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

Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Refractory Multiple Myeloma

Interventions: Drug: pomalidomide
Drug: bortezomib
Drug: dexamethasone
Other: laboratory biomarker analysis
Other: gene expression analysis

First Posted Date: 2010-10-01

Last Posted Date: 2020-04-17

Lead Sponsor: Mayo Clinic

Target Recruit Count: 50

Registration Number: NCT01212952

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

Phase 3

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone
Procedure: Autologous Stem Cell Transplant

First Posted Date: 2010-09-24

Last Posted Date: 2023-12-18

Lead Sponsor: Paul Richardson, MD

Target Recruit Count: 729

Registration Number: NCT01208662

Locations: 🇺🇸
Newton-Wellesley Hospital, Newton, Massachusetts, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Arizona Comprehensive Cancer Center, Tucson, Arizona, United States

and more 41 locations

Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: AT7519M
Drug: Bortezomib

First Posted Date: 2010-08-18

Last Posted Date: 2024-08-02

Lead Sponsor: Astex Pharmaceuticals, Inc.

Target Recruit Count: 18

Registration Number: NCT01183949

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

and more 2 locations

Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Doxorubicin
Drug: Bortezomib
Drug: Filgrastim

First Posted Date: 2010-08-09

Last Posted Date: 2023-10-06

Lead Sponsor: Sherif Farag, MB, BS

Target Recruit Count: 32

Registration Number: NCT01177683

Locations: 🇺🇸
IU Health Central Indiana Cancer Centers, Indianapolis, Indiana, United States
🇺🇸
Metro Health Cancer Care, Wyoming, Michigan, United States
🇺🇸
Community Regional Cancer Center, Indianapolis, Indiana, United States

and more 4 locations

Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Acute Myeloid Leukemia

Interventions: Drug: midostaurin
Drug: Bortezomib
Drug: mitoxantrone hydrochloride
Drug: etoposide
Drug: cytarabine

First Posted Date: 2010-08-04

Last Posted Date: 2016-07-06

Lead Sponsor: Alison Walker

Target Recruit Count: 34

Registration Number: NCT01174888

Locations: 🇺🇸
The Ohio State University Medical Center, Columbus, Ohio, United States

Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer

Phase 1

Completed

Conditions: Mature T-cell and Nk-cell Neoplasms
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Leukemia

Interventions: Drug: bortezomib
Drug: nelfinavir mesylate

First Posted Date: 2010-07-19

Last Posted Date: 2019-05-15

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 18

Registration Number: NCT01164709

Locations: 🇨🇭
Kantonsspital - St. Gallen, St. Gallen, Switzerland
🇨🇭
Inselspital Bern, Bern, Switzerland
🇨🇭
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

and more 1 locations

A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

Phase 2

Terminated

Conditions: Bronchiolitis Obliterans

Interventions: Drug: Bortezomib

First Posted Date: 2010-07-16

Last Posted Date: 2020-04-10

Lead Sponsor: Northwestern University

Target Recruit Count: 17

Registration Number: NCT01163786

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Autologous Hematopoietic Stem Cell Transplant Recipient
Plasma Cell Leukemia
Loss of Chromosome 17p
Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: bortezomib
Drug: fludarabine phosphate
Other: melphalan
Radiation: total marrow irradiation
Drug: tacrolimus
Drug: sirolimus
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis

First Posted Date: 2010-07-15

Last Posted Date: 2024-05-29

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 18

Registration Number: NCT01163357

Locations: 🇺🇸
City of Hope, Duarte, California, United States

Bortezomib for the Treatment of Refractory Chronic Graft-vs-Host Disease(cGVHD)

Phase 2

Conditions: Chronic Graft-versus-host Disease

Interventions: Drug: Bortezomib

First Posted Date: 2010-07-08

Last Posted Date: 2016-01-18

Lead Sponsor: Baylor Research Institute

Target Recruit Count: 25

Registration Number: NCT01158105

Locations: 🇺🇸
Charles A. Cancer Center, Baylor University Medical Center, Dallas, Texas, United States

Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Phase 2

Completed

Conditions: Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7
Metastatic Breast Carcinoma

Interventions: Drug: Fulvestrant
Drug: Bortezomib
Other: Laboratory Biomarker Analysis

First Posted Date: 2010-06-11

Last Posted Date: 2023-11-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 118

Registration Number: NCT01142401

Locations: 🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Maimonides Medical Center, Brooklyn, New York, United States

and more 18 locations

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