Multiple Myeloma and Other Plasma Cell NeoplasmsNCT06760052
Longitudinal Data Registry of Plasma Cell Dyscrasia
An observational study of Multiple Myeloma and Other Plasma Cell Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and… Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Multiple Myeloma and Other Plasma Cell Neoplasms
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2028
- 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 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathological diagnosis of PCD from 2007 to 2027 according to 2016 WHO classification.
Who may be able to join
- Patients with pathological diagnosis of PCD [e.g., symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis] from 2007 to 2027 in Zhongshan Hospital or other collaborating centers.
- Patients who had complete diagnostic, treatment, and follow-up records.
- Patients with full comprehension and signature of the informed consent form (ICF) for participation.
Who cannot join
- Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period.
- Patients who suffered from severe mental illness.
- Patients who were deemed unsuitable for inclusion by the investigator.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Peng Liu, Ph.D, +862164041990 ext 2315, liu.peng@zs-hospital.sh.cn
About this study
Official title: Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up
The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are:
Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes?
Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.
Read the detailed description
PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtypes of this disease spectrum. This study is a non-interventional, real-world, multicenter study. All registered data are collected from real-world clinical practice. The medical data include patient demographics, tumor characteristics, laboratory examinations, treatment history, adverse reactions, efficacy results, and potential prognostic factors.
- Medical subject headings
- Neoplasms, Plasma Cell
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 |
|---|---|---|
| Enrolled patients | The final personalized management strategy is determined based on both current conventional treatment options and physicians' and patients' preferences. The following agents might be applied: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), alkylating agents, anti-CD38 monoclonal antibodies, bispecific antibodies, and cell therapy, with or without steroids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause.
Measured: From the time of enrollment to data cut-off (Up to approximately 20 years).
Secondary outcomes (1)
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death of any cause, whichever occurs first.
Measured: From the time of enrollment to data cut-off (Up to approximately 20 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Other Plasma Cell NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Peking University First Hospital, The First Affiliated Hospital with Nanjing Medical University, Zhongshan Hospital Xiamen University, First Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Huzhou Central Hospital, Affiliated Central Hospital HuZhou University, Huadong Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Third Affiliated Hospital of Nanjing Medical University, Peking University Shenzhen Hospital, Zhejiang Provincial Tongde Hospital, Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University, Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus), The First Affiliated Hospital, Fujian Medical University, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Peng Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760052
- Sponsor's protocol ID
- SHZS-PCD-001
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up
- ClinicalTrials.gov ID
- NCT06760052
- Acronym / sponsor ID
- SHZS-PCD-001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital, Peking University First Hospital, The First Affiliated Hospital with Nanjing Medical University, Zhongshan Hospital Xiamen University, First Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Huzhou Central Hospital, Affiliated Central Hospital HuZhou University, Huadong Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Third Affiliated Hospital of Nanjing Medical University, Peking University Shenzhen Hospital, Zhejiang Provincial Tongde Hospital, Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University, Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus), The First Affiliated Hospital, Fujian Medical University, Guangdong Provincial People's Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jan 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.
The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are:
Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes?
Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.
Detailed description
PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtypes of this disease spectrum. This study is a non-interventional, real-world, multicenter study. All registered data are collected from real-world clinical practice. The medical data include patient demographics, tumor characteristics, laboratory examinations, treatment history, adverse reactions, efficacy results, and potential prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients | – | –The final personalized management strategy is determined based on both current conventional treatment options and physicians' and patients' preferences. The following agents might be applied: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), alkylating agents, anti-CD38 monoclonal antibodies, bispecific antibodies, and cell therapy, with or without steroids. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathological diagnosis of PCD from 2007 to 2027 according to 2016 WHO classification.
Key inclusion criteria (3 listed)
- Patients with pathological diagnosis of PCD [e.g., symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis] from 2007 to 2027 in Zhongshan Hospital or other collaborating centers.
- Patients who had complete diagnostic, treatment, and follow-up records.
- Patients with full comprehension and signature of the informed consent form (ICF) for participation.
Key exclusion criteria (3 listed)
- Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period.
- Patients who suffered from severe mental illness.
- Patients who were deemed unsuitable for inclusion by the investigator.
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
Overall survival
Time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).
Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause.
1 secondary outcome
Progression-free survival
Time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).
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 3 Aug 2026.
- 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.
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 Multiple Myeloma and Other Plasma Cell Neoplasms, run by Shanghai Zhongshan 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 3 inclusion and 3 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 3 Aug 2026. 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 Peng Liu, Ph.D (+862164041990 ext 2315, liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).). 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 3 Aug 2026.