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NCT02566265 · REGISTRY CONDITION SEARCH

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-01-30

The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season

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

Number of Participants With Treatment Failure by Primary Endpoint

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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: * Understand and voluntarily sign an informed consent form. * Age ≥18 years at the time of signing the informed consent form. * Diagnosis of any monoclonal gammopathy: Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active Waldenstrӧm Macroglobulinemia (WM). Exclusion Criteria: * Any serious egg allergy or prior serious adverse reaction to an influenza vaccine. * Use of any other influenza vaccine for the 2015 to 2016 flu season. * Women who are pregnant or plan to become pregnant in the study period.
healthy Volunteers
false
maximum Age
90 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.
    intervention Names
    1. Biological: Fluzone High Dose Vaccine
    label
    Fluzone High Dose Vaccine then Fluzone High Dose Booster
    type
    EXPERIMENTAL
  2. description
    Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.
    intervention Names
    1. Biological: Standard of care/Placebo
    label
    Standard of Care
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Fluzone High Dose Vaccine then Fluzone High Dose Booster
    name
    Fluzone High Dose Vaccine
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Standard of Care
    name
    Standard of care/Placebo
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
primary Purpose
TREATMENT
Enrollment
count
122
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.
    measure
    Number of Participants With Treatment Failure by Primary Endpoint
    time Frame
    1 year
Full study description
brief Summary
The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season
detailed Description
Influenza is a major cause of morbidity in the US. Patients with monoclonal gammopathies are known to have increased risk of developing influenza. Furthermore, several of the medications (such as proteasome inhibitors), commonly used to treat these tumors, are known to further increase the risk of these tumors. Seasonal influenza vaccination has been shown to reduce influenza related morbidity and is approved for routine prophylaxis in US. In 2009, Fluzone® high- dose vaccine was FDA approved in 2009 for adults aged 65 and older based on the data regarding higher rates of seroprotection (defined as hemagglutination antibody inhibition (HAI) titer of 40 or higher). In this study, the investigators will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies irrespective of age versus a standard of care control group. Primary endpoint is composite of documented influenza infection rate and disease progression (as defined by International Myeloma Working Group criteria) at the end of the flu season. Based on the background data, the investigators expect a higher rate of success in the experimental arm. As such, the investigators power for success rates of 90% and 70% in the experimental and control arms, respectively. The investigators will also analyze several secondary endpoints including rates of influenza related morbidity, the analysis of humoral and cellular immune response to these vaccines and the rate of disease control (defined as lack of disease progression by standard international myeloma working group criteria).
Source references
references
  1. citation
    Branagan AR, Duffy E, Gan G, Li F, Foster C, Verma R, Zhang L, Parker TL, Seropian S, Cooper DL, Brandt D, Kortmansky J, Witt D, Ferencz TM, Dhodapkar KM, Dhodapkar MV. Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias. Blood Adv. 2021 Mar 9;5(5):1535-1539. doi: 10.1182/bloodadvances.2020003880.
    pmid
    33683337
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      payload
      clinical indication matching status
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      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT02566265
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice