Does 24-Hour Urine Testing Add Value to Myeloma Response Results?

Understanding the 24-Hour Urine Test

Have you heard of a 24-hour urine test? Though not often used in the real world, these tests are commonly used to confirm a complete or partial response in clinical trials. 

24-hour urine assessments are exactly what they sound like. Patients are given a large jug into which they pour each of their urine samples over a 24-hour period. Most patients express disdain for this type of test, many even admitting they would rather receive a bone marrow biopsy than have to perform a 24-hour urine sample test. 

Disadvantages of the 24-Hour Urine Sample 

The test is not only very cumbersome for patients but also highlights disparities, such as biological sex (it is easier for men to collect samples than women), job position (those with active, on-your-feet jobs are less likely to be able to collect samples in this way), and housing access (limited or no access to a fridge to store the container). 

In the era of serum-free light chains, MRD assessments, and newer tests that have now been around for years, the question remains: what added value (if any) does the 24-hour urine sample have when confirming response results? 

Putting It to the Test 

Dr. Rahul Banerjee and other members of his team wanted to research this question. Dr. Banerjee has long been a proponent of making people’s lives easier, especially those diagnosed with multiple myeloma, so this type of study was a no-brainer. 

They performed an in-depth analysis of a large Phase III (3) study called BMT CTN 0702 Stamina. As part of the analysis, they looked at patients who have the first transplant time point, and they calculated the responses in two ways: 

1. By the book- including the 24-hour urine sample (following current IMWG guidelines)
2. Without the urine test (urine-free responses)

Study Results 

Dr. Banerjee and his team found that if the requirement of 24-hour urine samples were eliminated, only seven patients out of 600 had their response rates changed. That’s about 1.1% of patients. 

Importantly, removing the requirement for the 24-hour urine assessment meant that four of the seven patients whose results had initially been excluded became "evaluable." Previously, issues with their urine samples had disqualified their data from being counted in the clinical trial outcomes—a situation Dr. Banerjee described as weird and unfair.

By allowing urine-free results, these four patients, who had invested their blood, sweat, and tears into the trial, finally saw their efforts recognized in the final clinical trial results.

Future Directions 

With these new clinical trial results, the International Myeloma Working Group (IMWG) is open to updating the guidelines, potentially making 24-hour urine samples obsolete for the general clinical trial population. Of course, it will still be appropriate for some patients, such as those with AL amyloidosis, as 24-hour urine assessments detect kidney recovery in this population much quicker than any other test; however, for most patients, response assessments could be urine-free. 

Patient Perspective 

Myeloma patient and HealthTree Coach, Don Bathurst, shares his opinion on the subject: 

I found this study very interesting, as it could significantly improve patient quality of life. Collecting this sample typically requires staying home all day, collecting at night, figuring out how to store it properly (I use a styrofoam cooler that fits the jug and ice pack perfectly), and then lugging it to the lab the next day. If this step doesn’t add value, it’s something that can be eliminated to streamline the process and focus on what truly enhances treatment.

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