Open-source, collaborative study initiated to advance understanding of real-world experience with therapies and clinical outcomes in patients with newly diagnosed and relapsed/refractory multiple myeloma
Cambridge, Mass. and Osaka, Japan, August 31, 2016 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that its global non-interventional, observational multiple myeloma study is now enrolling patients. Titled INSIGHT-MM, the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort to track patterns in disease presentation, patient characteristics, treatment and outcomes and thereby enhance the understanding of real world experience of patients with multiple myeloma.
“As both a physician and a patient, I have seen – and experienced – rapid changes in the approach to multiple myeloma treatment. Even with the recent introduction of new therapies, more work needs to be done to improve outcomes for patients across the globe,” said Jim Omel, M.D., INSIGHT-MM Steering Committee member, who was diagnosed with multiple myeloma in 1997. “The INSIGHT-MM study gives the community an opportunity to work together to better understand how clinical advances affect multiple myeloma patients in the real world.”
“In relatively rare diseases, such as multiple myeloma, we often lack access to large datasets that can help inform decisions in our practices,” said Faith Davies, M.D., Professor of Medicine and Medical Director, Myeloma Institute, University of Arkansas for Medical Sciences, INSIGHT-MM Steering Committee Co-Chair. “By gathering comprehensive real world data on this scale, we will have the opportunity to identify best practices from across the globe to help us better understand what works and what doesn’t for specific patients. These learnings can in turn enhance our efforts to improve disease management for people living with multiple myeloma.”
Study sites at the University of Arkansas for Medical Sciences; the University of California, San Diego; and the University of Cincinnati Cancer Institute – the first three of an anticipated more than 150 global locations – are now active and have enrolled the first patients in the study. Led by an international steering committee of myeloma experts, the INSIGHT-MM study will gather data via routine office visits, medical records and patient self-reported outcomes. Participation in INSIGHT-MM, a non-interventional study, will not determine or alter patients’ treatment; rather, patients will receive their usual therapy as determined by their healthcare provider during the course of their care. Designed to be collaborative, INSIGHT-MM remains open for the multiple myeloma community to propose analyses and request data that has been collected during the study.
“At Takeda Oncology, we have worked with the multiple myeloma community for the benefit of patients for nearly two decades. Given the increased complexity of treatment in recent years, we saw the need to understand treatment patterns and patients’ experiences around the world,” said Liviu Niculescu, Vice President Global and U.S. Medical Affairs, Takeda Oncology. “With patients and multiple myeloma experts, we designed the innovative INSIGHT-MM trial to be an open source of data – large enough to reveal differences and trends globally. We invite collaborations from other similar studies in order to increase the size of available databases and move us closer to a future when robust data on multiple myeloma enables us to change the face of the disease.”
The INSIGHT-MM study is currently enrolling patients in the United States and will soon be enrolling patients globally. The following countries are participating in the INSIGHT-MM study: The United States, the United Kingdom, Germany, Italy, Spain, Brazil, Israel, France, Belgium, Greece, Mexico, China, Taiwan, Colombia and Turkey. To learn more, please visit https://clinicaltrials.gov/show/NCT02761187.
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with approximately 30,000 new cases in the US, 39,000 new cases in the EU and 114,000 new cases globally per year.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/newsroom.
Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website,www.takedaoncology.com.
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