Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: Blood and bone marrow sampling

• Registration Number: NCT04872023
• Lead Sponsor: Rennes University Hospital

Brief Summary

The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.

This study will provide rational guidance for future combination therapies with lenalidomide.

Detailed Description

With the significant increase in the number of therapeutic combinations targeting the tumour microenvironment, it is crucial to better understand the effect of reference myeloma treatments on the different immune populations present in the tumour in order to rationally optimise the combination with new strategies under development. In addition, the identification of biomarkers in the circulating blood that can predict/monitor the impact of new therapies on the immune response is a major challenge.

This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-04
• Study Start: 2021-07-29
• Primary Completion: 2022-06-13
• Study Completion: 2023-01-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Blood and bone marrow sampling	All patients will have a extra blood sampling before first cycle of treatment and after one cycle. They also have an extra bone marrow sampling after the first cycle of treatment

Primary Outcome Measures

Name	Time	Method
Rate of HLA-DR on medullary T-lymphocytes	1 month	Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.

Secondary Outcome Measures

Name	Time	Method
Activation status of biological markers	1 month	Presence of active protein markers and immune checkpoints by medullary immune cell subpopulations.

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France