Multiple MyelomaNCT05536700
Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma
An observational study of Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects diagnosed with MM.
Who may be able to join
- Subjects with available baseline and sequential serum samples.
Who cannot join
- Subjects without baseline and sequential serum samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
InsituteHBDH
Tianjin, 300000
Gang An, PhD&MD, 008613502181109, angang@ihcams.ac.cn
About this study
Official title: Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma
The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.
- Conditions
- Multiple Myeloma
- Keywords
- mass spectrometry, serum immunoglobulin, minimal residual disease, MRD, EasyM, M protein
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measurement of M protein
Detecting the M protein concentration and its dynamic change curve
Measured: From June 6, 2022 to December 31, 2022
Secondary outcomes (1)
sequence detection of M protein
Detecting the M protein sequence in each person
Measured: From December 31, 2021 to May 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start31 Dec 2021
- Primary completion17 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Kuaixu Biotechnology Co., Ltd
- Responsible party
- Principal investigator, AnGang,MD, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- InstituteHBDH, Principal investigator, Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536700
- Sponsor's protocol ID
- EasyM-MM-2021
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767.
PubMed 38170583
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05536700
- Acronym / sponsor ID
- EasyM-MM-2021
- Conditions
- Multiple Myeloma
- Keywords
- mass spectrometry, serum immunoglobulin, minimal residual disease, MRD, EasyM, M protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Kuaixu Biotechnology Co., Ltd
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 17 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Sep 2022 (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 presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with MM.
Key inclusion criteria (1 listed)
- Subjects with available baseline and sequential serum samples.
Key exclusion criteria (1 listed)
- Subjects without baseline and sequential serum samples.
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
Quantitative measurement of M protein
Time frame: From June 6, 2022 to December 31, 2022
Detecting the M protein concentration and its dynamic change curve
1 secondary outcome
sequence detection of M protein
Time frame: From December 31, 2021 to May 31, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 38170583Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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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. This study is not recruiting at the moment.
InstituteHBDH principal investigator
Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020
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, run by Institute of Hematology & Blood Diseases Hospital, China 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 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang An (00861350218110, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measurement of M protein (time frame: From June 6, 2022 to December 31, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536700, which also lists 1 linked publication.
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 13 Sep 2022.