Real-world Immuno-therapy in Chinese Newly Diagnosed Multiple Myeloma Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: newly diagnosed multiple myeloma
Trial outcomes
Primary outcomes
1
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 20262
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 2026Secondary outcomes
1
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 20272
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.
Time frame
July 2025-July 20263
Serum Lactate Dehydrogenase Level
Serum LDH concentration measured at baseline, reported in units per liter (U/L).
Time frame
July 2025-July 20264
Age at Baseline
Patient age in years at the time of enrollment (baseline)
Time frame
July 2025-July 2026Sponsors and contacts
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Source ClinicalTrials.gov