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Virus Therapy

Flu Vaccine for Multiple Myeloma

Phase 4

Waitlist Available

Led By Craig Hofmeister, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility.

Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death, assessed up to 2 years

Awards & highlights

Study Summary

This trial studies how well the flu vaccine works in preventing infections in patients with plasma cell disorders. The flu vaccine may help improve the status of patients' plasma cell disorder.

Who is the study for?

This trial is for men and women with plasma cell disorders like multiple myeloma, who can sign consent forms. They should fit specific diagnostic criteria, be able to perform daily activities (ECOG ≤ 3), and be eligible for standard flu shots. People with severe egg allergies or past bad reactions to vaccines, prisoners, those already vaccinated this season, Guillain-Barré syndrome history, or expected survival under 9 months cannot join.Check my eligibility

What is being tested?

The study is testing if the influenza vaccine can prevent flu infections in patients with plasma cell disorders. It's checking whether better protection against the flu might help control their disorder by reducing complications like infections and hospitalizations.See study design

What are the potential side effects?

Possible side effects from the vaccines may include allergic reactions such as swelling or breathing difficulties especially in those with egg allergies; however facilities are prepared for severe reactions. Other common side effects could include soreness at injection site, fever, fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can care for myself but may spend a good part of the day in bed or sitting.

Select...

My condition meets the criteria for a plasma cell disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hemagglutination antibody inhibition (HAI) from baseline

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

Time to progression (TTP)

Side effects data

From 2013 Phase 4 trial • 300 Patients • NCT01859143

Nasal congestion

Sinus congestion

Upper respiratory tract infection

Sneezing

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

TRIVALENT VACCINE

PLACEBO

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (trivalent influenza vaccine, Prevnar)Experimental Treatment2 Interventions

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.

Group II: Arm I (trivalent influenza vaccine, Prevnar)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pneumococcal 13-valent Conjugate Vaccine

2019

Completed Phase 4

~4440

Trivalent Influenza Vaccine

2010

Completed Phase 4

~2630