Study to Assess for Measurable Residual Disease (MRD) in Multiple Myeloma Patients
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|ClinicalTrials.gov Identifier: NCT04108624|
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : January 12, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Other: Screening Phase Device: Discontinuation Phase||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multimodality Approach to Minimal Residual Disease Detection to Guide Post-Transplant Maintenance Therapy in Multiple Myeloma (MRD2STOP)|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2024|
|Experimental: MRD2STOP ARM||
Other: Screening Phase
This will identify subjects who are MRD (minimal residual disease) negative and eligible for the discontinuation phase.
Device: Discontinuation Phase
Patients will undergo discontinuation of their maintenance therapy if they are MRD negative by PET/CT (Positron Emission Tomography/Computed Tomography), flow cytometry and next generation sequencing
- Determine the MRD conversion rate [ Time Frame: 3 years ]Determine the MRD conversion rate from 1 in 1,000,000 cells and 1 in 10,000,000 cells negative to positive after discontinuation of maintenance therapy.
- Median Progression Free Survival rate [ Time Frame: 3 years ]Assess progression free survival of double MRD-negative (1 in 1,000,000 cells negative/1 in 10,000,000 cells negative) patients and of the 1 in 1,000,000 cells negative/1 in 10,000,000 cells positive patients who have discontinued maintenance therapy
- Median overall survival rate [ Time Frame: 3 years ]Assess overall survival of double MRD-negative (1 in 1,000,000 cells negative/1 in 10,000,000 cells negative) patients and of the 1 in 1,000,000 cells negative/1 in 10,000,000 cells positive patients who have discontinued maintenance therapy.
- NGS-based Minimal Residual Disease testing determined by the ClonoSeq assay [ Time Frame: 3 years ]Determine the feasibility of performing NGS-based MRD testing of bone marrow aspirate samples that have undergone CD138+ immunomagnetic cell separation (i.e. 1 in 10,000,000 cells depth) will be determined by the rate of achieving 20 million cells in raw aspirate sample with a sufficient DNA for analysis as determined by the ClonoSeq assay.
- Determine the difference in MRD detection by NGS [ Time Frame: 3 years ]Determine the difference in MRD detection by NGS in the bone marrow at depths of 1 in 1,000,000 cells and 1 in 10,000,000 cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108624
|Contact: Andrzej Jakubowiak, MDemail@example.com|
|United States, Illinois|
|University Of Chicago Medicine Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Amanda McIver 773-834-5884 firstname.lastname@example.org|
|Principal Investigator: Andrzej Jakubowiak, MD|
|Principal Investigator:||Andrzej Jakubowiak, MD||University of Chicago|