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

Study of Patients With Stage IV Malignant Melanoma Using PS-341 (Bortezomib, Velcade) and Interferon-alpha-2b in Malignant Melanoma

Phase 1

Completed

Conditions: Melanoma

Interventions: Drug: Bortezomib
Drug: Interferon Alfa-2b

First Posted Date: 2011-10-31

Last Posted Date: 2015-01-13

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 16

Registration Number: NCT01462773

Locations: 🇺🇸
Ohio State University, Columbus, Ohio, United States

Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Melphalan
Drug: Bortezomib

First Posted Date: 2011-10-17

Last Posted Date: 2023-11-28

Lead Sponsor: Hackensack Meridian Health

Target Recruit Count: 63

Registration Number: NCT01453088

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States

Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

Phase 3

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Rituximab
Drug: High dose Ara-C
Drug: Dexamethasone
Drug: Bortezomib

First Posted Date: 2011-10-10

Last Posted Date: 2017-03-07

Lead Sponsor: Prof. Dr. M. Dreyling (co-chairman)

Target Recruit Count: 128

Registration Number: NCT01449344

Locations: 🇫🇷
Hôpital Henri Mondor, Service hématologie, Créteil, France
🇫🇷
CHU de Nice, Service hématologie, Nice, France
🇩🇪
Asklepios Klinik St. Georg, Abteilung Hämatologie, Hamburg, Germany

and more 51 locations

Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients

Phase 1

Completed

Conditions: Myeloma

Interventions: Drug: Panobinostat
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone
Behavioral: Symptom Questionnaire

First Posted Date: 2011-09-26

Last Posted Date: 2019-03-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 77

Registration Number: NCT01440582

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011)

Phase 1

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Rituximab
Drug: bortezomib
Drug: Cladribine

First Posted Date: 2011-09-23

Last Posted Date: 2017-08-07

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 13

Registration Number: NCT01439750

Locations: 🇺🇸
Penn State Cancer Institute, Hershey, Pennsylvania, United States
🇺🇸
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Ph 1b Study to Evaluate GSK2110183 in Combination With Bortezomib and Dexamethasone in Subjects With Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: GSK2110183
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2011-09-05

Last Posted Date: 2018-08-08

Lead Sponsor: Novartis

Target Recruit Count: 90

Registration Number: NCT01428492

Locations: 🇨🇳
Novartis Investigative Site, Taipei, Taiwan

Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Therapy-Related Acute Myeloid Leukemia

Interventions: Drug: Decitabine
Drug: Bortezomib
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2011-08-22

Last Posted Date: 2023-02-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 165

Registration Number: NCT01420926

Locations: 🇺🇸
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
🇺🇸
East Carolina University, Greenville, North Carolina, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 50 locations

Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Lymphoma
Neurotoxicity
Therapy-related Toxicity

Interventions: Biological: rituximab
Drug: bendamustine hydrochloride
Drug: lenalidomide
Drug: bortezomib

First Posted Date: 2011-08-12

Last Posted Date: 2024-12-04

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 373

Registration Number: NCT01415752

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Mount Sinai Hospital Medical Center, Chicago, Illinois, United States

and more 413 locations