Influenza Vaccination in Plasma Cell Dyscrasias

Who is this study for? Adult patients with Plasma Cell Myeloma
What treatments are being studied? Trivalent Influenza Vaccine
Status: Completed
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Time Frame
Start Date: 2019-10-18
Completion Date: 2022-12-15
Participants
Target number of participants: 165
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Sanofi, National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: Emory University

This content was sourced from clinicaltrials.gov