Peking University People's Hospital
Beijing, Beijing Municipality, China
Location status: Recruiting
NCT Number: NCT07296627
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Beijing, Beijing Municipality, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From July 2025 to July 2026
To describe the treatment patterns of Chinese NDMM patients receiving first-line immunotherapy in real-world settings.
Time frame: 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.
Time frame: 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.
Time frame: July 2025-July 2026
Disease stage classified according to the Revised International Staging System (R-ISS I, II, or III) at baseline.
Time frame: July 2025-July 2026
Serum LDH concentration measured at baseline, reported in units per liter (U/L).
Time frame: July 2025-July 2026
Patient age in years at the time of enrollment (baseline)
Time frame: July 2025-July 2026
Biological sex recorded at baseline (male or female)
Time frame: July 2025-July 2026
Type of monoclonal immunoglobulin (e.g., IgG, IgA, IgD, IgM, light chain only) determined at diagnosis.
Time frame: July 2025-July 2026
Presence of gain or amplification of chromosome region 1q21 detected by FISH at baseline
Time frame: 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
Contact information is provided by the study sponsor or research team.
Peking University People's Hospital
Other
A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting
Acronym: PRIMARY
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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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