Plasma Cell Neoplasm
Conditions
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.
Interventions
BIOLOGICALPneumococcal 13-valent Conjugate Vaccine
Given IM
BIOLOGICALTrivalent Influenza Vaccine
Given IM
Sponsors
Sanofi
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) | 21 weeks | HAI in blood at week 21 for all variants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM | 80 |
| 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.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM | 85 |
| Total | 165 |
Baseline characteristics
| Characteristic | Arm II (Trivalent Influenza Vaccine, Prevnar) | Arm I (Trivalent Influenza Vaccine, Prevnar) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 34 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 46 Participants | 93 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 9.68 | 61.7 years STANDARD_DEVIATION 11.6 | 62.35 years STANDARD_DEVIATION 10.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 70 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 22 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 54 Participants | 51 Participants | 105 Participants |
| Region of Enrollment United States | 85 participants | 80 participants | 165 participants |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 67 Participants |
| Sex: Female, Male Male | 55 Participants | 43 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 80 | 1 / 85 |
| other Total, other adverse events | 0 / 80 | 0 / 85 |
| serious Total, serious adverse events | 0 / 80 | 0 / 85 |
Outcome results
Primary
Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)
HAI in blood at week 21 for all variants
Time frame: 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Trivalent Influenza Vaccine, Prevnar) | Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) | 32 Participants |
| Arm II (Trivalent Influenza Vaccine, Prevnar) | Seroprotection Based on Hemagglutination Antibody Inhibition (HAI) | 22 Participants |