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

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ClinicalTrials.gov Identifier: NCT04242121
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ivan S Moiseev, St. Petersburg State Pavlov Medical University

Tracking Information
First Submitted Date January 23, 2020
First Posted Date January 27, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date January 15, 2020
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2020)
Time-to-progression according to circulating plasma cells [ Time Frame: [Time Frame: 3 years] ]
Measured by cumulative incidence estimates
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 23, 2020)
  • Progression-free survival [ Time Frame: [Time Frame: 3 years] ]
    Measured by Kaplan-Meier estimates
  • Overall survival [ Time Frame: [Time Frame: 3 years] ]
    Measured by Kaplan-Meier estimates
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with newly diagnosed multiple myeloma (both with and withous auto-SCT groups) at the different stages of treatment
Condition Myeloma Multiple
Intervention Diagnostic Test: fluorescence flow cytometry
Countification of plasma cells by fluorescence flow cytometry (hematology analyzer XN-1000/20)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2024
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pirogova Olga, MD, PhD +78123386259 dr.pirogova@gmail.com
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04242121
Other Study ID Numbers 222/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ivan S Moiseev, St. Petersburg State Pavlov Medical University
Study Sponsor Ivan S Moiseev
Collaborators Not Provided
Investigators Not Provided
PRS Account St. Petersburg State Pavlov Medical University
Verification Date January 2020