In late Augustus 2016 Takeda Oncology announced that the INSIGHT-MM, the company’s global non-interventional, observational multiple myeloma study, is now enrolling patients. 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.
Multiple myeloma is a relatively rare form of cancer, with, according to the American Cancer Society, approximately 30,000 new cases in the United States, 39,000 new cases in the European Union and approximately 114,000 new cases globally per year.
The disease 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.
Overall, the care of patients with multiple myeloma is complex. Generally, protocols emphasize that care should focus on treatment of the disease process and any associated complication. Although several drug therapies as well as autologous stem cell transplantation, radiation, and, in certain cases, surgery are valuable in the treatment of patients with multiple myeloma, the disease remains incurable.
Much work is being done in the development of novel treatment options. But even with the recent introduction of new therapies, as well as novel therapeutic options in clinical trials, more work needs to be done to improve outcomes for patients across the globe.
Integrating patient insights
Scientists and researchers at Takeda have pioneered the practice of integrating patient insights into clinical trial protocols sponsored by the company. The INSIGHT-MM study gives the community of scientists, researchers, doctors and patients an opportunity to work together to better understand how clinical advances affect multiple myeloma patients in the real world. This approach has helped them develop medicines that truly make a difference for patients.
Understanding multiple myeloma
Earlier this month we spoke with Liviu Niculescu, Vice President, Global and U.S. Oncology Medical Affairs, Takeda Oncology.
Question: I noticed that there is not a direct link to a specific therapy. Is that correct or did I miss something here?
Answer: That is correct. This is a disease study, not a drug study. INSIGHT-MM is a global non-interventional, observational study. Participation in INSIGHT-MM 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. No study drug or medications will be provided, and no change will be required in the patients’ management (routine clinical care or treatments) as a result of this study.
Q: Other than observing patients and learning about disease progression, treatment etc., what is the rationale?
A: The only rationale is to advance the understanding of the disease and treatment patterns, so we can further advance the care for patients with this cancer. Currently, only a fraction of patients is enrolled in clinical trials (observational or interventional), so our data are limited. The treatment approaches to multiple myeloma are changing rapidly, with the introduction of new treatments that have demonstrated an impact on survival. Despite recent clinical advances in multiple myeloma treatment, many questions remain unanswered, and there is a need for real-world data on global patterns in disease presentation, patient characteristics, treatment and outcomes for patients with multiple myeloma.
Over the course of the INSIGHT-MM study, information will be recorded based on review of hospital or clinic records. Multiple myeloma management data and safety data will be obtained as part of routine office visits. Patients will complete health-related quality of life and patient self-reported outcomes surveys at inclusion and at predefined intervals throughout the study, and this information will be collected using a secure electronic data collection system (technical devices and/or paper survey forms will be provided for patients who cannot access the internet).
Q: How does Takeda benefit from this study, why is this important and how do (future) patients benefit from this?
A: The benefits of INSIGHT-MM for Takeda Oncology and the benefits for patients are the same – greater knowledge that may facilitate better outcomes. By gathering comprehensive real world data on this scale, we hope to identify best practices across the globe and gather important insights with the aim of advancing care for patients with multiple myeloma and help guide future clinical research direction. Patients who participate in INSIGHT-MM will have the opportunity to help increase global understanding of how multiple myeloma and its treatment affect people in the real world.
These learnings can in turn enhance our efforts to improve disease management for people living with multiple myeloma.
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.
Participation and study locations
The INSIGHT-MM trial will be conducted on a global scale. The first 3 study sites of more than 150 anticipated global sites are at University of Arkansas for Medical Sciences, the University of California, San Diego; and the University of Cincinnati Cancer Institute.
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.
Last Editorial Review: September 9, 2016
Photo: Liviu Niculescu, Vice President, Global and U.S. Oncology Medical Affairs, Takeda Oncology. Courtesy: © Takeda Oncology. Used with permission.
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