An observational study in Multiple Myeloma, sponsored by Mario Boccadoro. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Mario Boccadoro · Observational
The consortium aims to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients. MM is the second most common form of blood cancer contributing to 15% of all blood cancers and \~1,5% and 2% of all cancer deaths annually in the EU and US, respectively.
Patients show a large variability in treatment response and side effects due to tumour heterogeneity and the patient's intrinsic characteristics. Therefore, not every treatment will be suitable for each patient, and treatment strategies are often based on trial-and-error. The availability of multiple (>20) treatment options complicates treatment decision-making even more. With the current development of many more promising treatments, there is an urgent unmet clinical need for a diagnostic assay that supports personalised cancer treatment in order to improve patient health outcomes, prevent side effects and reduce healthcare costs.
SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling. An addendum for new intended use will be filed to the current in vitro diagnostic (IVD) registration, while renaming the test to MMpredictor. The project will also focus on positioning the test as a cost-effective IVD test for personalised medicine, that will increase health outcome and quality of life of patients and reduce healthcare costs.
The consortium consists of a life science SME specialised in molecular diagnostics, clinical centres with world renowned KOLs, a leading health economic institute, and a European MM patient advocacy organisation combining all the required complementary expertise to successfully bring the MMpredictor to market.
MM patients enrolled in clinical trials that have been conducted over the past 5 years.
Exclusion Criteria:
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SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling.
MMpredictor as a personalised medicine tool
The main objective of the MMpredict project is to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients.
Time frame: 1 year
- Genetic subtyping with the MMprofiler of 800 bio-banked MM patient samples
Time frame: 2 years
- Clinical validation of genetic subtypes correlating with specific treatment effect
Time frame: 2 years
- Establish a treatment decision matrix that will guide physicians in treatment decision-making
Time frame: 2 years
- Perform a Medical Technology Assessment (MTA) to evaluate health economic benefits
Time frame: 2 years
- File addendum to current CE-IVD registration, while also renaming the test to "MMpredictor"
Time frame: 2 years
- Develop and execute commercialisation and marketing plan for the MMpredictor
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Mario Boccadoro