This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.
Study Type
OBSERVATIONAL
Enrollment
200
This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point),intermediate- (1-3 points), and high-risk (4-7 points) groups.
The First Hospital of Jilin University
Changchun, Jilin, China
MRD negativity rate
To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Time frame: through study completion, up to 2 years
sustained MRD negativity rate
To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Time frame: through study completion, up to 2 years
Progression-Free Survival (PFS)
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Time frame: 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
Time frame: through study completion, up to 2 years
objective response rate
To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).
Time frame: 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.
Time frame: through study completion, up to 2 years
differences between MRD-negative and MRD-positive patients
Number of participants with distinct immunological (T-cell subsets by flow cytometry), inflammatory (CRP, IL-6 levels), genomic (mutational burden by NGS), and proteomic (LC-MS/MS) signatures in MRD-negative vs. MRD-positive patients.
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Time frame: through study completion, up to 2 years
elderly +1q NDMM patients
Number of participants achieving MRD negativity (by next-generation sequencing \[NGS\] at 10\^-5 sensitivity) and progression-free survival (PFS) at 24 months in elderly intermediate/high-risk +1q NDMM patients receiving MRD-tailored therapy.
Time frame: through study completion, up to 2 years
The efficacy of 1q negativity patients
Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The efficacy of these patients were compared with those of patients stratified by 1q risk through objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR) .
Time frame: through study completion, up to 2 years
The survival of 1q negativity patients
Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The survival of these patients were compared with those of patients stratified by 1q risk through PFS and OS
Time frame: through study completion, up to 2 years