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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 20, 2025

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.

Interventions

  • Other: Biological sampling
    • 3ml of blood

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Multiple myeloma without treatment Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique Hopitaux De Marseille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Regis Costello, Principal Investigator, AP-HM
  • Overall Contact(s)
    • Anaïs Maugard, 0494145529, anais.maugard@ap-hm.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.