NCT07180992

Brief Summary

Tumoral micro-environment in malignant haematological diseases, notably in multiple myeloma, is active on plasma cells survival and proliferation. Monocytosis and monocytes typing are described in multiple myeloma response as factors on proliferation and cell death evasion. CART cells have improved multiple myeloma care in last 5 years, nethertheless, early relapse occur and we must identify predictor factors of better response. The aim of this study is to analyze basic level and phenotyping of monocytes before and after CART cells infusion and study their impact on multiple myeloma response

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
28mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress26%
Jul 2025Sep 2028

Study Start

First participant enrolled

July 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

September 2, 2025

Last Update Submit

November 17, 2025

Conditions

Multiple MyelomaMonocytesCART Cells

Keywords

Multiple myelomaMonocytesCART cellsMicroenvironment

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    day 1

Secondary Outcomes (3)

  • Progression free survival

    3 years

  • Overall survival

    3 years

  • time to next treatment

    3 years

Eligibility Criteria

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

Patients over 18 years old Treated for a multiple myeloma

You may qualify if:

  • Patients over 18 years old
  • Treated for a multiple myeloma
  • CART cells treatment proposed
  • Affiliated to social security system
  • Agreed to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Amiens, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine blood withdrawal

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lydia Montes, MD

CONTACT

33+322088371Montes.lydia@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 18, 2025

Study Start

July 16, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)