Risk-adapted Therapeutic Strategy in +1q NDMM

FengYan Jin

Status: Not yet enrolling

Conditions: Multiple Myeloma

Treatments: Other: risk-scoring model

Study type: Observational

Funder types: Other

Identifiers

NCT07045168

Risk-adapted therapy

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 4 patient groups

low-risk +1q NDMM patients

Description:

This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting International Staging System (ISS) stage III, hypercalcemia, high lactate dehydrogenase (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) .

Treatment:

Other: risk-scoring model

intermediate/high-risk +1q NDMM patients

Description:

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 was classified into intermediate- (1-3 points) and high-risk (4-7 points) groups.

Treatment:

Other: risk-scoring model

1q negativity low-risk group

Description:

Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.

1q negativity high-risk group

Description:

Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.