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

Myeloma Multiple Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04242121
• Other study ID #: 222/2019
• Status: Recruiting
• Start date: January 15, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2022
• Source: St. Petersburg State Pavlov Medical University
• Contact: Pirogova Olga, MD, PhD
• Phone: +78123386259
• Email: dr.pirogova[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Boris V Afanasyev, MD, Prof.	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Ivan S Moiseev

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-progression according to circulating plasma cells	Measured by cumulative incidence estimates	[Time Frame: 3 years]
Secondary	Progression-free survival	Measured by Kaplan-Meier estimates	[Time Frame: 3 years]
Secondary	Overall survival	Measured by Kaplan-Meier estimates	[Time Frame: 3 years]