Newly Diagnosed Multiple Myeloma (NDMM)PRIMARYNCT07296627
Real-world Immuno-therapy in Chinese Newly Diagnosed Multiple Myeloma Patients
An observational study of Newly Diagnosed Multiple Myeloma (NDMM), run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma (NDMM)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to 15 Nov 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who did not receive any follow-up after initial diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
About this study
Official title: 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.
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- Keywords
- Immuno-therapy, anti-CD38 monoclonal antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed multiple myeloma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment patterns
To describe the treatment patterns of Chinese NDMM patients receiving first-line immunotherapy in real-world settings.
Measured: 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.
Measured: From July 2025 to July 2026
Secondary outcomes (8)
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.
Measured: 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.
Measured: July 2025-July 2026
Serum Lactate Dehydrogenase Level
Serum LDH concentration measured at baseline, reported in units per liter (U/L).
Measured: July 2025-July 2026
Age at Baseline
Patient age in years at the time of enrollment (baseline)
Measured: July 2025-July 2026
Sex
Biological sex recorded at baseline (male or female)
Measured: July 2025-July 2026
M-Protein Isotype
Type of monoclonal immunoglobulin (e.g., IgG, IgA, IgD, IgM, light chain only) determined at diagnosis.
Measured: July 2025-July 2026
Gain of Chromosome 1q21 by FISH
Presence of gain or amplification of chromosome region 1q21 detected by FISH at baseline
Measured: 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
Measured: July 2025-July 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start16 Jul 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple Myeloma (NDMM)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Prof. LU, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296627
- Sponsor's protocol ID
- 2024PHB463-001
- Acronym
- PRIMARY
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting
- ClinicalTrials.gov ID
- NCT07296627
- Acronym / sponsor ID
- PRIMARY / 2024PHB463-001
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- Keywords
- Immuno-therapy, anti-CD38 monoclonal antibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed multiple myeloma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who did not receive any follow-up after initial diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
MRD
Time frame: July 2025-July 2027
Revised International Staging System (R-ISS) Stage
Time frame: July 2025-July 2026
Serum Lactate Dehydrogenase Level
Time frame: July 2025-July 2026
Age at Baseline
Time frame: July 2025-July 2026
Sex
Time frame: July 2025-July 2026
M-Protein Isotype
Time frame: July 2025-July 2026
Gain of Chromosome 1q21 by FISH
Time frame: July 2025-July 2026
Ultra-High-Risk Cytogenetic Abnormalities (UHRCA)
Time frame: July 2025-July 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. LU, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Multiple Myeloma (NDMM), run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. LIU, MD (+8613716926210, pkuphliuyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment patterns (time frame: From July 2025 to July 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.