Clinical trial NCT02294487: Study of the Immune Response After Vaccination in Multiple Myeloma Patients
Official title: The Immune Response Following Vaccination in Multiple Myeloma Patients: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Myeloma, Multiple
Myeloma-Multiple
Keywords: influenza
pneumococcal
pneumonia
vaccine
immunization
#CAImmun
Immuno-oncology
supportive care
vaccination
meningococcal
HIB
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Vince Lombardi Cancer Clinic
First posted: 2014-11-19
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple myeloma patients and age and sex matched control subjects over 50 who are already planning to have the flu and/or pneumonia vaccine as part of normal care. The control group is important for comparison of age-adjusted changes in immune responses to vaccination.

Brief summary: 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: 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.

Eligibility criteria: 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

Exclusion Criteria:

- do not meet inclusion criteria

Primary outcomes:
measure: Evaluate composition of T cells, B cells, NK cell and monocyte populations from pre-vaccination though 24 weeks post-vaccination
timeFrame: 24 weeks
measure: Measure of interferon -gamma in activated T cells from pre-vaccination though 24 weeks post-vaccination
timeFrame: 24 weeks
measure: Measure of antigen specific B cells from pre-vaccination though 24 weeks post-vaccination
timeFrame: 24 weeks
measure: Total PnC-IgG, IgG2, PnC-IgG1 and IgG3 levels from pre-vaccination though 24 weeks post-vaccination
timeFrame: 24 weeks
measure: Evaluate both FcyRIIa and FcyRIII polymorphisms
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Assess outcomes of MM patients after vaccination
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Thompson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: