ASH 2025 | The PROMISE study: screening over 30,000 individuals for monoclonal gammopathies

We presented our new results from the PROMISE study yesterday. So the PROMISE study initially started in 2019 and we have now grown through international collaborations in Greece, Israel and South Africa and through also national collaborations with biobanks like the Mass General Brigham Biobanks and the PLCO Biobank and with that we have now screened more than 33,000 individuals in the PROMISE study. So initially the PROMISE study wanted to address the gap in between screening and focusing on screening of high-risk individuals. So we mostly know myeloma as a disease of the elderly. However, pre-malignant changes happened decades before, and so different screening studies started to try to use the opportunity to screen, detect, and intercept earlier the disease, especially with the new advancement in treatment and daratumumab being approved earlier in the treatment. So previous studies have started screening and found using SPEP a prevalence of around 3-5% in the general population, and it’s mainly the Olmsted County study from Mayo Clinic, the Icelandic study. However, mostly the population is homogenous, so we also know from different smaller studies that the prevalence in individuals who are African American or who have a first degree relative with hematological malignancies have higher prevalence of the disease. 

So the PROMISE study addresses specifically that, looking at these high-risk populations to make screening more practical and to find who will benefit most from this screening. So we use the MALDI-TOF mass spectrometry as a method for screening which is highly sensitive and specific and we were able to detect much higher prevalence in individuals who are African-American, around 14% in this group. We were able also to compare to a sample of the general population using also mass spectrometry. It was higher than what was found before, so it was around 10% in individuals above age 40. We also looked at risk factors that were contributing to this increased prevalence and we found race being African-American increased the odds by around 40 percent of having monoclonal gammopathy. We found that a first degree relative with specifically myeloma would increase the odds but we also looked at first-degree relatives with myeloma and other cancers and here the odds were attenuated a little bit. However, having multiple relatives with the disease would increase the odds to five folds of having monoclonal gammopathy. 

So with this, we confirmed that these two groups have an increased prevalence of the disease, and then we looked at the monoclonal gammopathy features, and we found that they also have higher median concentration of the M-protein, which was also linked with an estimated higher smoldering myeloma prevalence, as well as an increased progression as compared to controls. So we hope that this study, along with other studies, will be able to help us really identify who will benefit most from screening, when to start and what to use for the screening. So yeah, a lot of promising things coming.

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