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, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Lenalidomide
Drug: dexamethasone

First Posted Date: 2006-09-19

Last Posted Date: 2024-11-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 68

Registration Number: NCT00378105

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

S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: bortezomib
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate

First Posted Date: 2006-09-15

Last Posted Date: 2017-11-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 68

Registration Number: NCT00376961

Locations: 🇺🇸
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
🇺🇸
Alaska Regional Hospital Cancer Center, Anchorage, Alaska, United States
🇺🇸
Providence Cancer Center, Anchorage, Alaska, United States

and more 143 locations

Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Drug: bortezomib
Drug: gemcitabine hydrochloride

First Posted Date: 2006-09-15

Last Posted Date: 2023-08-04

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 29

Registration Number: NCT00377052

Locations: 🇨🇦
London Regional Cancer Program, London, Ontario, Canada
🇨🇦
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
🇨🇦
Odette Cancer Centre, Toronto, Ontario, Canada

and more 8 locations

Phase I/II Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma

Phase 1

Terminated

Conditions: Lymphoma

Interventions: Drug: rituximab
Drug: bortezomib
Drug: Ibritumomab tiuxetan

First Posted Date: 2006-09-07

Last Posted Date: 2019-09-04

Lead Sponsor: Northwestern University

Target Recruit Count: 18

Registration Number: NCT00372905

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States

Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

Phase 2

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: Rituximab
Drug: bortezomib

First Posted Date: 2006-08-29

Last Posted Date: 2019-09-06

Lead Sponsor: Northwestern University

Target Recruit Count: 42

Registration Number: NCT00369707

Locations: 🇺🇸
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
🇺🇸
Hematology-Oncology Associates of Illinois, Chicago, Illinois, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 1 locations

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

First Posted Date: 2006-08-18

Last Posted Date: 2012-04-06

Lead Sponsor: Accelerated Community Oncology Research Network

Target Recruit Count: 32

Registration Number: NCT00366106

Locations: 🇺🇸
Augusta Oncology Associates, PC, Augusta, Georgia, United States
🇺🇸
Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States
🇺🇸
Mid Ohio Oncology/Hematology, Inc., Columbus, Ohio, United States

and more 12 locations

Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer

Interventions: Drug: docetaxel
Drug: bortezomib
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: pharmacological study

First Posted Date: 2006-08-15

Last Posted Date: 2017-12-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 81

Registration Number: NCT00362882

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

Ph II CHOP+Velcade in Mediastinal LBCL

Phase 2

Terminated

Conditions: Non-Hodgkin's Lymphoma

First Posted Date: 2006-08-08

Last Posted Date: 2012-12-03

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 3

Registration Number: NCT00361621

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients

Phase 2

Completed

Conditions: Multiple Myeloma

First Posted Date: 2006-07-28

Last Posted Date: 2006-12-04

Lead Sponsor: University of Turin, Italy

Target Recruit Count: 30

Registration Number: NCT00358020

Locations: 🇮🇹
Divisione Di Ematologia, Ospedali Riuniti, Reggio Calabria, Italy
🇮🇹
Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello, Palermo, Italy
🇮🇹
Cattedra E Divisione Di Ematologia, Università Tor Vergata, Ospedale S.Eugenio, Roma, Italy

and more 4 locations

PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

Phase 1

Completed

Conditions: Recurrent Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Burkitt Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Primary Central Nervous System Non-Hodgkin Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Angioimmunoblastic T-cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma

Interventions: Drug: belinostat
Drug: bortezomib
Other: pharmacological study

First Posted Date: 2006-07-06

Last Posted Date: 2013-05-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT00348985

Locations: 🇺🇸
University of Colorado, Denver, Colorado, United States

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