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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Newly Diagnosed Multiple Myeloma (NDMM)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Prof. LIU, MD; Phone Number: +8613716926210; Email: pkuphliuyang@bjmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
newly diagnosed multiple myeloma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	July 2025-July 2027
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.	July 2025-July 2026
Serum Lactate Dehydrogenase Level	Serum LDH concentration measured at baseline, reported in units per liter (U/L).	July 2025-July 2026
Age at Baseline	Patient age in years at the time of enrollment (baseline)	July 2025-July 2026
Sex	Biological sex recorded at baseline (male or female)	July 2025-July 2026
M-Protein Isotype	Type of monoclonal immunoglobulin (e.g., IgG, IgA, IgD, IgM, light chain only) determined at diagnosis.	July 2025-July 2026
Gain of Chromosome 1q21 by FISH	Presence of gain or amplification of chromosome region 1q21 detected by FISH at baseline	July 2025-July 2026
Ultra-High-Risk Cytogenetic Abnormalities (UHRCA)	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	July 2025-July 2026

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Prof. LU, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Immuno-therapy; anti-CD38 monoclonal antibodies
• Other Study ID Numbers: 2024PHB463-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No