Velcade (Bortezomib) - Summary

VELCADE SUMMARY

VELCADE® (bortezomib) for Injection

VELCADE^® (bortezomib) for Injection is an antineoplastic agent available for intravenous injection (IV) use only. Each single dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. Inactive ingredient: 35 mg mannitol, USP.

VELCADE^® (bortezomib) for Injection is indicated for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.

The effectiveness of VELCADE is based on response rates (CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.

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NEWS HIGHLIGHTS

Media Articles Related to Velcade (Bortezomib)

Approved Lymphoma Drug Shows Promise In Early Tests Against Bone Cancer
Source: Bones / Orthopaedics News From Medical News Today [2009.11.06]
A drug already approved for the treatment of lymphoma may also slow the growth of the most deadly bone cancer in children and teens, according to an early-stage study published online in the International Journal of Cancer. The study drug, Bortezomib, was found to be effective against bone cancer in human cancer cell studies and in mice.

Multiple Myeloma Genome Unlocked
Source: MedicineNet Multiple Myeloma Specialty [2009.07.30]
Title: Multiple Myeloma Genome Unlocked
Category: Health News
Created: 7/30/2009 7:00:00 AM
Last Editorial Review: 7/30/2009

Combo Therapy Helps Multiple Myeloma Patients
Source: MedicineNet thalidomide Specialty [2008.12.15]
Title: Combo Therapy Helps Multiple Myeloma Patients
Category: Health News
Created: 12/13/2008 2:00:00 AM
Last Editorial Review: 12/15/2008

Multiple Myeloma
Source: MedicineNet Essential Mixed Cryoglobulinemia Specialty [2006.08.22]
Title: Multiple Myeloma
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 8/22/2006

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Published Studies Related to Velcade (Bortezomib)

A randomized phase 2 study of erlotinib alone and in combination with bortezomib in previously treated advanced non-small cell lung cancer. [2009.08]
INTRODUCTION: This phase 2 study was conducted to determine the efficacy and safety of erlotinib alone and with bortezomib in patients with non-small cell lung cancer (NSCLC)... CONCLUSION: Insufficient activity was seen with erlotinib plus bortezomib in patients with relapsed/refractory advanced NSCLC to warrant a phase 3 study of the combination.

Effect of the cytochrome P450 2C19 inhibitor omeprazole on the pharmacokinetics and safety profile of bortezomib in patients with advanced solid tumours, non-Hodgkin's lymphoma or multiple myeloma. [2009]
BACKGROUND AND OBJECTIVE: Bortezomib, an antineoplastic for the treatment of relapsed multiple myeloma and mantle cell lymphoma, undergoes metabolism through oxidative deboronation by cytochrome P450 (CYP) enzymes, primarily CYP3A4 and CYP2C19. Omeprazole, a proton-pump inhibitor, is primarily metabolized by and demonstrates high affinity for CYP2C19. This study investigated whether coadministration of omeprazole affected the pharmacokinetics, pharmacodynamics and safety profile of bortezomib in patients with advanced cancer. The variability of bortezomib pharmacokinetics with CYP enzyme polymorphism was also investigated... CONCLUSION: No impact on the pharmacokinetics, pharmacodynamics and safety profile of bortezomib was seen with coadministration of omeprazole. Concomitant administration of bortezomib and omeprazole is unlikely to cause clinically significant drug-drug interactions and is unlikely to have an impact on the efficacy or safety of bortezomib.

Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma. [2008.12]
This phase I study compared pharmacokinetics and pharmacodynamics, and assessed safety and efficacy of intravenous and subcutaneous administration of bortezomib. Relapsed or refractory multiple myeloma patients were randomized to receive bortezomib by standard intravenous bolus (n=12) or subcutaneous injection (n=12) at the recommended dose and schedule (1.3 mg/m2, days 1, 4, 8, 11; eight 21-day cycles)...

Bortezomib is associated with better health-related quality of life than high-dose dexamethasone in patients with relapsed multiple myeloma: results from the APEX study. [2008.11]
Health-related quality of life (HRQL) was prospectively measured during the phase III APEX trial of bortezomib versus dexamethasone in relapsed multiple myeloma patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core (QLQ-C30) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (NTX) side-effects questionnaires were administered at baseline and every 6 weeks up to 42 weeks...

Updated survival analyses after prolonged follow-up of the phase 2, multicenter CREST study of bortezomib in relapsed or refractory multiple myeloma. [2008.11]
The Clinical Response and Efficacy Study of Bortezomib in the Treatment of Relapsing Multiple Myeloma (CREST) demonstrated substantial activity with two dose levels of bortezomib (1.0 and 1.3 mg/m(2)), alone or with dexamethasone, in relapsed or refractory multiple myeloma.

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Clinical Trials Related to Velcade (Bortezomib)

Bortezomib, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory Low-Grade, Follicular, or Mantle Cell Non-Hodgkin's Lymphoma [Recruiting]
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.

Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma [Active, not recruiting]
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.

Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma [Active, not recruiting]
Primary Objective:

1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma.

Secondary Objective

1. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.

Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma [Active, not recruiting]
The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or refractory multiple myeloma (MM).

Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy [Completed]
The purpose of this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment group will be used as the control. The VELCADE single-agent treatment group will be used to determine if VELCADE administered weekly can demonstrate response rates.

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