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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04872023
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rennes University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Other: - Blood and bone marrow sampling

Blood and bone marrow sampling

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Rennes, Rennes, France

Status

Recruiting

Address

CHU Rennes

Rennes, ,

Site Contact

Olivier Decaux

olivier.decaux@chu-rennes.fr

2 99 28 76 92