Navigation Links
Data on VELCADE(R) (Bortezomib) for Injection Based Therapies to be Presented at the International Myeloma Workshop

CAMBRIDGE, Mass., Feb. 23 /PRNewswire/ -- Millennium: The Takeda Oncology Company today announced that 100 data presentations on VELCADE research will be featured at the Fifth International Myeloma Workshop (IMW) in Washington, D.C., February 26 - March 1, 2009. The 13 oral and 87 poster presentations will include updated results on overall survival and safety of VELCADE based therapies in patients with relapsed or previously untreated multiple myeloma (MM).


"The IMW conference provides a unique forum for worldwide leading researchers to come together and share important data concerning advances in the research on multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "Data presented further establish the benefit of VELCADE based treatment options, and we applaud these investigators' efforts that contribute to the common goal of improved patient outcomes."

Previously Untreated Multiple Myeloma

Presentations at the IMW conference will highlight efficacy, safety and survival data for VELCADE based therapies in patients with previously untreated MM. Notable oral presentations will include:

  • Prolonged therapy improves quality of response, and CR associated with superior outcomes, with VMP
    • Lead investigator: Jean-Luc Harrouseau, M.D., Hospital Hotel-Dieu, Nantes, France
    • Abstract #235 Oral presentation: Friday, February 27, 2:00 pm ET

  • Bortezomib, dexamethasone, cyclophosphamide, lenalidomide (VDCR) has high efficacy in frontline MM
    • Lead investigator: Shaji Kumar, M.D., Associate Professor of Medicine, Mayo Clinic, Rochester, Minnesota
    • Abstract #247 Oral presentation session: Friday, February 27, 1:45 pm ET

Relapsed Multiple Myeloma

Additional data will be presented on studies of VELCADE based therapies for patients with relapsed MM, including two presentations examining VELCADE in combination with novel agents:

  • Phase I study of elotuzumab (HuLuc63) in combination with bortezomib in relapsed multiple myeloma
    • Lead investigator: Andrzej Jakubowiak, M.D., Ph.D., Associate Professor, Department of Hematology/Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan
    • Abstract #264 Oral presentation session: Friday, February 27, 1:30 pm ET

  • Panobinostat & bortezomib phase I trial in multiple myeloma
    • Lead investigator: Orhan Sezer, M.D., Department of Hematology and Oncology, Charite - Universitaetmedizin, Berlin
    • Abstract #337 Oral presentation session: Friday, February 27, 1:45 pm ET

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.


VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is approved in more than 87 countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension throughout therapy, cardiac and pulmonary disorders, reversible posterior leukoencephalopathy syndrome, gastrointestinal adverse events, thrombocytopenia, neutropenia, tumor lysis syndrome and hepatic events. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Nursing mothers are advised not to breastfeed while receiving VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. There have been reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy. Patients on oral antidiabetic medication while receiving VELCADE should check blood sugar levels frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the Phase III, VELCADE plus DOXIL(R) [doxorubicin HCl liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ¿Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website,

Editors' Note: This press release is also available under the Media section of the Company's website at:

    Manisha Pai                           Karen Gobler
    (617) 551-7877                        (617) 444-1392         

SOURCE Millennium: The Takeda Oncology Company
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
2. Publication of Clinical Results Underscores VELCADE(R) (Bortezomib) For Injection Based Therapy As a Standard of Care In Newly Diagnosed Multiple Myeloma Patients
3. Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
4. VELCADE(R) (Bortezomib) for Injection Based Therapy Produced Significant Complete Remission Rates Pre- and Post-Transplantation in IFM Phase III Front-Line Multiple Myeloma Trial
5. Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma
6. Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy
7. FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma
8. Inexpensive and Illegal Buttock - Boosting Injections Not Pretty
9. Radiofrequency treatment better than ethanol injection for small liver tumors
10. Bedford Laboratories(TM) to Begin Shipping Irinotecan HCl Injection
11. Cosmetic Injections A Worthwhile Investment
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College is proud to ... Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD College is honored ... one of twelve colleges and universities in the state of California make the cut. ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients ... central Michigan, have come together on Thanksgiving Day to share the things that ... viewing on the Serenity Point YouTube channel, patients displayed what they wrote on ...
(Date:11/26/2015)... ... ... Jobs in hospital medical laboratories and in the imaging field lead the ... Aureus Medical Group . These fields, as well as travel nursing, ranked ... jobs through the company’s website, , The leading healthcare staffing agency ...
(Date:11/26/2015)... ... ... Indosoft Inc., developer and distributor of the world-class Asterisk based contact center ... reliability. , The new Q-Suite 6 platform is based on the latest Java Enterprise ... a specific piece of software for many key components of the suite. Much of ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... recognized once again for its stellar workplace culture with the company’s Cincinnati office ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati Business Courier’s ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... November 26, 2015 ... "Self Administration of High Viscosity Drugs" report ... has announced the addition of the "Self ... their offering. --> Research and Markets ... the "Self Administration of High Viscosity Drugs" ...
(Date:11/26/2015)... November 26, 2015 ... the "Radioimmunoassay Market by Type (Reagents ... Industry, Academics, Clinical Diagnostic Labs), Application (Research, ... to 2020" report to their offering. ... the addition of the "Radioimmunoassay Market ...
(Date:11/25/2015)... 25, 2015 ... the "Global Brain Monitoring Devices Market ... --> ) has announced the ... Devices Market 2015-2019" report to their ... ( ) has announced the addition ...
Breaking Medicine Technology: