Clinical Trial Stopped Early Due To Significant Efficacy Advantages of VELCADE® Combination Therapy
North Hollywood, CA, September 20, 2007 - The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians—today announced that 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.
The study found that adding VELCADE to melphalan and prednisone (MP) improved all parameters in newly diagnosed patients including overall survival, complete remission rate and time-to-disease progression, compared to melphalan and prednisone alone. Based on the recommendation of an independent data monitoring committee, the international Phase III VISTA trial (VMP vs. MP) was stopped early, allowing all patients in the trial to have VELCADE added to their therapy at the discretion of their physician.
"Myeloma patients who have failed on previous treatments know the potential of the novel therapies including VELCADE," said Brian G.M. Durie, M.D., chairman and co-founder of the IMF. "These new findings bring VELCADE closer to newly diagnosed patients, and are especially important to patients who are not eligible for stem cell transplants."
VELCADE, co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. outside the U.S., is the first in a new class of medicines called proteasome inhibitors that disrupt the life cycle of a cancer cell. The trial involved 682 newly diagnosed multiple myeloma patients who were ineligible for stem cell transplantation, at 151 clinical trial sites in 22 countries. The data from the trial are expected to be reported either at the American Society of Hematology meeting (ASH) or a major hematology conference later this year.
"Improved overall survival, progression free survival, complete remission rate, and time-to-disease progression, are our goals, and that's just what these interim results demonstrate," added Susan Novis, president and co-founder of the IMF. "Based on these results we believe a broader range of patients will benefit from VELCADE based therapies."
Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It affects an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing numbers and in increasingly younger people.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 120 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF was rated as the number one resource for patients in an independent survey by the Target Research Group. The IMF can be reached at (800) 452-CURE or www.myeloma.org.
For further information, please contact:
International Myeloma Foundation (800) 452-2873
Media: Ann Forster 212-243-7306