NCT05428163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

June 14, 2022

Last Update Submit

November 6, 2023

Conditions

Multiple Myeloma

Keywords

Immune responsePlasma cellsMultiple myelomaDrugs targeting plasma cells

Outcome Measures

Primary Outcomes (1)

  • immunophenotyped cells

    change in % of immunophenotyped cells during time

    day 0; day0+24hour; day 0+ 48hours; day0+72hours

Interventions

Biological samplingOTHER

3ml of blood

Also known as: blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with Multiple myeloma without treatment

You may qualify if:

  • Multiple myeloma without treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHM

Marseille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Regis Costello

    AP-HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 22, 2022

Study Start

October 4, 2022

Primary Completion

May 23, 2023

Study Completion

May 23, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)