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 and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis

Phase 3

Completed

Conditions: Amyloidosis

Interventions: Drug: Bortezomib
Drug: dexamethasone
Biological: filgrastim
Procedure: autologous hematopoietic stem cell transplantation (ASCT)
Drug: Melphalan

First Posted Date: 2013-11-29

Last Posted Date: 2013-11-29

Lead Sponsor: Nanjing University School of Medicine

Target Recruit Count: 56

Registration Number: NCT01998503

Locations: 🇨🇳
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu, China

Bortezomib Maintenance in High Risk DLBCL

Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Interventions: Drug: Bortezomib

First Posted Date: 2013-10-18

Last Posted Date: 2020-10-23

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 59

Registration Number: NCT01965977

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma in Relapse

Interventions: Drug: Panobinostat
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Bortezomib

First Posted Date: 2013-10-18

Last Posted Date: 2021-09-05

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 21

Registration Number: NCT01965353

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma

Phase 1

Terminated

Conditions: Stage II Multiple Myeloma
Stage III Multiple Myeloma
Refractory Multiple Myeloma
Stage I Multiple Myeloma

Interventions: Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Drug: bortezomib
Drug: lenalidomide
Other: laboratory biomarker analysis

First Posted Date: 2013-10-07

Last Posted Date: 2017-02-17

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 8

Registration Number: NCT01954784

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Proteasome Inhibition in Acute Promyelocytic Leukemia

Phase 2

Conditions: Relapsed Acute Promyelocytic Leukemia

Interventions: Drug: Bortezomib

First Posted Date: 2013-09-25

Last Posted Date: 2013-09-25

Lead Sponsor: Christian Medical College, Vellore, India

Target Recruit Count: 30

Registration Number: NCT01950611

Locations: 🇮🇳
Department of Haematology, Christian Medical College, Vellore, TN, India

Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 1

Completed

Conditions: DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: Bortezomib
Radiation: Total-Body Irradiation
Drug: Melphalan
Procedure: Autologous Bone Marrow Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Laboratory Biomarker Analysis

First Posted Date: 2013-09-05

Last Posted Date: 2018-05-24

Lead Sponsor: Mayo Clinic

Target Recruit Count: 11

Registration Number: NCT01936090

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

Bortezomib to Treat Significant Complication of HSCT

Phase 2

Completed

Conditions: Allogeneic Stem Cell Transplantation
Refractory Autoimmune Cytopenia(s)

Interventions: Drug: Bortezomib

First Posted Date: 2013-08-28

Last Posted Date: 2016-10-24

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 4

Registration Number: NCT01929980

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma (MM)

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide

First Posted Date: 2013-08-08

Last Posted Date: 2024-05-22

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 30

Registration Number: NCT01919086

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

and more 3 locations