NCT04080531 · REGISTRY CONDITION SEARCH

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2025-02-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Trivalent Influenza Vaccine
label
Arm I (trivalent influenza vaccine, Prevnar)
type
EXPERIMENTAL
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.
intervention Names
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Trivalent Influenza Vaccine
label
Arm II (trivalent influenza vaccine, Prevnar)
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I (trivalent influenza vaccine, Prevnar)
Arm II (trivalent influenza vaccine, Prevnar)
description
Given IM
name
Pneumococcal 13-valent Conjugate Vaccine
other Names
PCV13
Prevnar 13
type
BIOLOGICAL
arm Group Labels
Arm I (trivalent influenza vaccine, Prevnar)
Arm II (trivalent influenza vaccine, Prevnar)
description
Given IM
name
Trivalent Influenza Vaccine
other Names
Flu shot
Flu vaccination
Fluzone
Fluzone HD
Fluzone High-dose
Influenza Vaccine
Influenza Virus Vaccine, Trivalent, Types A and B
TIV
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

PREVENTION

Enrollment

count: 165
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
HAI in blood at week 21 for all variants
measure
Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)
time Frame
21 weeks

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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query cond
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice