Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

NCT ID: NCT04080531

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2022-12-15

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pneumococcal 13-valent Conjugate Vaccine

Intervention Type: BIOLOGICAL

Given IM

Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

Given IM

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.

Group Type: EXPERIMENTAL

Pneumococcal 13-valent Conjugate Vaccine

Intervention Type: BIOLOGICAL

Given IM

Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

Given IM

Interventions

Pneumococcal 13-valent Conjugate Vaccine

Given IM

Intervention Type: BIOLOGICAL

Trivalent Influenza Vaccine

Given IM

Intervention Type: BIOLOGICAL

Other Intervention Names

PCV13; Prevnar 13; Flu shot; Flu vaccination; Fluzone; Fluzone HD; Fluzone High-dose; Influenza Vaccine; Influenza Virus Vaccine, Trivalent, Types A and B; TIV

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Craig Hofmeister

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Hofmeister, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2019-03734

Identifier Type: REGISTRY

Identifier Source: secondary_id

Winship4709-19

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00111721

Identifier Type: -

Identifier Source: org_study_id