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

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–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 US 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 https://www.takeda.com/news.
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.