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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Myeloma Multiple 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.

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Study Type : Observational
Estimated 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 : January 15, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


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


Primary Outcome Measures :
  1. Time-to-progression according to circulating plasma cells [ Time Frame: [Time Frame: 3 years] ]
    Measured by cumulative incidence estimates


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: [Time Frame: 3 years] ]
    Measured by Kaplan-Meier estimates

  2. Overall survival [ Time Frame: [Time Frame: 3 years] ]
    Measured by Kaplan-Meier estimates



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242121


Contacts
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Contact: Pirogova Olga, MD, PhD +78123386259 dr.pirogova@gmail.com

Locations
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Russian Federation
Boris V Afanasyev, MD, Prof. Recruiting
Saint Petersburg, Russian Federation, 197089
Contact: Olga V Pirogova, PhD    +79214419016    dr.pirogova@gmail.com   
Contact: Ivan S Moiseev, PhD    +79217961951    moisiv@mail.ru   
Sub-Investigator: Mikhail M Kannunnikov, MD         
Sponsors and Collaborators
Ivan S Moiseev
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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: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases