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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05428163
Acronym
MYELOME-MM
Enrollment
20
Registered
2022-06-22
Start date
2022-10-04
Completion date
2023-05-23
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Immune response, Plasma cells, Multiple myeloma, Drugs targeting plasma cells

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.

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

OTHERBiological sampling

3ml of blood

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Multiple myeloma without treatment

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
immunophenotyped cellsday 0; day0+24hour; day 0+ 48hours; day0+72hourschange in % of immunophenotyped cells during time

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026