Phase 4
N=165
Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders
Plasma Cell Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT04080531 ↗Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) — 32; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pneumococcal 13-valent Conjugate Vaccine (Biological); Trivalent Influenza Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) |
32; 22 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04080531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.