Myeloma MultipleNCT04242121
The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
An observational study of Myeloma Multiple, run by Ivan S Moiseev at 1 site in Russia.
Trial summary
The main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- fluorescence flow cytometry
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2020to 6 May 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed multiple myeloma (both with and withous auto-SCT groups) at the different stages of treatment
Who may be able to join
- Diagnosis: Newly diagnosed symptomatic multiple myeloma
- Signed informed consent
- No second tumors
Who cannot join
- Monoclonal gammopathies of undefined significance
- Smoldering Multiple Myeloma
- Plasma cell leukemia
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. This clinical study is observational and does not involve drugs. 100 subjects with newly diagnosed multiple myeloma will be enrolled in this study and followed for 3 years.
Read the detailed description
The presence of circulating plasma cells in patients with multiple myeloma is considered as a marker for highly proliferative disease and associated with a worse prognosis.
Plasma cell counting is conventionally done by means of peripheral blood film morphology using light microscopy. However, this manual method is laborious as well as imprecise due to the low number of cells counted, and inter-observer variability. Flow cytometry with monoclonal antibodies is unsuitable as a screening test. The procedure is not automated, and it is expensive and time consuming. Therefore, new rapid, effective and inexepensive methods are needed for risk-stratification in patients with multiple myeloma.
Automated antibody-synthesizing or secreting cells counting from routine haematology systems (XN-1000/20) without sample preparation and in less than 1 minute will further reduce the workload in haematology laboratories and it can be used for counting circulating plasma cells in peripheral blood in patients with multiple myeloma.
- Conditions
- Myeloma Multiple
- Being tested
- fluorescence flow cytometry
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence flow cytometryDiagnostic test
Countification of plasma cells by fluorescence flow cytometry (hematology analyzer XN-1000/20)
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-progression according to circulating plasma cells
Measured by cumulative incidence estimates
Measured: [Time Frame: 3 years]
Secondary outcomes (2)
Progression-free survival
Measured by Kaplan-Meier estimates
Measured: [Time Frame: 3 years]
Overall survival
Measured by Kaplan-Meier estimates
Measured: [Time Frame: 3 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Jan 2020
- Primary completion6 May 2024
- Study completion6 May 2024
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivan S Moiseev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242121
- Sponsor's protocol ID
- 222/2019
- Status last verified
- May 2024
- First submitted
- 23 Jan 2020
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
- ClinicalTrials.gov ID
- NCT04242121
- Acronym / sponsor ID
- 222/2019
- Conditions
- Myeloma Multiple
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ivan S MoiseevUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 27 Jan 2020 (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 main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. This clinical study is observational and does not involve drugs. 100 subjects with newly diagnosed multiple myeloma will be enrolled in this study and followed for 3 years.
Detailed description
The presence of circulating plasma cells in patients with multiple myeloma is considered as a marker for highly proliferative disease and associated with a worse prognosis.
Plasma cell counting is conventionally done by means of peripheral blood film morphology using light microscopy. However, this manual method is laborious as well as imprecise due to the low number of cells counted, and inter-observer variability. Flow cytometry with monoclonal antibodies is unsuitable as a screening test. The procedure is not automated, and it is expensive and time consuming. Therefore, new rapid, effective and inexepensive methods are needed for risk-stratification in patients with multiple myeloma.
Automated antibody-synthesizing or secreting cells counting from routine haematology systems (XN-1000/20) without sample preparation and in less than 1 minute will further reduce the workload in haematology laboratories and it can be used for counting circulating plasma cells in peripheral blood in patients with multiple myeloma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed multiple myeloma (both with and withous auto-SCT groups) at the different stages of treatment
Key inclusion criteria (3 listed)
- Diagnosis: Newly diagnosed symptomatic multiple myeloma
- Signed informed consent
- No second tumors
Key exclusion criteria (3 listed)
- Monoclonal gammopathies of undefined significance
- Smoldering Multiple Myeloma
- Plasma cell leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescence flow cytometryCountification of plasma cells by fluorescence flow cytometry (hematology analyzer XN-1000/20) | Diagnostic test | – |
Primary outcome
Time-to-progression according to circulating plasma cells
Time frame: [Time Frame: 3 years]
Measured by cumulative incidence estimates
2 secondary outcomes
Progression-free survival
Time frame: [Time Frame: 3 years]
Overall survival
Time frame: [Time Frame: 3 years]
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Myeloma Multiple, run by Ivan S Moiseev at 1 site in Russia.
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: stopped early, as of the sponsor's last update on 8 May 2024. 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 Russia. 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?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-progression according to circulating plasma cells (time frame: [Time Frame: 3 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 8 May 2024.