Actively Recruiting
A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment
Led by FengYan Jin · Updated on 2024-07-05
80
Participants Needed
1
Research Sites
208 weeks
Total Duration
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AI-Summary
What this Trial Is About
The aim of this study was to observe the rate of MRD conversion and the impact on survival in newly diagnosed multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) who were switched to high-intensity therapy, and to compare the rate of persistent MRD-negativity, progression-free survival (PFS), and overall survival (OS) between the two groups in comparison with NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy.
CONDITIONS
Official Title
A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with newly diagnosed symptomatic multiple myeloma as defined by 2014 International Myeloma Working Group criteria
- Achieved a partial response or better to at least one prior treatment regimen
- Women of childbearing potential must use two reliable birth control methods or abstain from heterosexual intercourse starting 4 weeks before dosing until 3 months after last dose
- Negative pregnancy test within 14 days before randomization for women of childbearing potential
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
- Relapsed and refractory myeloma defined as disease nonresponsive during salvage therapy or progressing within 60 days after last therapy following minimal response or better
- Primary refractory myeloma defined as disease nonresponsive in patients never achieving minimal response or better
- Unable to comply with study protocol or any condition that could prevent or confound study assessments in investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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