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Understanding VELCADE® (bortezomib) for Injection Therapy
07.29.08
















You can view the entire document as a PDF by clicking on the PDF icon on the right or by requesting a free hard copy from the Foundation.

This booklet has been developed to help you learn more about VELCADE® (bortezomib). After reading this booklet, you should know:

  • What VELCADE® is
  • How VELCADE® works
  • The possible side effects of VELCADE®
  • How VELCADE® is given.

This booklet is meant to provide you with general information only. It is not meant to replace the advice of your doctor or nurse. Your doctor or nurse can answer questions related to your specific treatment plan.
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Understanding VELCADE® (bortezomib) for Injection Therapy
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Questions and Answers about VELCADE® (bortezomib) for Injection
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Millennium's Web Site


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Clinical Trials
Open Velcade® (bortezomib) Trials
Myeloma Matrix VELCADE® Supplement
IMPORTANT NOTE: In June, 2008, VELCADE®’s approval was expanded to include previously untreated myeloma patients. This document presents the Current Status of VELCADE® in U.S. and Foreign Clinical Trials as of May 2008.
Eastern Cooperative Oncology Group Clinical Trial:E1A05
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The experts talk about VELCADE® in clinical trials, as frontline therapy and for relapsed patients, alone and in trials with various other agents.
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This video contains an artist's rendering of the proteasome inhibition process.
News
VELCADE® Adds Long-Term Overall Survival Benefit to Label
With suvivival data from VISTA trial, FDA makes VELCADE first front-line multiple myeloma therapy to include overall survival benefit after three-year follow-up in label.
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With these new approvals, patients with multiple myeloma may now receive VELCADE earlier following an initial disease diagnosis.
AN EDITORIAL BY DR. BRIAN DURIE FEATURED IN THE NEW ENGLAND JOURNAL OF MEDICINE
Dr. Durie says that the statistics from the VISTA trial leave no doubt that combination therapy with bortezomib is superior to MP alone. However, he raises the issue, "how does this clear-cut evidence inform treatment decisions?"
PREVIOUSLY UNTREATED PATIENTS COULD BENEFIT FROM FDA APROVAL OF VELCADE® FOR 'FRONT-LINE' USE
New Indication Provides Treatment-Free Interval As an Option
FDA EXPANDS VELCADE® LABEL FOR MYELOMA
The FDA granted approval for VELCADE use, without dose adjustments, in patients with impaired kidney function, including those requiring dialysis. Impaired kidney function is a common complication related to myeloma, affecting approximately 30% of patients at diagnosis and a much larger percentage throughout the course of the disease.
INTERIM FINDINGS FROM GLOBAL TRIAL EXTEND POSITIVE BENEFITS OF VELCADE TO NEWLY DIAGNOSED PATIENTS
The combination therapy of VELCADE, melphalan and prednisone (VMP) demonstrates a significant advantage for patients newly diagnosed with myeloma. The therapy is already approved for use in patients who have received a previous treatment.
VISTA Trial Halted because of Better than Expected Interim Results
Interim analysis results of the large, international Phase III VISTA(1) trial in patients with newly diagnosed multiple myeloma showed that the therapy of VELCADE, melphalan and prednisone (VMP) demonstrated a highly statistically significant improvement in all efficacy measures.
STUDY SHOWS VELCADE® PLUS DOXIL® IMPROVES SURVIVAL IN PREVIOUSLY TREATED PATIENTS WITH MYELOMA
Data Presented at the ASCO Cancer Conference
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Combination Provides 43% Improvement in Time to Disease Progression
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According to results recently presented at the 2005 ASCO meeting, treatment with Velcade (bortezomib) may overcome the poor prognosis associated with del(13), considered a poor prognostic indicator for survival in multiple myeloma.
VELCADE® for injection receives EU authorisation for second-line use in multiple myeloma
The European Commission has approved the use of VELCADE® (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma.
FDA Approves VELCADE® for Use in Second-Line Multiple Myeloma
This approval expands the label to include the treatment of multiple myeloma patients who have received at least one prior therapy. The approval was based on data from the randomized Phase III APEX study that compared single-agent VELCADE to high-dose dexamethasone. The study demonstrated a statistically significant survival advantage in the VELCADE arm of the study.
FDA Approves VELCADE® for Multiple Myeloma Treatment
New results for VELCADE® in previously untreated myeloma
New results for VELCADE® in relapsed myeloma
Publications
New Clinical Trial Fact Sheet on the "Upfront" Velcade Trial
This is a three-arm, randomized trial for patients who have not been treated for myeloma and who are not candidates for high-dose chemotherapy and stem cell transplant. Patients will be randomly assigned to receive one of three treatments ( VTD, VD, or VMP). Patients will know which therapy they’re receiving.
Understanding VELCADE® (bortezomib) for Injection Therapy
Part of the IMF's Understanding series, this booklet covers the basics, including: What is VELCADE®? How does it work? What are the side effects?
Frequently Asked Questions about VELCADE® (bortezomib) for Injection
Millennium Pharmaceuticals' information for healthcare professionals
Questions and Answers about VELCADE® (bortezomib) for Injection
Millennium Pharmaceuticals' booklet for patients and caregivers.
Links
The VELCADE® Website
Information for patients and clinicans on indications and usage.
Millennium's Web Site
12650 Riverside Drive, Suite 206 | North Hollywood, CA 91607-3421 | USA
Hotline:800-452-2873 or 818-487-7455
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