Clinical trial · Observational
Study of the Immune Response After Vaccination in Multiple Myeloma Patients
The Immune Response Following Vaccination in Multiple Myeloma Patients: A Prospective Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myeloma, Multiple | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Subjects
- description
- 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.
Primary outcomes (5)
- measure
- Evaluate composition of T cells, B cells, NK cell and monocyte populations from pre-vaccination though 24 weeks post-vaccination
- timeFrame
- 24 weeks
- description
- 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.
- measure
- Measure of interferon -gamma in activated T cells from pre-vaccination though 24 weeks post-vaccination
- timeFrame
- 24 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available