Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Emory University

Status and phase: Completed; Phase 4

Conditions: Plasma Cell Neoplasm

Treatments: Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Trivalent Influenza Vaccine

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04080531

P30CA138292 (U.S. NIH Grant/Contract)

IRB00111721

NCI-2019-03734 (Registry Identifier)

Winship4709-19 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Arm I (trivalent influenza vaccine, Prevnar)

Experimental group

Description:

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.

Treatment:

Biological: Trivalent Influenza Vaccine

Biological: Pneumococcal 13-valent Conjugate Vaccine

Arm II (trivalent influenza vaccine, Prevnar)

Experimental group

Description:

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.

Treatment:

Biological: Trivalent Influenza Vaccine

Biological: Pneumococcal 13-valent Conjugate Vaccine