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NCT Number: NCT07045168

Risk-adapted Therapeutic Strategy in +1q NDMM

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

risk-scoring model

Other

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.

Other names: Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma

Primary outcomes

  1. MRD negativity rate

    Time frame: 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.

  2. sustained MRD negativity rate

    Time frame: 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.

  3. Progression-Free Survival (PFS)

    Time frame: through study completion, up to 2 years

    PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death

  4. Overall Survival (OS)

    Time frame: through study completion, up to 2 years

    OS were calculated from the time of enrollment to death or the last follow-up

  5. objective response rate

    Time frame: 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).

  6. Treatment related adverse event(TRAE)

    Time frame: 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.

Secondary outcomes

  1. differences between MRD-negative and MRD-positive patients

    Time frame: 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.

  2. elderly +1q NDMM patients

    Time frame: 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.

  3. The efficacy of 1q negativity patients

    Time frame: 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) .

  4. The survival of 1q negativity patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

FengYan Jin

Other

Registry information

Official study title

Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jul 1, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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