risk-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.
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
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.
Primary outcome measure(s)
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.
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).
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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