Traditionally, when testing new myeloma treatments, researchers need to wait many months or even years to determine if a treatment is working. They look at how long patients live without their disease getting worse (progression-free survival) and how long they will live regardless of the disease (overall survival).

MRD testing is transforming this approach. By detecting even tiny amounts of remaining myeloma cells, MRD testing can show much sooner whether a treatment is working effectively, and therefore, predict long-term outcomes like progression-free survival (PFS) and overall survival (OS). This is what is known as a surrogate marker.

Research has consistently shown that patients who achieve MRD negativity typically have better long-term outcomes, including longer survival times and lower chances of relapse. The FDA recognizes the value of MRD testing and has already used MRD data to grant faster approvals for some new myeloma treatments. 

Experts at the FDA are currently evaluating its potential to become a primary clinical trial endpoint, but as of early 2025, no conclusion has been reached. However, it serves as an important tool for evaluating how well treatments work.

To review the clinical trials that have shaped how MRD is currently used in myeloma care, read the article below: 

The Clinical Trials That Have Shaped MRD