Risk-adapted Therapeutic Strategy in +1q NDMM

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Trial sites (1)

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