A study of humoral and cellular-mediated immune response in Monoclonal gammopathy of Undetermined Significance after vaccination with trivalent inactivated influenza vaccine (influvac)

Completed

Conditions: MGUS
Monoclonal gammopathy of undetermined significance
10035227

Registration Number: NL-OMON34204

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 122

Inclusion Criteria

Patients/controls
- (MGUS patients only)patients have to fulfill the diagnostic criteria for MGUS
- serum M protein<30g/L
- Clonal plasma cells in bone marrow <10%
- No myeloma related dysfunction
- No other B-cell proliferative disease
-informed consent;Multiple Myeloma inclusion criteria
- patients who fulfill the diagnostic criteria for multiple myeloma
- Monoclonal plasma cells in bone marrow >10% and/or presence of biopsy proven plasmacytoma
- Monoclonal protein present in serum and/or urine
-Myeloma related organ dysfunction
o Calcium elevation in the blood S. Calcium >10.5 mg/l or upper limit of normal
o Renal insufficiency: S. Creatinine > 2 mg/dl
o Anemia Hemoglobin < 10 g/dl or 2 g < normal
o Lytic bone lesions or osteoporosis
-Patients with stage 1 myeloma (according to the International Staging System)
o Serum β2-MG* <3.5 mg/L
o Serum albumin >=3.5 g/dl
-Informed consent

Exclusion Criteria

MGUS patients/ healthy controls
- age under 18 years
- current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment
- influenza vaccination within the 6 months prior to the study
- pregnancy
- malignancy
- known allergy to or former severe reaction following Influvac®;Multiple Myeloma Exclusion criteria
- Patients in late stage disease
- Patients who have undergone stem cell transplantation
- current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment
- pregnancy
- known allergy to or former severe reaction following Influvac®

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Humoral immune response will be determined by the Haemagluttination inhibition<br /><br>test and respose is defined by the achievement of titres >40, which are<br /><br>considered protective.<br /><br>Enzyme linked ImmunoSPOT (ELIspot) will also quantify influenza specific B cell<br /><br>response.<br /><br><br /><br>the cellular immune response will be measured by Intracellular Cytokine (i.e.<br /><br>IFN*, IL-2 and TNFa) detection by Flow Cytometry and assessment of<br /><br>proliferation of CD4 and CD8 T cells by Flow Cytometry.<br /><br><br /><br>these parameters in patients will be compared to healthy controls</p><br>

Secondary Outcome Measures