The Horizon 2020 MMpredict initiative was started on November 1st 2016 and included the following consortium partners: SkylineDx, the Department of Haematology of the Erasmus University Medical Centre Rotterdam, the Department of Onco-Haematology of the University of Turin, the Institute for Medical Technology Assessment of the Erasmus University Rotterdam (EUR) and the Myeloma Patients Europe (MPE), combining a small to medium-sized enterprise specialised in molecular diagnostics, two clinical centres with renowned key opinion leaders, a leading health economic institute, and a European Multiple Myeloma patient advocacy organisation. The consortium aims to develop and commercialize a personalised medicine tool that is capable of predicting the most effective treatment strategy for individual Multiple Myeloma patients.
Multiple Myeloma (MM) is an incurable disease of the patients’ plasma cells (PCs), which are specialized white blood cells located within the interior of larger bones. Here, embedded in the bone marrow – they produce and secrete antibodies as part of the immune system, for the neutralization of pathogens. This type of blood cancer is characterized by excessive numbers of abnormal PCs that crowd out remaining, healthy cells. Despite the fact that MM is a very heterogeneous disease it affects the body in several ways resulting in symptoms like anaemia, bone lesions, infections, hypercalcemia, fatigue, and pain. In Europe, each year around 40.000 new MM cases are diagnosed. The disease is treatable, but unfortunately remains currently incurable. In recent years the treatment landscape of MM has evolved considerably, resulting in major improvement of overall survival. Despite the progress, not all individuals seem to benefit equally. Due to large tumour heterogeneity and patient’s intrinsic characteristics, different clinical outcomes are observed within the MM population. Moreover, while MM treatment options are expanding, their efficient implementation remains mainly based on trial-and-error. As a result, patients may receive one or even multiple ineffective treatments before switching to an effective alternative. Since cancer treatments are in general very toxic, this will often be associated with unnecessary serious side effects. For these reasons there is an urgent unmet clinical need for a diagnostic assay that identifies the best treatment option for each individual patient.
Previously, SkylineDx developed and validated an in vitro diagnostic medical device - the MMprofilerTM - which can subtype and reliably predict survival of MM patients on the basis of their own gene signature SKY92. This commercially available test can help in the patient management setting by distinguishing high-risk from standard-risk disease. However, the ability to predict the most effective treatment will greatly expand the clinical value, relevance and utility of such a test. In this project we aim to develop a product, which can help physicians in their treatment decision-making and leading to a personalised medicine strategy that optimizes therapy selection to improve outcome and to minimize treatment related side effects.
