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MRD in Myeloma
MRD in Myeloma is an important diagnostic marker. Minimal Residual Disease (MRD) means five MM cells per one million normal cells. To undergo therapy and reach MRD status means that the MM patient has responded well to their therapy killing all but a tiny number of MM cells.
“It shows that there is a very tight correlation between MRD and clinical outcome both in newly diagnosed and in relapsed patients,” said Dr. Landgren…
Dr. Landgren, a knowledgeable MM specialist, is correct. There is a tight correlation between MRD and overall survival. But there is more to managing MM than reaching MRD. I will use an analogy to try to explain my point.
Like a hitting a homerun in a baseball game, reaching MRD status is great. But one or more homeruns doesn’t always mean that you will win the game. I don’t know the stats but there is probably a tight correlation between homeruns and winning games.
But hitting a homerun is not a guarantee of winning the game. The other team may overwhelm your team in a number of ways. Likewise, your MM might overwhelm you.
Why is MRD an important diagnostic marker for myeloma patients?
- Predictive of Long-Term Outcomes: MRD status is a powerful predictor of progression-free survival (PFS) and overall survival (OS) in myeloma patients. Studies have shown that patients who achieve MRD negativity have significantly better long-term outcomes compared to those who remain MRD positive, regardless of the treatment regimen.
- Assessment of Treatment Efficacy: MRD allows for a more precise evaluation of the effectiveness of treatment. Traditional response criteria based on imaging and serum markers may not detect small numbers of residual myeloma cells, whereas MRD assessment can identify even minimal disease presence, guiding further treatment decisions.
- Tailoring Treatment Strategies: By monitoring MRD, clinicians can tailor treatment strategies more effectively. For instance, if a patient remains MRD positive after initial therapy, this may prompt a change in treatment approach, such as intensification or switching to a different therapy. Conversely, MRD negativity might support a decision to reduce treatment intensity, thereby minimizing side effects.
- Early Detection of Relapse: MRD monitoring can provide early detection of relapse before it becomes clinically apparent. This allows for timely intervention, potentially preventing or delaying clinical relapse and improving patient outcomes.
- Standardization and Comparability: MRD assessment provides a standardized and objective measure to compare the efficacy of different treatment regimens across clinical trials and real-world settings. This helps in advancing the field by identifying the most effective therapies and treatment combinations.
- Regulatory and Clinical Trial Endpoints: MRD is increasingly recognized by regulatory bodies as a valuable endpoint in clinical trials. It provides a surrogate marker for long-term clinical outcomes, facilitating the approval of new therapies and improving clinical trial design.
What Dr. Landgren does not discuss is how much toxicity is needed to reach MRD status. I believe that approximately 20% of NDMM patients reach MRD status after their induction therapy. I would say that this group of MRD patients has the best chance for reaching a long OS.
But not reaching MRD status does not mean that the NDMM patient will not live a long OS. In his 2023 study of newly diagnosed MM patients, Dr. James Berenson, following a low dose approach to MM treatment, achieved an average OS of over 11 years for 161 patients.
No autologous stem cell transplantation for any NDMM patient means less toxicity which may mean few if any MRD status patients. Yet the average OS was over 11 years. My guess is that Dr. Landgren and Dr. Berenson view MM treatment differently.
Please don’t misunderstand me. I believe that Dr. Landgren is talking the FDA into acknowledging that there is no cure for MM and that “potentially curative” MM treatment is too aggressive. MRD as an endpoint is significant. I’m simply saying that reaching MRD is not more important than managing the patient’s toxicity.
Are you a newly diagnosed myeloma patient? If you would like to learn more about both conventional and evidence-based non-conventional MM therapies, email me at David.PeopleBeatingCancer@gmail.com
Thank you,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Significant Published Analysis Supports New “MRD” Endpoint for Multiple Myeloma
“A key committee at the U.S. Food and Drug Administration voted in April to allow a new way to evaluate drugs for multiple myeloma. The method uses an endpoint called minimal residual disease (MRD) that promises to accelerate the development of new therapies.
The unanimous 12-0 committee decision was based in large part on an analysis spearheaded by C. Ola Landgren, M.D., Ph.D., director of the Myeloma Research Institute at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine.
On May 20, the journal Blood published Dr. Landgren’s study, a deep meta-analysis of 12 phase 2 or phase 3 clinical trials.
“It shows that there is a very tight correlation between MRD and clinical outcome both in newly diagnosed and in relapsed patients,” said Dr. Landgren…
Accelerated Drug Approval
If adopted by the FDA, the committee’s recommendations will be “amazing” for patients, said Dr. Landgren. The new endpoint will enable drug approval through a special, accelerated pathway based on MRD and shave years off the process. Final, full approval would depend on longer-term data evaluating clinical outcomes like overall survival.
The FDA typically adopts its committee recommendations. A decision may come within weeks.
“It will be like switching from steam engines to jet planes,” said Dr. Landgren…
The Long Road
The new study is called the EVIDENCE meta-analysis, shorthand for “evaluating minimal residual disease as an intermediate clinical endpoint for multiple myeloma.” Its origins began at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), where Dr. Landgren was an investigator in 2009. New treatments were just coming onboard then.
“With the drugs we had at the NIH, we could achieve very deep responses in a very high proportion of patients,” he said. “And I was thinking, ‘If this continues, we will eventually have deep responses in the majority of patients. And it’s going to be very hard to develop drugs…’”
The need is huge. Despite recent therapeutic advances, 40% of patients with multiple myeloma,the second most common type of leukemia, die within five years.”