Newly Diagnosed Multiple Myeloma (NDMM)
Conditions
Keywords
Immuno-therapy, anti-CD38 monoclonal antibodies
Brief summary
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.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed multiple myeloma (NDMM) * Plan to receive first-line immunotherapy at the respective research center * First-line immunotherapy includes proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), or anti-CD38 monoclonal antibodies, used alone or in combination with each other or with other treatments * Age ≥ 18 years * Ability to understand the purpose of the study and follow-up process * Willingness to provide signed and dated written informed consent
Exclusion criteria
\- Patients who did not receive any follow-up after initial diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment patterns | From July 2025 to July 2026 | To describe the treatment patterns of Chinese NDMM patients receiving first-line immunotherapy in real-world settings. |
| real-world overall response rate (rwORR) | From July 2025 to July 2026 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultra-High-Risk Cytogenetic Abnormalities (UHRCA) | July 2025-July 2026 | 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 |
| MRD | July 2025-July 2027 | 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. |
| Revised International Staging System (R-ISS) Stage | July 2025-July 2026 | Disease stage classified according to the Revised International Staging System (R-ISS I, II, or III) at baseline. |
| M-Protein Isotype | July 2025-July 2026 | Type of monoclonal immunoglobulin (e.g., IgG, IgA, IgD, IgM, light chain only) determined at diagnosis. |
| Age at Baseline | July 2025-July 2026 | Patient age in years at the time of enrollment (baseline) |
| Sex | July 2025-July 2026 | Biological sex recorded at baseline (male or female) |
| Serum Lactate Dehydrogenase Level | July 2025-July 2026 | Serum LDH concentration measured at baseline, reported in units per liter (U/L). |
| Gain of Chromosome 1q21 by FISH | July 2025-July 2026 | Presence of gain or amplification of chromosome region 1q21 detected by FISH at baseline |
Countries
China
Contacts
Primary ContactProf. LIU, MD
Outcome results
None listed