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

EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma

Phase 1

Completed

Conditions: Leukemia-Lymphoma, Adult T-Cell

Interventions: Drug: Bortezomib
Drug: Etoposide
Drug: Vincristine
Drug: Doxorubicin
Drug: Prednisone
Drug: Cyclophosphamide
Drug: Raltegravir

First Posted Date: 2009-10-23

Last Posted Date: 2017-03-28

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 18

Registration Number: NCT01000285

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States
🇺🇸
University of Miami Hospital/Sylvester, Miami, Florida, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 3 locations

Vorinostat and Bortezomib in Treating Young Patients With Refractory or Recurrent Solid Tumors, Including Central Nervous System Tumors and Lymphoma

Phase 1

Completed

Conditions: Childhood Burkitt Lymphoma
Childhood Central Nervous System Choriocarcinoma
Childhood Central Nervous System Germ Cell Tumor
Childhood Central Nervous System Germinoma
Childhood Central Nervous System Mixed Germ Cell Tumor
Childhood Central Nervous System Teratoma
Childhood Central Nervous System Yolk Sac Tumor
Childhood Choroid Plexus Tumor
Childhood Craniopharyngioma
Childhood Diffuse Large Cell Lymphoma

Interventions: Drug: vorinostat
Drug: bortezomib
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2009-10-14

Last Posted Date: 2013-07-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT00994500

Locations: 🇺🇸
Baylor College of Medicine, Houston, Texas, United States
🇺🇸
Columbia University Medical Center, New York, New York, United States
🇺🇸
Childrens Memorial Hospital, Chicago, Illinois, United States

and more 3 locations

Bortezomib Before Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 1

Withdrawn

Conditions: Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: allogeneic bone marrow transplantation
Drug: bortezomib
Drug: melphalan
Drug: anti-thymocyte globulin
Drug: sirolimus
Drug: tacrolimus
Radiation: total-body irradiation

First Posted Date: 2009-10-14

Last Posted Date: 2023-01-05

Lead Sponsor: Mayo Clinic

Registration Number: NCT00995059

Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

Phase 2

Completed

Conditions: Non-Hodgkin Lymphoma
Adult Diffuse Large B-Cell Lymphoma
B-Cell Non-Hodgkin Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
T-Cell Non-Hodgkin Lymphoma

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Bortezomib
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Drug: Melphalan
Drug: Rituximab
Drug: Vorinostat

First Posted Date: 2009-10-09

Last Posted Date: 2020-03-18

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 27

Registration Number: NCT00992446

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Presurgery Bortezomib for Recurrent Malignant Gliomas Followed by Postop Bortezomib & Temozolomide

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: Bortezomib
Drug: Temozolomide

First Posted Date: 2009-10-07

Last Posted Date: 2014-01-13

Lead Sponsor: Northwestern University

Target Recruit Count: 10

Registration Number: NCT00990652

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

Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients

Phase 2

Terminated

Conditions: Cancer
Myeloma
Multiple Myeloma

Interventions: Drug: Bortezomib

First Posted Date: 2009-09-24

Last Posted Date: 2016-07-11

Lead Sponsor: University of Utah

Target Recruit Count: 17

Registration Number: NCT00983346

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma

Phase 2

Completed

Conditions: Indolent Lymphoma
SLL
Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: rituximab
Drug: bortezomib
Drug: cladribine

First Posted Date: 2009-09-21

Last Posted Date: 2019-12-30

Lead Sponsor: University of Arizona

Target Recruit Count: 24

Registration Number: NCT00980395

Locations: 🇺🇸
The University of Arizona Cancer Center, Tucson, Arizona, United States

Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients With Multiple Myeloma Relapsed After 1-3 Prior Lines of Therapy

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Zoledronic Acid
Drug: Dexamethasone

First Posted Date: 2009-09-09

Last Posted Date: 2014-08-05

Lead Sponsor: University of Athens

Target Recruit Count: 17

Registration Number: NCT00972959

Locations: 🇬🇷
Department of Clinical Therapeutics, University of Athens School of Medicine, "Alexandra" General Hospital, Athens, Greece
🇬🇷
Department of Hematology, "Theagenion" Cancer Center, Thessaloniki, Greece
🇬🇷
Department of Hematology & Medical Research, 251 General Air Force Hospital, Athens, Greece

Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.

Phase 2

Completed

Conditions: Recurrent Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma

Interventions: Drug: Bortezomib
Drug: Carboplatin
Drug: Etoposide
Drug: Ifosfamide

First Posted Date: 2009-08-27

Last Posted Date: 2020-04-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT00967369

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 1

Completed

Conditions: Leukemia
Lymphoma

Interventions: Drug: Bortezomib
Drug: Romidepsin

First Posted Date: 2009-08-21

Last Posted Date: 2018-04-23

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 18

Registration Number: NCT00963274

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States

and more 2 locations

Drug Development Updates

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