ASH 2024 | 24-hour urine testing does not add value to multiple myeloma response assessments

So I’m here at the ASH meeting and I’ve just presented this morning actually our oral abstract about 24-hour urine requirements in multiple myeloma response assessments. In brief, many of you are aware, 24-hour urine collections are required as part of IMWG response criteria for myeloma and they’re very cumbersome for patients, right? Collecting your urine over every void over a 24-hour period and keeping it in the fridge is one, you know, anatomically difficult for older adults, particularly for older women. Two, I think it can create disparities for patients without access to refrigeration or have odd work hours. And three, for clinical trials, it’s the bane of everyone’s existence because patients aren’t able to turn it in on time or the sample is not kept at a refrigerated temperature and all of a sudden there’s a problem with it and they have to repeat it. And so we went and decided to look systematically at what if we just got rid of urine? So what if we did a response criteria version that did not require urine testing to achieve a partial response, a very good partial response, a complete response to CR? What we did was we looked at data from the BMT-CTN0702 study, which was a large phase three randomized trial of different post-transplant strategies in myeloma, and we looked at the day plus 100 time point, the first time point after transplant. We calculated both with traditional response criteria and with these urine-free criteria that I’m alluding to. And in brief, there’s only a 1% discrepancy between traditional and urine-free criteria. Seven cases out of over 600 patients analyzed. Importantly, you know, some patients went in either direction. There were some patients who had, for example, a VGPR by traditional criteria who became a urine-free CR, and some went the other direction. Half of the cases were patients who were non-evaluable who became evaluable about their response, if you get rid of the urine, now we can actually use their results to see how they did and what happens thereafter. And in brief, and you’ll see in the abstract, that urine-free response criteria are very prognostic, unsurprisingly. So the depth of someone’s response after transplant, CR, VGPR, PR, or stable disease, you could see on the curves how their subsequent PFS was. And so I’m a member of the International Myeloma Working Group, we are working on updating our response criteria hopefully the next year or so. And based on these and other studies, the role of urine will be heavily deemphasized for patients. And I hope to see a future where urine is only used in rare scenarios like AL amyloidosis and that setting, urine is absolutely essential as part of renal response assessments. But outside of that or scenarios where the only measurable disease is urine, I would love to see less urine in patient refrigerators around the world, less urine deviations in all of our clinical trial protocols, and overall an easier landscape for our patients in general.

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