Phase 2 N=122 Randomized Double-blind Treatment

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients

Influenza · Multiple Myeloma · Waldenstrom's Macroglobulinemia · Plasma Cell Disorders · MGUS

Bottom Line

View on ClinicalTrials.gov: NCT02566265 ↗

Enrolled (actual)

122

Serious AEs

7.4%

Results posted

Jan 2019

Primary outcome: Primary: Number of Participants With Treatment Failure by Primary Endpoint — 26; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fluzone High Dose Vaccine (Biological); Standard of care/Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Failure by Primary Endpoint	26; 13	—

Summary

The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season

Eligibility Criteria

Inclusion Criteria

Understand and voluntarily sign an informed consent form.
Age ≥18 years at the time of signing the informed consent form.
Diagnosis of any monoclonal gammopathy: Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active Waldenstrӧm Macroglobulinemia (WM).

Exclusion Criteria

Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.
Use of any other influenza vaccine for the 2015 to 2016 flu season.
Women who are pregnant or plan to become pregnant in the study period.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02566265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.