Real-world Immuno-therapy in Chinese Newly Diagnosed Multiple Myeloma Patients

Peking University People's Hospital500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Newly Diagnosed Multiple Myeloma (NDMM)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

treatment patterns

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

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.

Time frame: From July 2025 to July 2026

Secondary Outcomes

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.

Time frame: July 2025-July 2027

Revised International Staging System (R-ISS) Stage

Disease stage classified according to the Revised International Staging System (R-ISS I, II, or III) at baseline.