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

Vorinostat, Bortezomib, and Doxorubicin Hydrochloride Liposome in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: bortezomib
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: vorinostat

First Posted Date: 2008-09-01

Last Posted Date: 2018-01-18

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 32

Registration Number: NCT00744354

Locations: 🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
🇺🇸
Mount Sinai Medical Center, New York, New York, United States

and more 1 locations

Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Acute Myeloid Leukemia
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)

Interventions: Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: bortezomib

First Posted Date: 2008-08-28

Last Posted Date: 2014-09-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 95

Registration Number: NCT00742625

Locations: 🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States
🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

and more 19 locations

Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2008-08-27

Last Posted Date: 2013-12-18

Lead Sponsor: Oncotherapeutics

Target Recruit Count: 35

Registration Number: NCT00742404

Locations: 🇺🇸
James R. Berenson MD, Incorporated, West Hollywood, California, United States
🇺🇸
San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido, Escondido, California, United States
🇺🇸
Comprehensive Blood and Cancer Center, Bakersfield, California, United States

and more 9 locations

Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: bortezomib
Drug: dexamethasone
Drug: Bendamustine

First Posted Date: 2008-08-25

Last Posted Date: 2016-03-16

Lead Sponsor: French Innovative Leukemia Organisation

Target Recruit Count: 39

Registration Number: NCT00740415

Locations: 🇫🇷
CHU de Grenoble - Hopital Michallon, Grenoble, France

Bortezomib With Melphalan and Prednisone for Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Melphalan
Drug: Prednisone

First Posted Date: 2008-08-14

Last Posted Date: 2023-11-07

Lead Sponsor: Duke University

Target Recruit Count: 45

Registration Number: NCT00734149

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone
Drug: Doxil

First Posted Date: 2008-07-29

Last Posted Date: 2017-06-02

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 74

Registration Number: NCT00724568

Locations: 🇺🇸
Dana Farber Cancer Institute (and Massachusetts General), Boston, Massachusetts, United States
🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Emory University Hospital, Atlanta, Georgia, United States

and more 3 locations

S0629, Observation or Combination Chemotherapy, Bortezomib, Thalidomide, and Rituximab Followed By Two Autologous Peripheral Blood Stem Cell Transplants in Treating Patients With Waldenstrom Macroglobulinemia

Phase 2

Withdrawn

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: bortezomib
Drug: carmustine
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: melphalan
Drug: thalidomide
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2008-07-29

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT00723658

Locations: 🇺🇸
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
🇺🇸
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
🇺🇸
Sparrow Regional Cancer Center, Lansing, Michigan, United States

and more 26 locations