The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
Study Details
Study Description
Brief 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. 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.
Condition or Disease | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- Time-to-progression according to circulating plasma cells [[Time Frame: 3 years]]
Measured by cumulative incidence estimates
Secondary Outcome Measures
- Progression-free survival [[Time Frame: 3 years]]
Measured by Kaplan-Meier estimates
- Overall survival [[Time Frame: 3 years]]
Measured by Kaplan-Meier estimates
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis: Newly diagnosed symptomatic multiple myeloma
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Signed informed consent
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No second tumors
Exclusion Criteria:
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Monoclonal gammopathies of undefined significance
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Smoldering Multiple Myeloma
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Plasma cell leukemia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Boris V Afanasyev, MD, Prof. | Saint Petersburg | Russian Federation | 197089 |
Sponsors and Collaborators
- Ivan S Moiseev
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 222/2019