Back to resultsImmunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression (IMMUNO-MYELO)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and bone marrow sampling
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
- CHU Rennes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
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
Outcomes
Primary Outcome Measures
Rate of HLA-DR on medullary T-lymphocytes
Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.
Secondary Outcome Measures
Activation status of biological markers
Presence of active protein markers and immune checkpoints by medullary immune cell subpopulations.
Full Information
NCT ID
NCT04872023
First Posted
April 28, 2021
Last Updated
February 2, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04872023
Brief Title
Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression
Acronym
IMMUNO-MYELO
Official Title
Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
January 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Blood and bone marrow sampling
Intervention Description
Blood and bone marrow sampling
Primary Outcome Measure Information:
Title
Rate of HLA-DR on medullary T-lymphocytes
Description
Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Activation status of biological markers
Description
Presence of active protein markers and immune checkpoints by medullary immune cell subpopulations.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression
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