Multiple Myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid
Product Name: Revlimid
Pharmaceutical Form: Capsule
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
CHU Rennes
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activation of medullary lymphocytes after a lenalidomide-dexamethasone cycle in patients with newly diagnosed multiple myeloma. ;Secondary Objective: *Characterize the phenotypic modulations of the immune subpopulations induced by Lenalidomide in the marrow of multiple myeloma patients. *Characterize the phenotypic modulations of lenalidomide induced tumor plasma cells in the marrow of multiple myeloma patients. *Identify biomarkers in circulating blood to assess the impact of new therapies on the immune response.;Primary end point(s): Increased expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Assessment of the expression of activation/maturation markers and immune checkpoints by medullary immune cell subpopulations. *Assessment of the expression of activation/maturation markers and immune checkpoints by medullary tumour plasma cells. *Assessment of the expression of activation/maturation markers and immune checkpoints by blood immune cell subpopulations.;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
France
Contacts
Public ContactHaematology
CHU Rennes
Outcome results
None listed