Welcome! We’re here to recap the latest news in Minimal Residual Disease (MRD) status from the Myeloma MRD 2025 Meeting that kicked off Friday, April 11, at the Sylvester Comprehensive Cancer Center in Miami. The MMRF has been part of this meeting since its inception, participating in a number of panels, presentations, and thoughtful discussions along with clinicians, researchers, companies, advocates, patients, and caregivers on the state of MRD testing.
MRD is an important part of monitoring myeloma after treatment. It measures how many cancer cells are still in the bone marrow. If someone is MRD-negative, it means the number of cancer cells is so small that that they are nearly undetectable.
Here are the major takeaway points from the MRD Meeting:
Let’s take a closer look!
Reaching MRD negativity can be good news for patients, and many clinical trials showed that sustained MRD negativity is closely tied with favorable outcomes.
However, there are several important points we have to remember. For one, these studies and others showed that MRD negativity could be reached no matter what treatment patients were on. For example, studies that compared triplet versus quadruplet myeloma therapies both showed a significant amount of patients reaching MRD negativity.
Secondly, patients may never achieve MRD negativity but still have favorable outcomes. For example, people with monoclonal gammopathy of undetermined significance (MGUS) have a higher number of plasma cells and are not MRD negative. Yet, they rarely progress to myeloma. Some myeloma patients who are very good partial responders or complete responders and have clearly detectable MRD can also stay in remission for a long time.
Lastly, being MRD negative shouldn’t be confused with being cured. In several studies, we saw that patients who were MRD negative could still relapse to being MRD positive over time.
Taken together, these examples show that MRD status is only one piece of a larger puzzle.
To fully understand a patient’s prognosis and make the best treatment decisions, their care team looks at more than just MRD status. They also consider genetic changes in their myeloma, how many treatments they’ve had before, and how well their body handles those treatments. Also, more research is still needed to figure out how well patients will do if they do not reach MRD negativity, and why some MRD negative patients relapse.
For all these reasons, the use of MRD data to inform decisions for individual patients is still an area of active research.
One discussion in Miami centered around the FDA Oncologic Drugs Advisory Committee (ODAC) agreement that MRD status could be used as an intermediate endpoint in clinical trials. But what does this actually mean for patients?
For new myeloma treatments to be approved, clinical trials must first reach what are called primary endpoints. These are outcomes that can tell if the new treatment was effective or not. Many myeloma therapies rely on primary endpoints like progression free survival (PFS), or overall survival (OS). While these endpoints tell us a lot , they can take a long time to determine if a treatment is effective and safe.
Fortunately the FDA has been open to reducing that time by using an endpoint that could predict PFS. Now, MRD data has come into play because the latest clinical evidence shows that MRD can be a useful tool for predicting if a clinical trial will show a PFS benefit. And the MRD data for a clinical trial can be available years before the PFS data.
Tying this back to the ODAC in 2024, this group recommended that MRD data be considered an intermediate endpoint that the FDA could use to allow a biopharmaceutical company to market a new treatment while PFS and OS continue to be collected. This could help bring new myeloma treatment options to patients because clinical trials reach the MRD endpoint more quickly.
Given the emerging use of MRD data in clinical trials, it is even more important to understand safety and PFS in order to know what is best for patients.
The good news about MRD testing? It can be reimbursed, it is part of the National Comprehensive Cancer Network (NCCN) guidelines for measuring a response to treatment, and it is available at academic medical centers across the country.
The bad news? It is not widely available in the community, for a variety of reasons.
Finding out MRD status takes time. Not only does a patient need to have a bone marrow biopsy, but that sample must be taken to a lab where very sensitive tests are performed to figure out how many myeloma cells they have. This entire procedure may not be available to everyone –financial, transportation, and other logistical barriers are in the way for patients, and community providers may not have the resources needed to perform MRD testing.
Could this all change?
During the end of the workshop, presenters discussed new, innovative ways to make MRD testing easier and more accessible. Many of the techniques discussed looked to bypass the need for a bone marrow biopsy, and instead, figure out the number of myeloma cells using DNA or protein collected strictly from blood samples.
Why is this important?
Improved availability and lowering logistical barriers for patients and providers could pave the way for frequent MRD testing. This could improve the prognostic information for patients and doctors, and spur on more research to optimize the use of MRD in trials and for patients.
