Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Influenza Vaccination in Plasma Cell Dyscrasias

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.

Study Overview

• Status: Completed
• Conditions: Plasma Cell Neoplasm
• Intervention / Treatment: Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Trivalent Influenza Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Pneumococcal 13-valent Conjugate Vaccine; Given IM; Other Names: Prevnar 13; PCV13; Biological: Trivalent Influenza Vaccine; Given IM; Other Names: Fluzone; TIV; Fluzone HD; Flu shot; Flu vaccination; Influenza Vaccine; Influenza Virus Vaccine, Trivalent, Types A and B; Fluzone High-dose
Experimental: 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.	Biological: Pneumococcal 13-valent Conjugate Vaccine; Given IM; Other Names: Prevnar 13; PCV13; Biological: Trivalent Influenza Vaccine; Given IM; Other Names: Fluzone; TIV; Fluzone HD; Flu shot; Flu vaccination; Influenza Vaccine; Influenza Virus Vaccine, Trivalent, Types A and B; Fluzone High-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemagglutination antibody inhibition (HAI) from baseline	Assess change in HAI in blood from baseline compared to week 21	21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression (TTP)	Time to progression is defined as the time from last treatment until progression. Patients who have died without evidence of progression are censored in the TTP analysis at the time of death and patients who are alive without progression are censored at the last disease assessment.	From last treatment until progression, assessed up to 2 years
Progression free survival (PFS)	Defined as the time from last treatment to the disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. Patients with no on-study assessment will be censored at the time of registration.	From last treatment to the disease progression or death from any cause, assessed up to 2 years
Overall survival (OS)	OS is defined as the time from randomization to death. Alive patients are censored at the date last known alive.	From randomization to death, assessed up to 2 years

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI); Sanofi; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Craig Hofmeister, MD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IRB00111721; P30CA138292 (U.S. NIH Grant/Contract); NCI-2019-03734 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); Winship4709-19 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No