The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood

NCT ID: NCT04242121

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-15

Study Completion Date

2024-05-06

Brief Summary

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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

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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

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Myeloma Multiple

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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fluorescence flow cytometry

Countification of plasma cells by fluorescence flow cytometry (hematology analyzer XN-1000/20)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosis: Newly diagnosed symptomatic multiple myeloma
* Signed informed consent
* No second tumors

Exclusion Criteria

* Monoclonal gammopathies of undefined significance
* Smoldering Multiple Myeloma
* Plasma cell leukemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ivan S Moiseev

OTHER

Sponsor Role lead

Responsible Party

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Ivan S Moiseev

Vice-director for science R.M. Gorbacheva Memorial Institute for Pediatric Oncology, Hematology and Transplantation

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Boris V Afanasyev, MD, Prof.

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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222/2019

Identifier Type: -

Identifier Source: org_study_id

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