Bortezomib

(Velcade®)

Bortezomib

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous or intravenous; 3.5 mg)
Drug ClassProteasome inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with multiple myeloma
  • Indicated for the treatment of adult patients with mantle cell lymphoma.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
  • Progression-Free Survival (PFS): In high-risk newly diagnosed multiple myeloma (NDMM) patients, bortezomib showed a median PFS of 30.4 months compared to lenalidomide's 31.7 months (hazard ratio (HR) = 0.966, 95% confidence interval (CI): 0.628-1.486, p = 0.874). Bortezomib demonstrated significant PFS improvement over placebo (HR = 0.72, 95% CI 0.55-0.95, p = 0.02). Lenalidomide-carfilzomib was superior to bortezomib-thalidomide for PFS (odds ratio (OR) range: 2.18-2.20).
  • Overall Survival (OS): Bortezomib-based maintenance therapy improved OS in comparison with lenalidomide (HR = 0.71, 95% CI 0.58-0.87, p = 0.001). The lenalidomide-carfilzomib regimen showed superior OS over bortezomib-thalidomide. Additional benefits in OS were observed with bortezomib added to rituximab in diffuse large B-cell lymphoma (DLBCL).
  • Response Rates: Carfilzomib (CFZ) with daratumumab achieved an overall response rates (ORR) close to 100%. Bortezomib in combination regimens also demonstrated high ORR. Bortezomib-based consolidation therapies enhanced complete response rates (CR), while acalabrutinib reported significant improvements in ORR and CR over bortezomib.
  • Comparative Effectiveness: Bortezomib-based regimens generally showed comparable PFS to lenalidomide in high-risk NDMM. In comparative analyses, bortezomib regimens ranked highly for PFS and OS across different combinations and conditions, with some combinations showing superior efficacy over others.
  • Bortezomib-induced peripheral neuropathy (BIPN) incidence ranged from 8.4% to 80.5% (median 37.8%), with severe neuropathy (grade 3-4) occurring in 1% to 33.2% (median 8%); reduced neuropathy incidence was observed with once-weekly versus twice-weekly dosing.
  • Bortezomib-based regimens commonly resulted in hematological toxicity, cardiovascular disturbances, electrolyte imbalances, diarrhea, and thrombocytopenia, with a noted increase in grade 3 or higher adverse events, although maintenance therapy did not significantly increase severe peripheral neuropathy or secondary primary malignancies compared to placebo/thalidomide.
  • Bortezomib-based regimens had increased risk for grade 3-4 neurological, gastrointestinal, and fatigue symptoms, while acalabrutinib demonstrated a comparatively better safety profile.
  • High-risk NDMM patients demonstrated comparable PFS with lenalidomide and bortezomib; in refractory multiple myeloma (RRMM), pomalidomide, bortezomib, and dexamethasone ranked highest for PFS, while bortezomib-melphalan-prednisone (VMP) was effective as first-line treatment in transplant-ineligible multiple myeloma (MM); in DLBCL, adding bortezomib to rituximab improved event-free survival; specific safety considerations for hematological malignancies highlighted efficacy and improved safety with once-weekly bortezomib, while non-hematological toxicities were notable in cardiovascular subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Velcade (bortezomib) Prescribing Information.2021Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Maintenance therapy for cytogenetically high-risk multiple myeloma: landscape in the era of novel drugs2024Clinical and Experimental Medicine
Efficacy of maintenance treatment in patients with multiple myeloma: a systematic review and network meta-analysis2022Hematology (amsterdam, Netherlands)
Multinomial network meta-analysis using response rates: relapsed/refractory multiple myeloma treatment rankings differ depending on the choice of outcome2022Bmc Cancer
Efficacy of first-line treatment options in transplant-ineligible multiple myeloma: A network meta-analysis2021Critical Reviews in Oncology/hematology
Efficacy and Toxicity Profile of Carfilzomib-Based Regimens for Treatment of Newly Diagnosed Multiple Myeloma: A Systematic Review2021Oncotargets and Therapy
Comparison of monoclonal antibodies targeting CD38, SLAMF7 and PD-1/PD-L1 in combination with Bortezomib/Immunomodulators plus dexamethasone/prednisone for the treatment of multiple myeloma: an indirect-comparison Meta-analysis of randomised controlled trials2021Bmc Cancer
The role of novel agents for consolidation after autologous transplantation in newly diagnosed multiple myeloma: a systematic review2021Annals of Hematology
Efficacy of proteasome inhibitor-based maintenance following autologous transplantation in multiple myeloma: A systematic review and meta-analysis2021European Journal of Haematology
Network meta-analysis of targeted therapies for diffuse large B cell lymphoma2020Bmc Cancer
The proteasome as a druggable target with multiple therapeutic potentialities: Cutting and non-cutting edges2020Pharmacology & Therapeutics
Bortezomib-based consolidation or maintenance therapy for multiple myeloma: a meta-analysis2020Blood Cancer Journal
Population-based meta-analysis of bortezomib exposure-response relationships in multiple myeloma patients2020Journal of Pharmacokinetics and Pharmacodynamics
Characteristics and risk factors of bortezomib induced peripheral neuropathy: A systematic review of phase III trials2020Hematological Oncology
The effects of different schedules of bortezomib, melphalan, and prednisone for patients with newly diagnosed multiple myeloma who are transplant ineligible: a matching-adjusted indirect comparison2020Leukemia & Lymphoma
Multiple drug combinations of bortezomib, lenalidomide, and thalidomide for first-line treatment in adults with transplant-ineligible multiple myeloma: a network meta-analysis2019The Cochrane Database of Systematic Reviews
Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma2019Clinical Therapeutics
Upfront treatment for newly diagnosed transplant-ineligible multiple myeloma patients: A systematic review and network meta-analysis of 14,533 patients over 29 randomized clinical trials2019Critical Reviews in Oncology/hematology

Clinical Practice Guidelines

Document TitleYearSource
Clinical practice guideline multiple myeloma.2022Medical Scientific Advisory Group (MSAG) to Myeloma Australia (MA)
Multiple myeloma, version 3.2021, NCCN clinical practice guidelines in oncology.2021Journal of the National Comprehensive Cancer Network