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

Sponsor

FengYan Jin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06109233

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Minimal Residual Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Nov 2, 2025

Anticipated Study Completion Date :

Nov 2, 2026

Arms and Interventions

Arm	Intervention/Treatment
MRD negativity NDMM patients who obtained MRD negativity after induction and consolidation therapy
MRD positivity NDMM patients who MRD positivity after induction and consolidation therapy and agree to adjust the treatment regimen

Outcome Measures

Primary Outcome Measures

Adjusted treatment-adjusted MRD-negative rates [through study completion, up to 2 years]
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).

Secondary Outcome Measures

Progression-Free Survival (PFS) [through study completion, up to 2 years]
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Overall Survival (OS) [through study completion, up to 2 years]
OS were calculated from the time of enrollment to death or the last follow-up
Persistent MRD-negative rates and survival [through study completion, up to 2 years]
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
Treatment related adverse event(TRAE) [through study completion, up to 2 years]
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.

Other Outcome Measures

explore the molecular basis for the dynamic changes and differences in MRD [through study completion, up to 2 years]
Bone puncture samples from routine clinical consultations were collected, and single-cell transcriptome sequencing technology was applied to analyze and compare the differences in MM cells (clones) and bone marrow microenvironment (including immunity, inflammation, and stroma) of MRD-transformed and non-transformed patients after adjusting the treatment regimen, using the samples before adjusting the treatment regimen as the baseline control, in order to explore the molecular basis for the dynamic changes and differences in MRD
explore the elderly (especially debilitated) patients' MRD-adjusted treatment [through study completion, up to 2 years]
For patients ≥65 years old, through the adjusted treatment-adjusted MRD-negative rates to explore the impact of strategy adjustment on elderly patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.