MRD Detection Methods for Multiple Myeloma

Overseen By Andrzej Jakubowiak, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

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

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to assess for Measurable Residual Disease (MRD) in multiple myeloma at a deeper level than what is currently available by combining novel imaging and laboratory techniques, determine if patients who are MRD-negative by these multiple modalities can safely and effectively discontinue post-transplant maintenance therapy, and determine if liquid biopsies is a more accurate and/or less invasive sampling technique for multiple myeloma. The purpose of this research is to determine if patients who are MRD-negative by multiple modalities ("multimodality MRD-negative") can safely and effectively discontinue post-transplant maintenance therapy (single agent lenalidomide, pomalidomide, bortezomib, or ixazomib) after receiving at least one year of maintenance therapy.

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 data supports the effectiveness of this treatment for multiple myeloma?

Research shows that achieving minimal residual disease (MRD) negativity in multiple myeloma patients is linked to better survival outcomes. MRD negativity, detected through advanced methods like next generation sequencing, is a strong indicator of longer time before needing the next treatment. ^{1 2 3 4 5}

Is MRD detection for multiple myeloma safe for humans?

The research articles provided do not contain specific safety data regarding MRD detection methods for multiple myeloma. They focus on the effectiveness and implementation of MRD testing in clinical trials and practice. ^{1 6 7 8 9}

How does the MRD detection treatment for multiple myeloma differ from other treatments?

The MRD detection treatment for multiple myeloma is unique because it uses advanced techniques like next-generation sequencing and flow cytometry to detect minimal residual disease, which helps in accurately assessing the effectiveness of treatments and guiding future therapy decisions. This approach is more sensitive than traditional methods and can identify small amounts of remaining cancer cells that might lead to relapse. ^{1 10 11 12 13}

Research Team

Andrzej Jakubowiak, MD, PhD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Determination of Minimal Residual Disease in Multiple Myeloma: Does It Matter? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Minimal Residual Disease Predicts Outcome at Two Time Points in Myeloma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Integrated analysis of next generation sequencing minimal residual disease (MRD) and PET scan in transplant eligible myeloma patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Minimal residual disease in multiple myeloma: defining the role of next generation sequencing and flow cytometry in routine diagnostic use. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Flow cytometry quality requirements for monitoring of minimal disease in plasma cell myeloma. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

MRD Testing in Multiple Myeloma: From a Surrogate Marker of Clinical Outcomes to an Every-Day Clinical Tool. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

MRD detection in multiple myeloma: comparison between MSKCC 10-color single-tube and EuroFlow 8-color 2-tube methods. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Utility of Euroflow MRD Assessment in Real-World Multiple Myeloma Practice. [2022]

9. England pubmed.ncbi.nlm.nih.gov

International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Minimal Residual Disease in Multiple Myeloma: Impact on Response Assessment, Prognosis and Tumor Heterogeneity. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Minimal Residual Disease in Multiple Myeloma: State of the Art and Future Perspectives. [2023]

12. China pubmed.ncbi.nlm.nih.gov

[Clinical Significance and Detection Techniques of Minimal Residual Disease in Multiple Myeloma-Review]. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Single-Tube 10-Fluorochrome Analysis for Efficient Flow Cytometric Evaluation of Minimal Residual Disease in Plasma Cell Myeloma. [2020]