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

NCT04242121 | Terminated

• 1 other identifier: 222/2019
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (1)

• Time-to-progression according to circulating plasma cells

  Measured by cumulative incidence estimates

  [Time Frame: 3 years]

Secondary Outcomes (2)

• Progression-free survival

  [Time Frame: 3 years]

• Overall survival

  [Time Frame: 3 years]

Interventions

fluorescence flow cytometry DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Monoclonal gammopathies of undefined significance
• Smoldering Multiple Myeloma
• Plasma cell leukemia

Sponsors & Collaborators

• Ivan S Moiseev: lead

Study Sites (1)

Boris V Afanasyev, MD, Prof.

Saint Petersburg, 197089, Russia

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-director for science R.M. Gorbacheva Memorial Institute for Pediatric Oncology, Hematology and Transplantation

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: January 15, 2020
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)