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

Conditions: Monoclonal Gammopathy of Undetermined significance
MedDRA version: 12.1Level: LLTClassification code 10027522Term: MGUS
MedDRA version: 12.1Level: HLTClassification code 10022005Term: Influenza viral infections

Registration Number: EUCTR2010-022693-14-NL

Lead Sponsor: university medical centre groningen

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

MGUS 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
oCalcium elevation in the blood S. Calcium >10.5 mg/l or upper limit of normal
oRenal insufficiency: S. Creatinine > 2 mg/dl
oAnemia Hemoglobin < 10 g/dl or 2 g < normal
oLytic bone lesions or osteoporosis
-Patients with stage 1 myeloma (according to the International Staging System)
oSerum ß2-MG* <3.5 mg/L
oSerum albumin =3.5 g/dl
-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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

MGUS Patients/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®