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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03734 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Winship4709-19 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.
PRIMARY OBJECTIVES:
I. Demonstrate an absolute 25% increase in seroprotection, defined as hemagglutination antibody inhibition (HAI) > 40 against all strains, at week 21 in the experimental arm compared to the control arm.
II. Determine correlation between HAI, predefined risk of influenza-like illness (low, moderate, high), and progression-free survival (PFS).
EXPLORATORY OBJECTIVES:
I. Measurement of B & T-cell subsets and flu-specific responses as a way of understanding immunosuppression in this patient population, correlating with influenza-like illness.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive trivalent influenza vaccine intramuscularly (IM) at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks and then periodically for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (trivalent influenza vaccine, Prevnar) | Experimental | Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. |
|
| Arm II (trivalent influenza vaccine, Prevnar) | Experimental | Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal 13-valent Conjugate Vaccine | Biological | Given IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) | HAI in blood at week 21 for all variants | 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Hofmeister, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital/Winship Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Trivalent Influenza Vaccine, Prevnar) | Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM |
| FG001 | Arm II (Trivalent Influenza Vaccine, Prevnar) | Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Trivalent Influenza Vaccine, Prevnar) | Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) | HAI in blood at week 21 for all variants | Posted | Count of Participants | Participants | 21 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Trivalent Influenza Vaccine, Prevnar) | Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig C. Hofmeister, MD, MPH | Emory University | 404-778-0519 | craig.hofmeister@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2020 | Jul 31, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2021 | Feb 12, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D007252 | Influenza Vaccines |
| C000618615 | Fluzone High-Dose |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Trivalent Influenza Vaccine | Biological | Given IM |
|
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Arm II (Trivalent Influenza Vaccine, Prevnar) |
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| 3 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Arm II (Trivalent Influenza Vaccine, Prevnar) | Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity. Pneumococcal 13-valent Conjugate Vaccine: Given IM Trivalent Influenza Vaccine: Given IM | 1 | 85 | 0 | 85 | 0 | 85 |
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