Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Risk-adapted therapeutic strategy, +1q MM, high-risk MM, minimal residual disease
Brief summary
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.
Interventions
OTHERrisk-scoring model
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.
Sponsors
FengYan Jin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age \>=18, or \>=65 and fit according to IMWG-FI. * Newly diagnosed NDMM by 2014 IMWG criteria. * Adequate organ function for systemic therapy. * Signed informed consent.
Exclusion criteria
* Active infections requiring systemic treatment. * Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias. * History of hematologic or solid tumors treated with chemo/radiotherapy within 5 years. * Current malignancies requiring therapy. * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| sustained MRD negativity rate | through study completion, up to 2 years | To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment. |
| 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 |
| objective response rate | through study completion, up to 2 years | To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR). |
| MRD negativity rate | through study completion, up to 2 years | To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| elderly +1q NDMM patients | through study completion, up to 2 years | 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. |
| The efficacy of 1q negativity patients | through study completion, up to 2 years | 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) . |
| The survival of 1q negativity patients | through study completion, up to 2 years | 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 |
| differences between MRD-negative and MRD-positive patients | through study completion, up to 2 years | 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. |
Countries
China
Outcome results
None listed