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

NCT04872023 | Completed

• 1 other identifier: 35RC17_8825_IMMUNOMYELO
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Activation status of biological markers

  1 month

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

Blood and bone marrow sampling OTHER

Blood and bone marrow sampling

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: July 29, 2021
• Primary Completion: June 13, 2022
• Study Completion: January 27, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)