24-hour Urine Testing Does Not Add Value to Myeloma Response Assessments | Rahul Banerjee | #ASH24

Hi everyone. Welcome to Ash 2024. My name is Rahul Banerjee. I'm an assistant professor of medicine at the Fred Hutchinson Cancer Center in Seattle, Washington, and I just presented an oral abstract this morning about the value of 24 hour urine testing in patients with multiple myeloma for response assessments. Those of you listening to this, maybe you've heard of 24 hour urines.

Maybe you haven't. Because in real world settings, we often don't check them that often. But technically in clinical trials to confirm that someone's in remission, a complete response, or to confirm even a partial response, we've asked patients to do a 24 hour urine assessment, which is exactly what it sounds like. You know, taking your urine, keeping in the fridge every time you have to go to the bathroom, you know, over a 24 hour period collecting the urine into that bucket, into the fridge, into that jug, and bringing it in thereafter.

You can imagine it's very cumbersome for patients. Best case scenario, I think it creates disparities in myeloma. You know, worst case scenario, right? Patients who don't have access to refrigerator patients who work odd jobs. You know, anatomically speaking, it's harder to collect a 24 hour sample for women instead of men. Right? There's a lot of issues with this.

And in the era of serum free light chains and MRD and all these newer tests that have been around for years now, what value is a 24 hour urine testing adding? So what we did was we did a big analysis of a large phase three study. Phase three study is one of the biggest trials in myeloma. It was a BMP, CTN 0702 stamina trial.

And we looked at patients after the first transplant time point. And we calculated the responses two ways, one by the book, by the book, a traditional international myeloma working group. IMWG response criteria currently require a 24 hour urine versus not. We found that if you got rid of the requirement for 24 hour urine, only seven patients out of 600.

So like 1% of patients had a response change, one way or the other. Some patients did better, so to speak, some did worse. Most importantly to me, four of the seven. So more than half of the discrepancies were patients who were non evaluable by traditional criteria who became evaluable. What does that mean? Patients put their blood, soil, sweat and tears into these clinical trials after missing one time point or the urine wasn't collected properly.

They're not evaluable, not included in the results of the trial, which I think is weird and unfair. And so here we found that by eliminating the requirement for urine, these patients who are formerly not evaluable became evaluable. And we found that using these urine free criteria, the different depth of response, a complete response, a very good partial response or partial response or stable disease, we're able to predict how long patients were in remission thereafter.

So in brief, you know, many of you probably don't check 24 hour urines that much outside of clinical trials because your doctor already knows this. Those of you who are on clinical trials, you're very familiar with this because again, trials have to go by the book. The book is changing. I'm part of the International Myeloma Working Group.

And so we're working on this. We know this. And the data that I presented are part of the process to change things. So in the future we will not be requiring 24 hour urine for everyone every time point maybe in a couple of cases, but not for everybody. The one caveat I will add is for any of you who are listening, who have AL amyloidosis, this does not apply. In Al amyloidosis, 24 hour urine assessments are very important, and I use them all the time with my patients. Or I asked for them because they're a very good early barometer of kidney recovery for amyloidosis. In the absence of that, I would say 24 hour urine, their role is going to be very rapidly diminished, deemphasized in the response criteria that are coming out soon.

So stay tuned.