A Perspective, Single Center Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

Study Overview
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Brief Summary
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The investigators designed the present study with the aim of observing the rate of MRD conversion and its impact on survival in primary multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) after tonification therapy and comparing them with the same NDMM patients who obtained MRD negativity after induction and consolidation therapy, and observing the rate of persistent MRD negativity, progression-free survival (PFS), and overall survival in the two groups. progression survival (PFS) and overall survival (OS).

Official Title
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A Perspective, Single Center Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

Conditions
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Multiple Myeloma, Minimal Residual Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or older and gender; Diagnosed with primary multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria, receiving induction and consolidation therapy to achieve partial remission (PR) and above, and MRD-negative, or persistently MRD-positive and agreeing to adjust the treatment regimen; No progression of extramedullary plasmacytoma or new bone destruction and extramedullary plasmacytoma confirmed by whole-body low-dose CT, MRI, or PET-CT after induction and consolidation therapy; Females of childbearing age must have a negative pregnancy test prior to enrollment and agree to use contraception during the study and for 3 months after the last treatment; Subjects and family members agree to participate in the study and sign an informed consent form. Exclusion Criteria: Failure to achieve PR after induction and consolidation therapy; Relapsed multiple myeloma; disagreed to participate in this clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRD negativity<br>NDMM patients who obtained MRD negativity after induction and consolidation therapy | |
| MRD positivity<br>NDMM patients who MRD positivity after induction and consolidation therapy and agree to adjust the treatment regimen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted treatment-adjusted MRD-negative rates | Adjusted treatment-adjusted MRD-negative rates in NDMM patients with persistent MRD positivity after induction and consolidation therapy. In this context, MRD-negativity was defined as bone marrow MRD-negativity confirmed by next-generation flow cytometry (NGF) or next-generation sequencing technology (NGS). | through study completion, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death | through study completion, up to 2 years | 
| Overall Survival (OS) | OS were calculated from the time of enrollment to death or the last follow-up | through study completion, up to 2 years | 
| Persistent MRD-negative rates and survival | Persistent MRD-negative rates and survival (including PFS and OS) in both groups compared to NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy | through study completion, up to 2 years | 
| Treatment related adverse event(TRAE) | Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments. | through study completion, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, MRD-tailored therapy, MRD status, MRD-negative rates, Survival