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)

Discovery Of New Way Protein Degradation Is Regulated Has Implications For Multiple Myeloma, Muscle Wasting, Neurodegeneration
Source: Bones / Orthopedics News From Medical News Today [2013.04.30]
Proteins, unlike diamonds, aren't forever. And when they wear out, they need to be degraded in the cell back into amino acids, where they will be recycled into new proteins...

Pomalyst Approved for Advanced Multiple Myeloma
Source: MedicineNet Multiple Myeloma Specialty [2013.02.11]
Title: Pomalyst Approved for Advanced Multiple Myeloma
Category: Health News
Created: 2/8/2013 8:35:00 PM
Last Editorial Review: 2/11/2013 12:00:00 AM

Kyprolis Approved for Multiple Myeloma
Source: MedicineNet Multiple Myeloma Specialty [2012.07.23]
Title: Kyprolis Approved for Multiple Myeloma
Category: Health News
Created: 7/20/2012 4:05:00 PM
Last Editorial Review: 7/23/2012 12:00:00 AM

Multiple Myeloma
Source: MedicineNet Hemapheresis Specialty [2008.11.20]
Title: Multiple Myeloma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 11/20/2008 12:00:00 AM

Antibody Offers Possible Treatment For Serious Blood Cancer
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.09]
A single antibody could be the key to treating multiple myeloma, or cancer of the blood, currently without cure or long-term treatment. "We tested the antibody in various ways, including on tumour cells from myeloma patients that have been transplanted into mice...

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Published Studies Related to Velcade (Bortezomib)

Rapid early monoclonal protein reduction after therapy with bortezomib or bortezomib and pegylated liposomal doxorubicin in relapsed/refractory myeloma is associated with a longer time to progression. [2011.08.15]
BACKGROUND: A rapid and early monoclonal (M) protein response during initial therapy in patients with multiple myeloma had been identified as a predictor of superior long-term outcome in some--but not all--studies... CONCLUSIONS: These analyses supported the possibility that a robust early M protein response is a good prognostic factor for long-term outcome of myeloma patients with relapsed and/or refractory disease receiving bortezomib or PLD + bortezomib. Copyright (c) 2011 American Cancer Society.

Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. [2011.08]
BACKGROUND: Bortezomib and rituximab have shown additive activity in preclinical models of lymphoma, and have been shown to be active and generally well tolerated in a randomised phase 2 study in patients with follicular and marginal zone lymphoma. We compared the efficacy and safety of rituximab alone or combined with bortezomib in patients with relapsed or refractory follicular lymphoma in a phase 3 setting... INTERPRETATION: Although a regimen of bortezomib plus rituximab is feasible, the improvement in progression-free survival provided by this regimen versus rituximab alone was not as great as expected. The regimen might represent a useful addition to the armamentarium, particularly for some subgroups of patients. FUNDING: Johnson & Johnson Pharmaceutical Research & Development and Millennium Pharmaceuticals, Inc. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. [2011.05]
BACKGROUND: Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We compared the efficacy and safety of subcutaneous versus intravenous bortezomib at the approved 1.3 mg/m(2) dose and twice per week schedule in patients with relapsed multiple myeloma... INTERPRETATION: Subcutaneous bortezomib offers non-inferior efficacy to standard intravenous administration, with an improved safety profile. FUNDING: Johnson & Johnson Pharmaceutical Research and Development, and Millennium Pharmaceuticals. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Fewer bone disease events, improvement in bone remodeling, and evidence of bone healing with bortezomib plus melphalan-prednisone vs. melphalan-prednisone in the phase III VISTA trial in multiple myeloma. [2011.05]
OBJECTIVES: Bone disease is a key presenting feature of myeloma. This post hoc analysis of the phase III VISTA trial of bortezomib plus melphalan-prednisone (VMP) vs. MP in previously untreated myeloma patients assessed clinical bone disease events and changes in alkaline phosphatase (ALP), a marker for osteoblast activation, and serum Dickkopf-1 (DKK-1), an inhibitor of osteoblast differentiation, during treatment... CONCLUSIONS: These results suggest a positive effect of bortezomib on bone metabolism and potentially bone healing in myeloma. (c) 2011 John Wiley & Sons A/S.

A phase I clinical-pharmacodynamic study of the farnesyltransferase inhibitor tipifarnib in combination with the proteasome inhibitor bortezomib in advanced acute leukemias. [2011.03.01]
CONCLUSIONS: Tipifarnib and bortezomib combination in patients with advanced leukemias was well-tolerated, demonstrated relevant target inhibition, and was associated with signals of clinical activity in patients with advanced and refractory acute leukemias. Future studies of this combination may be warranted in more selected groups of patients in whom these molecular targets are of particular importance. (c)2011 AACR.

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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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Reports of Suspected Velcade (Bortezomib) Side Effects

Death (419),  Neuropathy Peripheral (150),  Diarrhoea (149),  Pneumonia (124),  Pyrexia (110),  Hypotension (108),  Dyspnoea (106),  Thrombocytopenia (100),  Multiple Myeloma (89),  Fatigue (87), more >>