Real-world Immuno-therapy in Chinese Newly Diagnosed Multiple Myeloma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Newly Diagnosed Multiple Myeloma (NDMM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting
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.
Primary outcome measures
- treatment patterns [Time frame: From July 2025 to July 2026]
- real-world overall response rate (rwORR) [Time frame: From July 2025 to July 2026]
Secondary outcome measures (8)
- MRD [Time frame: July 2025-July 2027]
- Revised International Staging System (R-ISS) Stage [Time frame: July 2025-July 2026]
- Serum Lactate Dehydrogenase Level [Time frame: July 2025-July 2026]
- Age at Baseline [Time frame: July 2025-July 2026]
- Sex [Time frame: July 2025-July 2026]
- M-Protein Isotype [Time frame: July 2025-July 2026]
- Gain of Chromosome 1q21 by FISH [Time frame: July 2025-July 2026]
- Ultra-High-Risk Cytogenetic Abnormalities (UHRCA) [Time frame: July 2025-July 2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07296627 · 2024PHB463-001