NewYork-Presbyterian/Weill Cornell Seeks Patients with Mantle Cell Lymphoma for Clinical Trial with Velcade (Bortezomib) for Injection
Oct 6, 2004
NewYork-Presbyterian Hospital/Weill Cornell Medical Center has announced that it is seeking patients with relapsed or refractory mantle cell lymphoma to participate in a multicenter, single-arm, open-label Phase II trial of VELCADE®.
Mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma, accounts for approximately six percent of all lymphomas. This form of lymphoma is often widespread when diagnosed, and typically involves both lymph nodes and extranodal sites. Mantle cell lymphoma is not curable with existing therapies, and only one-fifth of patients survive more than five years following diagnosis.
VELCADE® and proteasome inhibition represent a completely new approach to treating cancer. The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins that control the cell cycle and cellular processes. By blocking the proteasome, VELCADE® disrupts numerous biologic pathways, including those related to growth and survival of some cancer cells.
"VELCADE® is a novel therapy with a unique mechanism of action," said Dr. John Leonard, chief trial investigator, Clinical Director of the Center for Lymphoma and Myeloma and Associate Attending Physician at NewYork-Presbyterian/Weill Cornell. "We're pleased to be able to participate in this trial because patients with treatment-resistant mantle cell lymphoma are in desperate need of potential new therapeutic options."
Dr. Leonard is also Associate Professor of Medicine at Weill Cornell Medical College.
The primary endpoints of the trial are time to disease progression and response rates. Duration of response and overall survival also will be measured.
To be eligible for the study, adult patients must have:
- Documented relapse or progression following one or two chemotherapy regimens, with at least one regimen having included anthracycline or mitoxantrone;
- Pathologically confirmed mantle cell lymphoma with either cyclin D overexpression or (11;14) translocation;
- At least one measurable site of disease that has not been previously irradiated or has grown since previous irradiation;
- Karnofsky performance status > 50 percent (a performance scale that rates a person's normal activities and that can be used to evaluate a patient's progress after a therapeutic procedure); and
- Other criteria specified by the investigators.
NewYork-Presbyterian Hospital/Weill Cornell Medical Center is among an estimated 30 centers internationally participating in the trial. This trial is currently enrolling patients. Upon completion of the 12-month treatment protocol, patients will be followed every six weeks until progressive disease is confirmed. Prospective participants can call 1-866-VELCADE (835-2233) for more information about eligibility or to find a study site in their area.
VELCADE®, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma — a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003, to market VELCADE® 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. On April, 27, 2004, the European Commission granted marketing authorization for VELCADE® for the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on their last therapy.
VELCADE®is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development; Millennium is responsible for commercialization of VELCADE® in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and, subject to regulatory approvals, the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.
VELCADE®has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE®is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE®in two Phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (65 percent); nausea (64 percent); diarrhea (51 percent); decreased appetite (including anorexia) (43 percent); constipation (43 percent); thrombocytopenia (43 percent); peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent); pyrexia (36 percent); vomiting (36 percent); and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade-four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent), and nausea (4 percent). Risks that may be associated with VELCADE®include peripheral neuropathy, orthostatic hypotension, and thrombocytopenia. Patients should be closely monitored and, if necessary, the dose should be modified. Women of child-bearing potential should avoid becoming pregnant while being treated with VELCADE®.
For more information about VELCADE®clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE.
Millennium Pharmaceuticals Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE®, a novel cancer product, co-promotes Integrilin® (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products.
About NewYork-Presbyterian Hospital/Weill Cornell Medical Center
The NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and its academic partner Weill Cornell Medical College. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory, and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education, and community service.
This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the commercial success of INTEGRILIN and VELCADE®; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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