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Myeloma Matrix VELCADE® Supplement
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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.
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New Trial: Randomized Phase 3b Study in Previously Untreated Multiple Myeloma Patients: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone (UPFRONT)
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This multicenter study will consist of a Screening period (generally 4 weeks or less), an Induction Treatment period (approximately 6 months), a Maintenance Treatment period (approximately 6 months), and a Post-treatment period.
Click here for a Clinical Trial Fact Sheet on the "Upfront" Velcade Trial.
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Eastern Cooperative Oncology Group Clinical Trial:E1A05
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Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®) & Lenalidomide (Revlimid®) - Dexamethasone (VRD) versus Bortezomib (Velcade®:) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen
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"Ask the Expert" Videos: VELCADE®
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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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Introduction to Proteasome Inhibition
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This video contains an artist's rendering of the proteasome inhibition process.
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THE INTERNATIONAL MYELOMA FOUNDATION APPLAUDS EXPANSION OF VELCADE® FOR PREVIOUSLY UNTREATED PATIENTS IN EUROPE AND CANADA
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With these new approvals, patients with multiple myeloma may now receive VELCADE earlier following an initial disease diagnosis.
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AN EDITORIAL BY DR. BRIAN DURIE FEATURED IN THE NEW ENGLAND JOURNAL OF MEDICINE
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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?"
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PREVIOUSLY UNTREATED PATIENTS COULD BENEFIT FROM FDA APROVAL OF VELCADE® FOR 'FRONT-LINE' USE
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New Indication Provides Treatment-Free Interval As an Option
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FDA EXPANDS VELCADE® LABEL FOR MYELOMA
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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.
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INTERIM FINDINGS FROM GLOBAL TRIAL EXTEND POSITIVE BENEFITS OF VELCADE TO NEWLY DIAGNOSED PATIENTS
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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.
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VISTA Trial Halted because of Better than Expected Interim Results
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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.
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STUDY SHOWS VELCADE® PLUS DOXIL® IMPROVES SURVIVAL IN PREVIOUSLY TREATED PATIENTS WITH MYELOMA
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Data Presented at the ASCO Cancer Conference
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THE INTERNATIONAL MYELOMA FOUNDATION REPORTS NEW DRUG COMBINATION - VELCADE® PLUS DOXIL® - APPROVED FOR MYELOMA
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Combination Provides 43% Improvement in Time to Disease Progression
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VELCADE® Overcomes Poor Prognosis of del(13) In Multiple Myeloma
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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.
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VELCADE® for injection receives EU authorisation for second-line use in multiple myeloma
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The European Commission has approved the use of VELCADE® (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma.
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FDA Approves VELCADE® for Use in Second-Line Multiple Myeloma
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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.
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FDA Approves VELCADE® for Multiple Myeloma Treatment
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New results for VELCADE® in previously untreated myeloma
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New results for VELCADE® in relapsed myeloma
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New Clinical Trial Fact Sheet on the "Upfront" Velcade Trial
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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.
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Frequently Asked Questions about VELCADE® (bortezomib) for Injection
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Millennium Pharmaceuticals' information for healthcare professionals
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Questions and Answers about VELCADE® (bortezomib) for Injection
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Millennium Pharmaceuticals' booklet for patients and caregivers.
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The VELCADE® Website
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Information for patients and clinicans on indications and usage.
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Millennium's Web Site
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