Reponse to vaccination in patients with bonemarrowcancer who are treated with chemotherapy.

Conditions: multiple myeloma
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2012-005713-39-NL

Lead Sponsor: St. Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): • Immunoglobulin levels and subclasses.<br>• Lymphocyte subsets (number of B cells T cells, CD3, CD4, CD8 and NK cells).<br>• Different types of T cells (Th17 cells, regulatory T cells)<br>• 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.<br>• Cytokines (for example interleukin 2 and 6, TNF-a and IFN-g)<br>• Complement factors;Timepoint(s) of evaluation of this end point: january 2015