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

university medical centre groningen0 个研究点开始时间: 2010年9月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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®

发起方

university medical centre groningen