Study of the Immune Response After Vaccination in Multiple Myeloma Patients

NCT ID: NCT02294487

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-30

Study Completion Date

2017-08-10

Brief Summary

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This study will collect blood samples from healthy volunteers and volunteers with multiple myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus vaccines.

The main goal of the study is to start to identify differences in the immune response between multiple myeloma patients and people who don't have multiple myeloma. We hope this will provide important information about the best way and time to vaccinate multiple myeloma patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .

Detailed Description

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This study will consist of a prospective blood sample collection to gather baseline data to confirm antibody protection from vaccines in the Aurora Health Care multiple myeloma (MM) patients.

The overall goal of this study is to obtain a normative dataset for MM patients and non-MM control populations as well as determining baseline IgG levels to seasonal influenza A, influenza B, pneumococcal polysaccharide, and tetanus toxoid and confirmation of antibody protection from vaccines with assays based upon WHO standards of detection.

This is part of a series of studies designed to provide important information about the best way and time to vaccinate MM patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus and to gather additional information about MM and immune function.

Conditions

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Multiple Myeloma Myeloma, Multiple Myeloma-Multiple

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects

Individuals over 50 who are going to get the seasonal flu vaccine, pneumococcal, HIB, and/or meningococcal vaccination and either have multiple myeloma or do not have multiple myeloma.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 50 years old or over
* planning on getting the seasonal flu and/or pneumonia vaccine as part of normal care
* have multiple myeloma, or don't have multiple myeloma and want to serve as a health control
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vince Lombardi Cancer Clinic

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Thompson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Aurora Health Care

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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MMvax-pilot

Identifier Type: -

Identifier Source: org_study_id

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