Viewing Study NCT04872023



Ignite Creation Date: 2024-05-06 @ 4:07 PM
Last Modification Date: 2024-10-26 @ 2:03 PM
Study NCT ID: NCT04872023
Status: COMPLETED
Last Update Posted: 2023-02-03
First Post: 2021-04-28

Brief Title: Immunomonitoring and Multiple Myeloma Impact of Lenalidomide on Immune Checkpoint Expression
Sponsor: Rennes University Hospital
Organization: Rennes University Hospital

Study Overview

Official Title: Immunomonitoring and Multiple Myeloma Impact of Lenalidomide on Immune Checkpoint
Status: COMPLETED
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IMMUNO-MYELO
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 predictmonitor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None