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|Takeda Launches Largest Pharmaceutical Company-Sponsored Global Observational Study of Its Kind in Multiple Myeloma|
| 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
About Takeda Pharmaceutical Company
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.