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)

Clinical Trials

Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis

Phase 3

Recruiting

Conditions: AL Amyloidosis

Interventions: Procedure: Biospecimen Collection
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Daratumumab and Hyaluronidase-fihj
Drug: Bortezomib
Procedure: Computed Tomography
Drug: Melphalan
Procedure: Stem Cell Isolation
Drug: Cyclophosphamide
Drug: Dexamethasone
Procedure: Echocardiography
Other: Survey Administration
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

First Posted Date: 2023-09-05

Last Posted Date: 2024-07-08

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 338

Registration Number: NCT06022939

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Siteman Cancer Center-South County, Saint Louis, Missouri, United States

and more 32 locations

Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia

Phase 4

Not yet recruiting

Conditions: Hypophosphatasia

Interventions: Drug: methotrexate
Drug: rituximab
Drug: bortezomib
Drug: IVIg
Drug: Folic Acid

First Posted Date: 2023-08-29

Last Posted Date: 2025-02-18

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 8

Registration Number: NCT06015750

Locations: 🇬🇧
Research Site, Manchester, United Kingdom

Alvocade® (Bortezomib) Safety and Effectiveness Study

Completed

Conditions: Multiple Myeloma, Refractory

Interventions: Drug: Bortezomib

First Posted Date: 2023-08-25

Last Posted Date: 2023-08-25

Lead Sponsor: NanoAlvand

Target Recruit Count: 57

Registration Number: NCT06012383

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Selinexor
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2023-06-13

Last Posted Date: 2023-08-14

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 35

Registration Number: NCT05900882

Locations: 🇨🇳
Nanjing First People's Hospital, Nanjing, Jiangsu, China
🇨🇳
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
🇨🇳
Taizhou People's Hospital, Taizhou, Jiangsu, China

and more 3 locations

High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD

Phase 1

Withdrawn

Conditions: Bone Marrow Transplant Complications
Acute Lymphoblastic Leukemia, Adult
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia

Interventions: Drug: Sitagliptin
Drug: Bortezomib
Drug: Cyclophosphamide

First Posted Date: 2023-06-08

Last Posted Date: 2024-04-29

Lead Sponsor: Indiana University

Registration Number: NCT05895201

Locations: 🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Phase 2

Active, not recruiting

Conditions: High-Risk de Novo Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Bortezomib
Drug: Lenalidomide
Drug: Teclistamab
Drug: Talquetamab

First Posted Date: 2023-05-09

Last Posted Date: 2025-03-19

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 30

Registration Number: NCT05849610

Locations: 🇪🇸
Hospital Germans Trials i Pujol, Badalona, Spain
🇪🇸
Hospital Clinic i Provincial de Barcelona, Barcelona, Spain
🇪🇸
Hospital Doce de Octubre, Madrid, Spain

and more 7 locations

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Phase 1

Recruiting

Conditions: Lymphoblastic Leukemia

Interventions: Drug: Dexamethasone
Drug: Mitoxantrone
Drug: PEG asparaginase
Drug: Bortezomib
Drug: Vorinostat
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Blinatumomab
Drug: Ziftomenib

First Posted Date: 2023-05-08

Last Posted Date: 2025-05-11

Lead Sponsor: Tanja Andrea Gruber

Target Recruit Count: 90

Registration Number: NCT05848687

Locations: 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States

and more 22 locations

Bortezomib for the Treatment of Refractory Rheumatoid Arthritis

Not Applicable

Recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: bortezomib

First Posted Date: 2023-04-10

Last Posted Date: 2023-08-30

Lead Sponsor: Chinese SLE Treatment And Research Group

Target Recruit Count: 20

Registration Number: NCT05805891

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, China

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Patients with Newly Diagnosed Multiple Myeloma

Phase 3

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Isatuximab
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2023-04-07

Last Posted Date: 2025-03-07

Lead Sponsor: University of Heidelberg Medical Center

Target Recruit Count: 514

Registration Number: NCT05804032

Locations: 🇩🇪
University of Würzburg, Med. Klinik und Poliklinik II, Würzburg, Germany
🇩🇪
Universitätsklinikum Magdeburg, Magdeburg, Germany
🇩🇪
Universitätsklinikum Münster, 1. Medizinische Klinik A, Münster, Germany

and more 88 locations

A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)

Phase 2

Recruiting

Conditions: Thalassemia
Sickle Cell Disease
Thalassemia, Beta

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Biological: Rabbit ATG
Drug: Dexamethasone
Drug: Bortezomib
Drug: Rituximab

First Posted Date: 2023-02-21

Last Posted Date: 2025-05-20

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 24

Registration Number: NCT05736419

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Consent only), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Consent only), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey, United States

and more 3 locations

Drug Development Updates

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