Number: NCT01075425

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Phase 1

Completed

Conditions: Fallopian Tube Mucinous Adenocarcinoma
Ovarian Clear Cell Adenocarcinoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Mucinous Adenocarcinoma
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma

Interventions: Drug: Bortezomib
Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2010-02-24

Last Posted Date: 2019-08-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 33

Registration Number: NCT01074411

Locations: 🇺🇸
Women and Infants Hospital, Providence, Rhode Island, United States
🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

and more 11 locations

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

Phase 2

Completed

Conditions: Primary Systemic Amyloidosis

Interventions: Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone

First Posted Date: 2010-02-22

Last Posted Date: 2014-04-02

Lead Sponsor: Mayo Clinic

Target Recruit Count: 2

Registration Number: NCT01072773

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: KW-2478
Drug: Bortezomib

First Posted Date: 2010-02-05

Last Posted Date: 2024-04-25

Lead Sponsor: Kyowa Kirin Co., Ltd.

Target Recruit Count: 95

Registration Number: NCT01063907

Locations: 🇺🇸
Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,, Tucson, Arizona, United States
🇺🇸
Pacific Shores Medical Group 1043 Elm Ave, Suite 104, Long Beach, California, United States
🇺🇸
Collaborative Research Group 2320 S Seacrest Blvd, Suite 202, Boynton Beach, Florida, United States

and more 23 locations

Bortezomib Plus Rituximab for EBV+ PTLD

Phase 2

Completed

Conditions: Post-transplant Lymphoproliferative Disease
Solid Organ Transplant
Stem Cell Transplant (Bone Marrow Transplant)
Epstein Barr Virus Infections

Interventions: Drug: bortezomib
Drug: rituximab

First Posted Date: 2010-01-28

Last Posted Date: 2018-02-15

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 7

Registration Number: NCT01058239

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2010-01-26

Last Posted Date: 2017-05-03

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 59

Registration Number: NCT01056276

Locations: 🇺🇸
Hematology Oncology Clinic, LLP, Baton Rouge, Louisiana, United States
🇺🇸
Los Robles Hospital and Medical Center, Thousand Oaks, California, United States
🇺🇸
Florida Cancer Specialists, Ft. Myers, Florida, United States

and more 10 locations

Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

Phase 2

Terminated

Conditions: Pancreatic Cancer

Interventions: Drug: Bortezomib
Drug: Panobinostat

First Posted Date: 2010-01-26

Last Posted Date: 2017-12-28

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 7

Registration Number: NCT01056601

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

S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Withdrawn

Conditions: Multiple Myeloma
Plasma Cell Myeloma

Interventions: Drug: bortezomib
Drug: cisplatin
Drug: cyclophosphamide
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: lenalidomide
Drug: melphalan
Drug: thalidomide
Genetic: gene expression analysis
Genetic: microarray analysis
Other: laboratory biomarker analysis
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation

First Posted Date: 2010-01-25

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT01055301

Locations: 🇺🇸
Harborview Medical Center, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
Group Health Central Hospital, Seattle, Washington, United States

and more 18 locations

A Study of the Combination Vorinostat With Lenalidomide, Bortezomib and Dexamethasone for Patients With Newly Diagnosed Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Vorinostat

First Posted Date: 2009-12-24

Last Posted Date: 2021-11-03

Lead Sponsor: Emory University

Target Recruit Count: 30

Registration Number: NCT01038388

Locations: 🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States

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