Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression (IMMUNO-MYELO)

Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Blood and bone marrow sampling

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • Chu Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients; 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	Other: Blood and bone marrow sampling; Blood and bone marrow sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of HLA-DR on medullary T-lymphocytes	Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activation status of biological markers	Presence of active protein markers and immune checkpoints by medullary immune cell subpopulations.	1 month

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 29, 2021
• Primary Completion (ACTUAL): June 13, 2022
• Study Completion (ACTUAL): January 27, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (ACTUAL): May 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 35RC17_8825_IMMUNOMYELO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No