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

NCT ID: NCT07296627

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-16

Study Completion Date

2027-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Newly Diagnosed Multiple Myeloma (NDMM)

Keywords

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Immuno-therapy anti-CD38 monoclonal antibodies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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newly diagnosed multiple myeloma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin Lu, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof. LU, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Prof. LIU, MD

Role: CONTACT

Phone: +8613716926210

Email: [email protected]

Other Identifiers

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2024PHB463-001

Identifier Type: -

Identifier Source: org_study_id