E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
multiple myeloma |
multipel myeloom |
|
E.1.1.1 | Medical condition in easily understood language |
bone marrow cancer |
beenmergkanker |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Doel van het onderzoek is het bepalen van het optimale moment van vaccinatie met pneumokokkenvaccin en influenzavaccin gedurende behandeling met lenalidomide. Door middel van antilichaam titerbepalingen kan deze vraag worden beantwoord. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Het in kaart brengen van het effect van lenalidomide heeft op het immuunsysteem ten tijde van vaccinatie. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
1. Patienten met een multipel myeloma die worden behandeld met lenalidomide met/zonder steroiden. 2. Leeftijd > 18 jaar 3. Tekenen van infomed consent
Controle groep: 1. Leeftijd, geslachten en comorbiditeit gematcht 2. Age >18 years 3. Signing informed consent |
|
E.4 | Principal 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 |
1. Koorts ten tijde van vaccinatie 2. Afronding van behandeling met lenalidomide voor vaccinatie 3. bekende allergische reactie op een van de componenten van het vaccin
Controle groep: 1. gebruik van immuunsupprsiva 2. Koorts ten tijde van vaccinatie 3. Bekende allergische reactie op een van de componenten van het vaccin |
|
E.5 End points |
E.5.1 | 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. |
Antilichaam titers van influenza en pneumokokken (13 verschillende serotypes) voor en na vaccinatie. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
january 2015 |
januari 2015 |
|
E.5.2 | 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-α and IFN-g) • Complement factors |
- Immunoglobulines (IgA, IgM en IgG) en IgG subclasses - lymfocytensubsets - T-helper 17 cellen en regulatoire T-cellen - productie van IFN-gamma door CD4 T-cellen - Cytokines (TGF-β, IFN-γ, TNF-alfa, IL-6, IL-2) - complement |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
january 2015 |
januari 2015 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
vergelijking tussen vaccinatie op 2 verschillende tijdstippen. Daarnaast een controle groep bestaand |
comparison of vaccination at two different time points and a control group of healthy subject who wi |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
laatste bezoek van de laatste patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |