multiple myeloma
Conditions
Interventions
Trade Name: Prevnar 13
Product Name: Prevnar 13
Product Code: RVG 25853
Pharmaceutical Form: Solution for injection
Trade Name: Influenza vaccine (Influvac or Vaxigrip)
Product Name: Influvac or Vaxi
Sponsors
St. Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with multiple myeloma who are treated with lenalidomide with/without steroids. 2. Age > 18 years 3. Signing informed consent. Control group: 1. Age, sex and co-morbity matched 2. Age >18 years 3. Signing informed consent 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Fever at time of vaccination 2. Completion of Lenalidomide therapy prior to vaccination 3. previous/known allergic reaction to any of the components of the influenzavaccin given Control group: 1. Use of immune supressive drugs 2. Fever at time of vaccination 3. Previous/known allergic reaction to any of the components of the influenzavaccin given
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the number of responders to vaccination with the influenza virus vaccine and pneumococcal vaccine at different time points in treatment cycle of lenalidomide. ;Secondary Objective: Secondary objective is to study the immune-response to vaccination, during treatment with lenalidomide with/without steroids and/or chemotherapy in relation to the immunesystem.;Primary end point(s): Antibody titres against the influenza virus vaccine and different serotypes of s.pneumoniae before and after vaccination. Titres will be interpreted and classified in responder or non-responder.;Timepoint(s) of evaluation of this end point: january 2015 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Immunoglobulin levels and subclasses. • Lymphocyte subsets (number of B cells T cells, CD3, CD4, CD8 and NK cells). • Different types of T cells (Th17 cells, regulatory T cells) • Production of IFN-g by CD4+ cells. This will be measured in order to investigate if cellular mediated immune responses are intact during lenalidomide treatment. • Cytokines (for example interleukin 2 and 6, TNF-a and IFN-g) • Complement factors;Timepoint(s) of evaluation of this end point: january 2015 | — |
Countries
Netherlands
Contacts
Public ContactO. de Weerdt
St. Antonius Hospital
Outcome results
None listed