NL-OMON34204已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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®
研究者
相似试验
进行中（未招募）
不适用
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 responsMonoclonal Gammopathy of Undetermined significanceEUCTR2010-022693-14-NLuniversity medical centre groningen
尚未招募
不适用
Study to the humoral and cellular immuneresponse after influenzavaccination in patients with metastasized RCC or GIST treated with a tyrosine kinase inhibitor(sunitinib or sorafenib)kidney cancer10038363GISTNL-OMON32710niversitair Medisch Centrum Sint Radboud75
已完成
不适用
Investigation of the humoral and cellular immunity against SARS-CoV2 in patients after kidney transplantation in pandemic timesU07.1COVID-19, virus identifiedDRKS00024171niversitätsklinikum Köln46
招募中
4 期
Evaluation of vaccine response to 13-valent pneumococcal conjugate vaccine and 23-valent polysaccharide vaccine in patients living with HIV/AIDSRBR-3wshg2mHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
进行中（未招募）
不适用
Immunity and immunological memory after pneumococcal vaccination in childreEUCTR2011-002103-15-NLRIVM