MRD Detection Methods for Multiple Myeloma

Overseen By Andrzej Jakubowiak, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: Lenalidomide, Pomalidomide, Bortezomib, Ixazomib

Disqualifiers: Progressive disease, MRD-positive, Amyloidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether advanced methods can more accurately detect Measurable Residual Disease (MRD) in multiple myeloma patients and determine if those who test negative can safely stop ongoing maintenance therapy during the Discontinuation Phase. The research also investigates whether liquid biopsies (blood tests) could provide a better, less invasive way to monitor the disease. Ideal participants are those who have multiple myeloma, have been on single-agent maintenance therapy for over a year, and have recently tested MRD-negative with a bone marrow test. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could improve future monitoring and treatment strategies.

Will I have to stop taking my current medications?

The trial is for patients who are currently on maintenance therapy for multiple myeloma. If you are MRD-negative, the study aims to see if you can safely stop this maintenance therapy. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.

What prior data suggests that these MRD detection methods are safe for multiple myeloma patients?

Research has shown that new methods for detecting minimal residual disease (MRD) in multiple myeloma are both effective and safe. One study found that when certain treatments render patients MRD-negative, their quality of life and safety improve. Specifically, MRD-negative patients experience less disease progression and generally feel better.

These methods can detect MRD at very low levels, aiding doctors in deciding if patients can safely discontinue ongoing maintenance therapy. Maintenance therapy, given after initial treatment, helps prevent cancer recurrence. This research aims to determine if patients who test negative for MRD can stop their maintenance therapy without complications.

In summary, the new MRD detection techniques are safe and assist doctors in selecting the best treatment plan for their patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on detecting minimal residual disease (MRD) in multiple myeloma, which could revolutionize patient monitoring and treatment decisions. Current treatments often rely on broader assessments of disease progression, but MRD detection offers a more precise evaluation of how much cancer remains after treatment. This method has the potential to significantly improve how doctors decide when to continue or stop treatment, ultimately leading to more personalized and effective care for patients. By refining how we monitor the disease, this trial could pave the way for better outcomes and fewer unnecessary treatments for multiple myeloma patients.

What evidence suggests that these MRD detection methods are effective for multiple myeloma?

Research has shown that reaching a state where no cancer cells can be detected, known as MRD-negative, greatly benefits people with multiple myeloma. Studies have found that MRD-negative patients have an 82% lower risk of cancer progression and an 88% lower risk of death compared to those who are not MRD-negative. This indicates that MRD-negative patients have a much better chance of staying in remission. In this trial, researchers are investigating the MRD2STOP ARM to determine whether MRD-negative patients can safely stop maintenance therapy, as they might not need ongoing treatment to remain healthy. This approach could reduce treatment-related side effects while maintaining effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Andrzej Jakubowiak, MD, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma who've had initial treatment and at least a year of maintenance therapy without signs of active disease. They must be in good health, able to undergo bone marrow tests, and women must use contraception if necessary.

Inclusion Criteria

I agree to use two reliable birth control methods or abstain from sex if I can have children and am on lenalidomide.

I can take care of myself but might not be able to do heavy physical work.

My last PET/CT scan was within 1.5 years and showed no signs of myeloma.

Exclusion Criteria

I have been diagnosed with or suspected to have amyloidosis.

I am not willing to stop my ongoing maintenance therapy.

I have a blood cancer along with my current condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-Transplant Maintenance Therapy

Participants receive maintenance therapy with lenalidomide, pomalidomide, bortezomib, or ixazomib for at least one year

52 weeks

MRD Assessment

Participants are assessed for Measurable Residual Disease (MRD) using novel imaging and laboratory techniques

Ongoing

Follow-up

Participants are monitored for progression-free survival and overall survival after discontinuation of maintenance therapy

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Discontinuation Phase
• Screening Phase

Trial Overview The study aims to see if patients with no measurable residual disease can stop their post-transplant maintenance therapy safely. It uses advanced imaging and lab tests including PET/CT scans, flow cytometry, NGS, and mass spectrometry.

How Is the Trial Designed?

Group I: MRD2STOP ARM Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180695/

Advancing MRD Detection in Multiple Myeloma This paper provides a comprehensive review of recent advancements in major MRD detection methods for MM patients.

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/6952/527197/Impact-of-Minimal-Residual-Disease-Status-on

Impact of Minimal Residual Disease Status on Multiple ... The use of MRD testing can help clinicians predict the efficacy of the treatment regimen and the outcomes for the multiple myeloma patients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10377959/

Minimal Residual Disease in Multiple Myeloma In this context, achieving negative MRD demonstrated an 82% reduction in the risk of progression and 88% reduction in the risk of death, with a survival ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000649712410691X

Evolving Patterns of MRD Testing and First-Line Treatment ... Results: MRD testing among recently treated 1L MM patients increased over time in both settings but was higher in academic practices (48% vs. 41 ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2505133

Measurable Residual Disease–Guided Therapy in Newly ... Among 485 patients who were MRD-negative at 10−5 sensitivity after induction, a premaintenance MRD-negative status at 10−6 sensitivity occurred in 86% in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11215375/

Role of minimal residual disease assessment in multiple ... Novel and highly sensitive methods have been developed allowing the detection of minimal residual disease (MRD) during or after treatment.

7. onclive.com onclive.com/view/d-vrd-produces-favorable-pros-and-safety-outcomes-in-mrd-negative-newly-diagnosed-multiple-myeloma

D-VRd Produces Favorable PROs and Safety Outcomes in ... MRD negativity with D-VRd treatment improves quality of life and safety outcomes in multiple myeloma patients. Higher progression-free survival ...

8. ashpublications.org ashpublications.org/blood/article/146/6/707/536593/Optimal-MRD-based-end-point-to-support-response

Optimal MRD-based end point to support response-adapted ... S-MRD negativity <10–5 is the best predictor of outcomes in newly diagnosed multiple myeloma. Similar results are seen among patients who ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7547

Leveraging AI for validating the association between ... Leveraging AI for validating the association between minimal residual disease (MRD) and survival outcomes in multiple myeloma. · Abstract.