Press Release | The Hague, 5 December 2019
New data presented by the HARMONY Alliance validate the current prognostic tool for Multiple Myeloma and have identified new parameters to improve the staging of the disease. Oncologists can use this tool – the Revised International Staging System – to predict the prognosis and subsequently identify the best treatment for patients with Multiple Myeloma. The data will be presented during the poster viewing session at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
Multiple Myeloma (MM) is the second most common hematologic malignancy (blood cancer) in Europe. It is a malignancy of plasma cells (a type of white blood cell) that typically affects multiple sites within the bone marrow, resulting in bone pain, anemia, frequent infections, and kidney failure. MM can remain asymptomatic for a long time and can reach an advanced stage at the time of diagnosis. Despite recent advances in the treatment of MM, many patients eventually relapse, and the disease remains largely incurable.
One of the unmet clinical needs in MM management is a validated and reliable prognostic tool that can be used routinely in clinical practice. The clinical outcome of MM is heterogeneous, with patients’ survival times ranging from a few months to more than ten years. A better definition of prognostic subgroups is essential to provide more effective personalized therapies.
Several European cooperative research groups have collected data through the European Myeloma Network and submitted the data to the HARMONY Big Data Platform. This Platform currently contains anonymized data records from 5,584 newly diagnosed patients with MM who were enrolled in 14 clinical trials. Of these patients, 26% had stage I disease (i.e. good prognosis), 64% stage II (intermediate prognosis), and 10% stage III (poor prognosis). Ten-year overall survival rates for these groups were 60%, 33%, and 13%, respectively.
Mattia D'Agostino, University of Turin:
“Our data confirm the prognostic value of the Revised International Staging System in the largest cohort of newly diagnosed patients with MM analyzed so far, and also in subgroups of patients such as those who are transplant-eligible and transplant-ineligible; and patients treated with proteasome inhibitors, immunomodulatory agents, or both. In addition, we have identified other independent overall survival predictors that may be used to improve the Revised International Staging System.”
Ananda Plate, Chief Executive Officer of Myeloma Patients Europe (MPE):
“Improving scientific understanding of the stage, prognosis, and risk profile of Multiple Myeloma is extremely important for patients, as it can enable better informed decisions about the most appropriate treatment options and ultimately lead to better survival outcomes. The confirmation of the applicability of Revised International Staging System and the additional overall survival predictors identified through the HARMONY project are crucial for patients and demonstrate the value of Big Data in driving improvements in patient outcomes.”
In the future, the researchers plan to add new datasets to validate these additional parameters. The improvement of the Revised International Staging System may foster a worldwide collaboration. As a next step, the researchers will compare different therapeutic approaches in the three prognostic subgroups identified in the analysis, with the aim of determining the optimal treatment for individual patients.
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Public-private partnership for Big Data in Hematology
HARMONY and HARMONY PLUS are funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding is received from the IMI 2 Joint Undertaking and is listed under grant agreement for HARMONY No. 116026 and grant agreement for HARMONY PLUS No. 945406. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
HARMONY Coordination Office
Institute of Biomedical Research of
Salamanca (IBSAL)
Salamanca, Spain
HARMONY Communications
European Hematology Association (EHA)
The Hague, The Netherlands
