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NCT Number: NCT07296627

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. treatment patterns

    Time frame: From July 2025 to July 2026

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

  2. real-world overall response rate (rwORR)

    Time frame: From July 2025 to July 2026

    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.

Secondary outcomes

  1. MRD

    Time frame: July 2025-July 2027

    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.

  2. Revised International Staging System (R-ISS) Stage

    Time frame: July 2025-July 2026

    Disease stage classified according to the Revised International Staging System (R-ISS I, II, or III) at baseline.

  3. Serum Lactate Dehydrogenase Level

    Time frame: July 2025-July 2026

    Serum LDH concentration measured at baseline, reported in units per liter (U/L).

  4. Age at Baseline

    Time frame: July 2025-July 2026

    Patient age in years at the time of enrollment (baseline)

  5. Sex

    Time frame: July 2025-July 2026

    Biological sex recorded at baseline (male or female)

  6. M-Protein Isotype

    Time frame: July 2025-July 2026

    Type of monoclonal immunoglobulin (e.g., IgG, IgA, IgD, IgM, light chain only) determined at diagnosis.

  7. Gain of Chromosome 1q21 by FISH

    Time frame: July 2025-July 2026

    Presence of gain or amplification of chromosome region 1q21 detected by FISH at baseline

  8. Ultra-High-Risk Cytogenetic Abnormalities (UHRCA)

    Time frame: July 2025-July 2026

    Presence of ultra-high-risk genetic features defined as: TP53 biallelic inactivation, ≥2 high-risk cytogenetic lesions (e.g., del(17p), t(4;14), amp(1q)), circulating plasma cells ≥2%, or primary refractory disease

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. LIU, MD

CONTACT

[email protected]

+8613716926210

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting

Acronym: PRIMARY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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