First-line immunotherapy in Chinese adults with newly diagnosed multiple myeloma
A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting
Peking University People's Hospital · NCT07296627
This study will test how first-line immunotherapy treatments—including anti-CD38 antibodies, proteasome inhibitors, and IMiDs—work in adults newly diagnosed with multiple myeloma in China over one year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07296627 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort enrolling approximately 500 adults with newly diagnosed multiple myeloma who plan to receive first-line immunotherapy at participating Chinese centers. Investigators will record baseline disease features, specific treatment regimens (anti-CD38 monoclonal antibodies, proteasome inhibitors, IMiDs, and combinations), and clinical outcomes during one year of follow-up. Data collection will focus on real-world treatment patterns, response rates, and short-term safety, with plans for longer-term follow-up to capture survival and causes of death. The goal is to generate real-world evidence to inform individualized treatment choices in Chinese NDMM patients.
Who should consider this trial
Good fit: Adults (age ≥18) with newly diagnosed multiple myeloma who plan to start first-line immunotherapy at a participating center and can provide informed consent and attend follow-up visits.
Not a fit: Patients who do not receive any follow-up after diagnosis or who do not undergo first-line immunotherapy at participating centers are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, this work could help identify which first-line immunotherapy patterns are associated with better outcomes and guide more personalized treatment choices for newly diagnosed patients.
How similar studies have performed: Clinical trials and real-world studies of anti-CD38 antibodies and combination regimens have already improved response rates in NDMM, so this study builds on established therapies by documenting their real-world use in China.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Prof. LU, MD — Peking University People's Hospital
- Study coordinator: Prof. LIU, MD
- Email: pkuphliuyang@bjmu.edu.cn
- Phone: +8613716926210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Newly Diagnosed Multiple Myeloma, Immuno-therapy, anti-CD38 monoclonal antibodies