An observational study in Multiple Myeloma, Myeloma, Multiple and Myeloma-Multiple, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Wake Forest University Health Sciences · Observational
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 .
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.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 19 is below the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- do not meet inclusion criteria
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.
Evaluate composition of T cells, B cells, NK cell and monocyte populations from pre-vaccination though 24 weeks post-vaccination
Evaluate composition of T cells, B cells, NK cell and monocyte populations to identify immune suppression. Multiparameter flow cytometer will be used to evaluate T cells, B cells, and NK cell and monocyte populations using differentiation markers for the cell populations in subjects at five time points, baseline to 24 weeks.
Time frame: 24 weeks
Measure of interferon -gamma in activated T cells from pre-vaccination though 24 weeks post-vaccination
Measure of interferon -gamma in activated T cells to evaluate T cell function. An intracellular interferon-gamma assay will be performed by incubating peripheral blood mononuclear cells overnight with an influenza antigen and evaluating the level of an intracellular interferon-y assay will be performed by incubating peripheral blood mononuclear cells overnight with an influenza antigen and evaluating the level of interferon -gamma in activated T cells. Vaccination should increase numbers of T cells producing interferon -gamma. Vaccination should increase numbers of T cells producing interferon -gamma.This evaluation will be done using blood drawn at 5 time points, including pre-vaccination and post vaccination at 2, 4, 12 and 24 weeks.
Time frame: 24 weeks
Measure of antigen specific B cells from pre-vaccination though 24 weeks post-vaccination
Measure of antigen specific B cells to determine B cell responsiveness to the pneumococcal vaccine. Polysaccharides from various pathogenic strains will be conjugated to a fluorescent molecule such as fluorescein isothiocyanate (FITC). These constructs will be combined with B cell markers to evaluate pneumococcal specific B cells pre- and post-vaccination. If vaccination is successful, there should be an increase in antigen specific B cells.
Time frame: 24 weeks
Total PnC-IgG, IgG2, PnC-IgG1 and IgG3 levels from pre-vaccination though 24 weeks post-vaccination
Total PnC-IgG levels and IgG2 levels will be determined by EIA using commercially available, FDA cleared kits (The Binding Site). PnC-IgG1 and IgG3 levels will be measured by ELISA using commercially available kits that we will modify in-house with optimized reagents for detection of IgG1 and IgG3 isotopes, standardized against a reference serum. This evaluation will be done using blood drawn at 5 time points, including pre-vaccination and post vaccination at 2, 4, 12 and 24 weeks.
Time frame: 24 weeks
Evaluate both FcyRIIa and FcyRIII polymorphisms
Effectiveness of pneumococcal vaccines has an association with FcyRIIa that is expressed predominantly on phagocytic cells such as neutrophils and macrophages. There are no reports that suggest polymorphisms in FcyRIII are associated with improved efficacy of pneumococcal vaccines. However, therapeutic antibodies for the treatment of cancer such as rituximab have demonstrated that there is a survival advantage of individuals that have the FcyRIIa (H131R) and FcyRIII (V158F) polymorphisms. By evaluating both FcyRIIa and FcyRIII we can position ourselves to evaluate the use of vaccines and therapeutics in cancer.
Time frame: up to 24 weeks
Assess outcomes of MM patients after vaccination
Long term outcomes data will be collected from the medical record of MM patients in order to access the impact of vaccination on health outcomes.
Time frame: up to 10 years
Ran from Dec 2014 to primary completion in Jan 2016, 12 months.
Of 175 non-industry observational studies under Multiple Myeloma, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 33. This study's 12 months is below that.
Counting every sponsor, half of 238 studies reached it within 61 months; a quarter within 31 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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