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

Sponsor
Ivan S Moiseev (Other)
Overall Status
Recruiting
CT.gov ID
NCT04242121
Collaborator
(none)
100
1
48.5
2.1

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
  • Diagnostic Test: fluorescence flow cytometry

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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 15, 2020
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Time-to-progression according to circulating plasma cells [[Time Frame: 3 years]]

    Measured by cumulative incidence estimates

Secondary Outcome Measures

  1. Progression-free survival [[Time Frame: 3 years]]

    Measured by Kaplan-Meier estimates

  2. Overall survival [[Time Frame: 3 years]]

    Measured by Kaplan-Meier estimates

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Ivan S Moiseev, Vice-director for science R.M. Gorbacheva Memorial Institute for Pediatric Oncology, Hematology and Transplantation, St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier:
NCT04242121
Other Study ID Numbers:
  • 222/2019
First Posted:
Jan 27, 2020
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022