Immunophenotyping of Plasma Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From Multiple Myeloma (MM) Patients (MYELOME-MM)

November 6, 2023 updated by: Assistance Publique Hopitaux De Marseille

The objective of this study is to evaluate the immune profile of plasma cells and immune effector cells in paired peripheral whole blood and bone marrow samples from MM patients by standardized flow cytometry. The quantitative and/or qualitative variation of these immune effectors according to the different status of myeloma pathology (diagnosis, relapse or refractory). It is interesting to assess the extent to which a particular immune profile is associated with a better therapeutic response for a given treatment.

In addition, the study will validate the stability of the samples between T0 (< 4 hours after sampling) and T0 + 72 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study the biomarkers recorded on plasma cells and normal leukocytes including T lymphocytes (naïve, effectors and memories), B lymphocytes, Treg, NK, monocytes as well as their activation markers (CD25, PD-1) in paired bone marrow and blood samples. Validate the pre-analytical stability of the samples between T0 (< 4 hours after sampling) and T0 + 72 hours.

Secondary objectives: Validate the strategy of quantification of receptors on plasma cells by direct labeling in flow cytometry. Validate a new method for measuring receptor occupancy by a drug. Validate the pre-analytical stability of the absolute quantitative expression of the receptors and the specific marker CD138 on samples between T0 (< 4 hours after sampling) and T0 + 72 hours.

The study will be enrolling 20 patients.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • APHM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Multiple myeloma without treatment

Description

Inclusion Criteria:

  • Multiple myeloma without treatment

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunophenotyped cells
Time Frame: day 0; day0+24hour; day 0+ 48hours; day0+72hours
change in % of immunophenotyped cells during time
day 0; day0+24hour; day 0+ 48hours; day0+72hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Regis Costello, AP-HM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM20_0012 - MYELOME-MM
  • 2020-A01783-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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