Velcade(R) (bortezomib) for Injection Multiple Myeloma Retreatment Clinical Trial Initiated
Thursday March 10, 8:01 am ET
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- Company-sponsored trial in patients previously treated with Velcade reinforces commitment to addressing unmet medical needs --
CAMBRIDGE, Mass., March 10 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the initiation of EVEREST (Evaluation of VELCADE Employed as Retreatment for Efficacy, Safety and Tolerability). This is a multicenter phase IV clinical trial of VELCADE in multiple myeloma (MM) patients who have previously responded to VELCADE and relapsed following a treatment-free remission. Efficacy of retreatment with VELCADE will be assessed in terms of best confirmed M-protein response.
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"VELCADE has proven efficacy in patients with relapsed and refractory myeloma, with responses lasting approximately one year," said David Schenkein, M.D., senior vice president, clinical research, Millennium. "When these patients relapse, they have few treatment options. There is no known mechanism of resistance to VELCADE, and no new cumulative toxicity with extended therapy, so we are optimistic about the benefits of retreatment which would allow patients to receive multiple lines of therapy with VELCADE."
The open-label, clinical trial will be conducted at approximately 80 sites in North America and will enroll up to approximately 120 patients. Eligible patients need to have tolerated 1.0 or 1.3mg/m2 doses of VELCADE alone or in combination with dexamethasone, have had a reduction of M-protein of 50 percent or more that has lasted at least six months with a treatment-free interval of at least four months. In the EVEREST trial, the maximum number of cycles will be dependent on patient response and investigator discretion.
To date, approximately 12,000 patients have been treated with VELCADE. VELCADE is currently approved in approximately 40 countries around the world, including the United States, for treatment of multiple myeloma (MM) patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. On September 29, 2004, Millennium filed a sNDA for VELCADE as a treatment for patients with MM who have received at least one prior therapy. The sNDA is currently under Priority Review at the U.S. Food and Drug Administration. Millennium and Johnson & Johnson Pharmaceutical Research and Development L.L.C. continue to investigate VELCADE globally in phase I, II and III clinical trials in both hematologic and solid tumors, including frontline MM, non-Hodgkin's lymphoma and lung, prostate and ovarian cancers.
About Multiple Myeloma (MM)
Multiple myeloma is a cancer of the bone marrow in which white blood cells called plasma cells, normally responsible for the production of antibodies (proteins that fight infection and disease), are overproduced. The proliferation of these abnormal plasma cells, known as myeloma cells, causes decreased production of normal red and white blood cells, and of normal disease-fighting antibodies, as well as the growth of tumors that spread to multiple sites -- hence the term multiple myeloma. The decreased white blood cell production damages the immune system while the myeloma tumors cause bone destruction that manifests as pain and fractures.
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the United States, more than 40,000 individuals have MM and over 14,000 new cases of the disease are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths due to multiple myeloma each year.
About VELCADE® (bortezomib) for Injection
VELCADE is approved 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. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 228 patients who were treated with VELCADE 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65%), nausea (64%), diarrhea (51%), decreased appetite including anorexia (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%), vomiting (36%), and anemia (32%). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3%) and neutropenia (3%). A total of 113 (50%) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%), dehydration (5%), and nausea (4%).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE |
