In the present analysis we included over 10,000 patients with newly diagnosed multiple myeloma from 16 international clinical trials with a median follow-up of more than 70 months. And this was all done within the European Myeloma Network and the HARMONY analysis. The aim of this analysis was to identify patients with a functional high-risk disease, which is characterized by an early relapse of multiple myeloma within the first 18 months from the randomization within the trials...
In the present analysis we included over 10,000 patients with newly diagnosed multiple myeloma from 16 international clinical trials with a median follow-up of more than 70 months. And this was all done within the European Myeloma Network and the HARMONY analysis. The aim of this analysis was to identify patients with a functional high-risk disease, which is characterized by an early relapse of multiple myeloma within the first 18 months from the randomization within the trials. So first we could show that this is an independent prognostic factor. And it was even in multivariable analysis, it was among the strongest prognostic factors for outcome. And these patients had a very, very short overall survival of only 40%, roughly 40% at three years. So this confirmed the fact that early relapse within 18 months is considered a real high-risk variable, which is only somehow connected to other disease-related factors. So we then moved on and looked at the disease-related factors like the ISS stage, the LDH values, and the cytogenetics. And we found that patients with early relapse more often have a high tumor burden as reflected by high ISS stages, that they also have more times an elevated LDH and that they also have more common high-risk cytogenetic features. We then moved on and found out if patients carry several of these high-risk features, they are very, very likely to have an early relapse. And in patients who carry all of these adverse prognostic factors, they have a risk for early relapse within 18 months of 50% or more. Finally, we looked at the overall survival outcome of patients with an early relapse and these additional disease-related factors. And what we could see is that there is a further stratification of patients with early relapse based on the disease characteristics that they have at baseline like high ISS and elevated LDH and high-risk cytogenetics. To date, this is one of the largest analyses investigating early relapse in multiple myeloma patients at the first diagnosis and we think that this will help to identify true functionally high-risk patients and tailor the treatment for these patients because there is a large unmet medical need.
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