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

NCT07296627 | Recruiting

• 1 other identifier: 2024PHB463-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newly Diagnosed Multiple Myeloma (NDMM)

Keywords

Immuno-therapy; anti-CD38 monoclonal antibodies

Outcome Measures

Primary Outcomes (2)

• treatment patterns

  To describe the treatment patterns of Chinese NDMM patients receiving first-line immunotherapy in real-world settings.

  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.

  From July 2025 to July 2026

Secondary Outcomes (8)

• MRD

  July 2025-July 2027

• Revised International Staging System (R-ISS) Stage

  July 2025-July 2026

• Serum Lactate Dehydrogenase Level

  July 2025-July 2026

• Age at Baseline

  July 2025-July 2026

• Sex

  July 2025-July 2026

Study Arms (1)

newly diagnosed multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• \- Patients who did not receive any follow-up after initial diagnosis

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Prof. LU, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. LIU, MD

CONTACT

+8613716926210; pkuphliuyang@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)