Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Phase 4

Completed

Interventions: Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Trivalent Influenza Vaccine

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Arm I (trivalent influenza vaccine, Prevnar)	Trivalent Influenza Vaccine	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)	Pneumococcal 13-valent Conjugate Vaccine	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.
Arm I (trivalent influenza vaccine, Prevnar)	Pneumococcal 13-valent Conjugate Vaccine	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)	Trivalent Influenza Vaccine	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.

Primary Outcome Measures

Name	Time	Method
Change in hemagglutination antibody inhibition (HAI) from baseline	21 weeks	Assess change in HAI in blood from baseline compared to week 21

Secondary Outcome Measures

Name	Time	Method
Time to progression (TTP)	From last treatment until progression, assessed up to 2 years	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.
Overall survival (OS)	From randomization to death, assessed up to 2 years	OS is defined as the time from randomization to death. Alive patients are censored at the date last known alive.
Progression free survival (PFS)	From last treatment to the disease progression or death from any cause, assessed up to 2 years	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.

Locations (2): Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, United States
Emory University Hospital Midtown
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Atlanta, Georgia, United States