Status:
COMPLETED
Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders
Lead Sponsor:
Emory University
Collaborating Sponsors:
Sanofi
National Institutes of Health (NIH)
Conditions:
Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 g...
Detailed Description
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 comp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04080531
Start Date
October 18 2019
End Date
December 15 2022
Last Update
February 28 2025
Active Locations (2)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322