Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To conduct a multicenter, prospective observational cohort study to investigate first-line immunotherapy patterns and clinical outcomes in NDMM patients in China. Leveraging the extensive patient resources of China's large center for blood disorders, the investigator will recruit approximately 500 NDMM patients to establish an NDMM patient cohort. The investigator will collect data on disease characteristics, treatment patterns, and clinical outcomes through one year of clinical follow-up. Further long-term follow-up is needed to obtain survival status and causes of death, so as to provide essential evidence for optimizing and improving patients' prognosis in clinical individualized treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| newly diagnosed multiple myeloma |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| treatment patterns | To describe the treatment patterns of Chinese NDMM patients receiving first-line immunotherapy in real-world settings. | From July 2025 to July 2026 |
| real-world overall response rate (rwORR) | To determine the clinical outcomes of Chinese NDMM patients receiving first-line immunotherapy in real-world settings.The real-world overall response rate (rwORR) of the entire population, as well as the rwORR of each treatment regimen. | From July 2025 to July 2026 |
| Measure | Description | Time Frame |
|---|---|---|
| MRD | To assess the depth of response in Chinese patients with NDMM receiving first-line immunotherapy in real-world settings, with the corresponding endpoint being minimal residual disease. | July 2025-July 2027 |
| Revised International Staging System (R-ISS) Stage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients who did not receive any follow-up after initial diagnosis
Not provided
Not provided
Not provided
it is expected that approximately 500 newly diagnosed multiple myeloma patients will be able to participate in the study during the study period of the selected centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. LIU, MD | Contact | +8613716926210 | pkuphliuyang@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Prof. LU, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Disease stage classified according to the Revised International Staging System (R-ISS I, II, or III) at baseline. |
| July 2025-July 2026 |
| Serum Lactate Dehydrogenase Level | Serum LDH concentration measured at baseline, reported in units per liter (U/L). | July 2025-July 2026 |
| Age at Baseline | Patient age in years at the time of enrollment (baseline) | July 2025-July 2026 |
| Sex | Biological sex recorded at baseline (male or female) | July 2025-July 2026 |
| M-Protein Isotype | Type of monoclonal immunoglobulin (e.g., IgG, IgA, IgD, IgM, light chain only) determined at diagnosis. | July 2025-July 2026 |
| Gain of Chromosome 1q21 by FISH | Presence of gain or amplification of chromosome region 1q21 detected by FISH at baseline | July 2025-July 2026 |
| Ultra-High-Risk Cytogenetic Abnormalities (UHRCA) | Presence of ultra-high-risk genetic features defined as: TP53 biallelic inactivation, ≥2 high-risk cytogenetic lesions (e.g., del(17p), t(4;14), amp(1q)), circulating plasma cells ≥2%, or primary refractory disease | July 2025-July 2026 |