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OpenTrials
Completed

NCT Number: NCT04872023

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood and bone marrow sampling

Other

Blood and bone marrow sampling

Primary outcomes

  1. Rate of HLA-DR on medullary T-lymphocytes

    Time frame: 1 month

    Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.

Secondary outcomes

  1. Activation status of biological markers

    Time frame: 1 month

    Presence of active protein markers and immune checkpoints by medullary immune cell subpopulations.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint

Acronym: IMMUNO-MYELO

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 4, 2021
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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