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Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Primary Purpose

Plasma Cell Neoplasm

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pneumococcal 13-valent Conjugate Vaccine

Trivalent Influenza Vaccine

About this trial

This is an interventional prevention trial for Plasma Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria.
Both men and women of all races and ethnic groups are eligible for this study.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility.
Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have already received the seasonal influenza vaccine in the current season.
History of Guillain-Barré syndrome.
Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13).
Expected survival < 9 months.
Prisoners.

Sites / Locations

Emory University Hospital Midtown
Emory University Hospital/Winship Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I (trivalent influenza vaccine, Prevnar)

Arm II (trivalent influenza vaccine, Prevnar)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in hemagglutination antibody inhibition (HAI) from baseline

Assess change in HAI in blood from baseline compared to week 21

Secondary Outcome Measures

Time to progression (TTP)

Time to progression is defined as the time from last treatment until progression. Patients who have died without evidence of progression are censored in the TTP analysis at the time of death and patients who are alive without progression are censored at the last disease assessment.

Progression free survival (PFS)

Defined as the time from last treatment to the disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. Patients with no on-study assessment will be censored at the time of registration.

Overall survival (OS)

OS is defined as the time from randomization to death. Alive patients are censored at the date last known alive.

Full Information

NCT ID

NCT04080531

First Posted

September 4, 2019

Last Updated

April 29, 2023

Sponsor

Emory University

Collaborators

Sanofi, National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04080531

Brief Title

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Official Title

Influenza Vaccination in Plasma Cell Dyscrasias

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 18, 2019 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Sanofi, National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plasma Cell Neoplasm

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (trivalent influenza vaccine, Prevnar)

Arm Type

Experimental

Arm Description

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 Title

Arm II (trivalent influenza vaccine, Prevnar)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Pneumococcal 13-valent Conjugate Vaccine

Other Intervention Name(s)

PCV13, Prevnar 13

Intervention Description

Given IM

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine

Other Intervention Name(s)

Flu shot, Flu vaccination, Fluzone, Fluzone HD, Fluzone High-dose, Influenza Vaccine, Influenza Virus Vaccine, Trivalent, Types A and B, TIV

Intervention Description

Given IM

Primary Outcome Measure Information:

Title

Change in hemagglutination antibody inhibition (HAI) from baseline

Description

Assess change in HAI in blood from baseline compared to week 21

Time Frame

21 weeks

Secondary Outcome Measure Information:

Title

Time to progression (TTP)

Description

Time Frame

From last treatment until progression, assessed up to 2 years

Title

Progression free survival (PFS)

Description

Time Frame

From last treatment to the disease progression or death from any cause, assessed up to 2 years

Title

Overall survival (OS)

Description

OS is defined as the time from randomization to death. Alive patients are censored at the date last known alive.

Time Frame

From randomization to death, assessed up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria. Both men and women of all races and ethnic groups are eligible for this study. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility. Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients who have already received the seasonal influenza vaccine in the current season. History of Guillain-Barré syndrome. Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13). Expected survival < 9 months. Prisoners.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Hofmeister, MD, MPH

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital Midtown

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Emory University Hospital/Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

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