Influenza Vaccination in Plasma Cell Dyscrasias
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)
研究概览
简要总结
This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.
详细描述
PRIMARY OBJECTIVES:
I. Demonstrate an absolute 25% increase in seroprotection, defined as hemagglutination antibody inhibition (HAI) > 40 against all strains, at week 21 in the experimental arm compared to the control arm.
II. Determine correlation between HAI, predefined risk of influenza-like illness (low, moderate, high), and progression-free survival (PFS).
EXPLORATORY OBJECTIVES:
I. Measurement of B & T-cell subsets and flu-specific responses as a way of understanding immunosuppression in this patient population, correlating with influenza-like illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria.
- •Both men and women of all races and ethnic groups are eligible for this study.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility.
- •Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have already received the seasonal influenza vaccine in the current season.
- •History of Guillain-Barré syndrome.
- •Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13).
- •Expected survival < 9 months.
- •Prisoners.
研究组 & 干预措施
Arm I (trivalent influenza vaccine, Prevnar)
Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
干预措施: Pneumococcal 13-valent Conjugate Vaccine (Biological)
Arm I (trivalent influenza vaccine, Prevnar)
Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
干预措施: Trivalent Influenza Vaccine (Biological)
Arm II (trivalent influenza vaccine, Prevnar)
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
干预措施: Pneumococcal 13-valent Conjugate Vaccine (Biological)
Arm II (trivalent influenza vaccine, Prevnar)
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
干预措施: Trivalent Influenza Vaccine (Biological)
结局指标
主要结局
Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)
时间窗: 21 weeks
HAI in blood at week 21 for all variants
次要结局
未报告次要终点
研究者
Craig Hofmeister
Principal Investigator
Emory University