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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05428163

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: Biological sampling

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 20, 2022

Anticipated Primary Completion Date :

Jun 20, 2025

Anticipated Study Completion Date :

Jun 20, 2026

Outcome Measures

Primary Outcome Measures

immunophenotyped cells [day 0; day0+24hour; day 0+ 48hours; day0+72hours]
change in % of immunophenotyped cells during time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Multiple myeloma without treatment

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator: Regis Costello, AP-HM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT05428163

Other Study ID Numbers:

RCAPHM20_0012 - MYELOME-MM
2020-A01783-36

First Posted:

Jun 22, 2022

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique Hopitaux De Marseille

Immune response

Plasma cells

Multiple myeloma

Drugs targeting plasma cells

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jun 22, 2022