Risk-adapted Therapeutic Strategy in +1q NDMM
ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFengYan Jin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Newly diagnosed NDMM by 2014 IMWG criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
risk-scoring model
Other interventionThis 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.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: low-risk +1q NDMM patients1 intervention
Group B: intermediate/high-risk +1q NDMM patients1 intervention
Group C: 1q negativity low-risk group0 interventions
Group D: 1q negativity high-risk group0 interventions
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 years4
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 yearsSecondary outcomes
1
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.
Time frame
through study completion, up to 2 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
FengYan Jin
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov
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