NCT04080531

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Influenza Vaccination in Plasma Cell Dyscrasias

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive trivalent influenza vaccine intramuscularly (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. ARM II: 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. After completion of study treatment, patients are followed for 4 weeks and then periodically for 2 years.

Conditions

• Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal 13-valent Conjugate Vaccine	Given IM
BIOLOGICAL	Trivalent Influenza Vaccine	Given IM

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-05-11
• Completion: 2022-12-15
• First posted: 2019-09-06
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study