Impact of lenalidomide on immune cell expression in multiple myeloma

Phase 1

Conditions: Multiple Myeloma
MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-000987-31-FR

Lead Sponsor: CHU Rennes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

- Patient with newly diagnosed multiple myeloma;
- Patient not eligible for intensive treatment;
- Patient for whom first-line treatment with Lenalidomide-Dexamethasone will be initiated;
- Patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle.
- Patient aged 18 years or older;
- Patient who has given free, informed and written consent;
- Patient affiliated to a social security scheme
- For women of childbearing age, use of effective contraception

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Patient with relapsed multiple myeloma;
- Patient eligible for intensive treatment;
- Patient for whom chemotherapy involves treatment other than Lenalidomide-Dexamethasone;
- Patient with a contraindication to lenalidomide treatment
- Pregnant or breastfeeding woman;
- Person subject to legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the activation of medullary lymphocytes after a lenalidomide-dexamethasone cycle in patients with newly diagnosed multiple myeloma. ;Secondary Objective: Characterize the phenotypic modulations of the immune subpopulations induced by Lenalidomide in the marrow of multiple myeloma patients.<br>Characterize the phenotypic modulations of lenalidomide induced tumor plasma cells in the marrow of multiple myeloma patients.<br>*Identify biomarkers in circulating blood to assess the impact of new therapies on the immune response.;Primary end point(s): Increased expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.;Timepoint(s) of evaluation of this end point: 28 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Assessment of the expression of activation/maturation markers and immune checkpoints by medullary immune cell subpopulations. <br>Assessment of the expression of activation/maturation markers and immune checkpoints by medullary tumour plasma cells.<br>*Assessment of the expression of activation/maturation markers and immune checkpoints by blood immune cell subpopulations.;Timepoint(s) of evaluation of this end point: 28 days