Multiple Myeloma
Conditions
Keywords
autologous transplant, multiple myeloma
Brief summary
There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.
Detailed description
This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT.
Interventions
BIOLOGICALPCV 13
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed multiple myeloma * Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
Exclusion criteria
* Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine * HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing * Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome * Active central nervous system (CNS) malignancy * Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy. * History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine. * Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation * Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician * Active or uncontrolled infection * Diffusing lung capacity oxygenation (DLCO) \<50 % * Left ventricular ejection fraction (LVEF) \<40% * Bilirubin \>2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Immune Response | 30 Days Post Vaccine | Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | 30 Days Post Vaccine | Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. |
| CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | 30 Days Post Vaccine | Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30. |
| CD8+CD107a+, Best Response Against Vaccine (CRM 197) | 30 Days Post Vaccine | Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at Moffitt Cancer Center between March 2013 and July 2014.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: PCV 13 Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not Evaluable at Time of Analysis | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Experimental: PCV 13 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 61.625 years |
| Gender Female | 2 Participants |
| Gender Male | 6 Participants |
| Region of Enrollment United States | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 3 / 7 |
Outcome results
Primary
Number of Participants With Immune Response
Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.
Time frame: 30 Days Post Vaccine
Population: All evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: PCV 13 | Number of Participants With Immune Response | CD4+CTV-IFN-gamma+, | 5 participants |
| Experimental: PCV 13 | Number of Participants With Immune Response | CD8+CTV-IFN-gamma+, | 5 participants |
| Experimental: PCV 13 | Number of Participants With Immune Response | CD8+CD107a+ | 5 participants |
Secondary
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.
Time frame: 30 Days Post Vaccine
Population: All evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: PCV 13 | CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Highest % of CD4 cells Pre-vaccine | 0.051 percentage of CD4 cells |
| Experimental: PCV 13 | CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Best Response % of CD4 cells Day +30 | 40.7 percentage of CD4 cells |
Secondary
CD8+CD107a+, Best Response Against Vaccine (CRM 197)
Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry.
Time frame: 30 Days Post Vaccine
Population: All evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: PCV 13 | CD8+CD107a+, Best Response Against Vaccine (CRM 197) | Highest % of CD8 cells Pre-vaccine | 1.19 percentage of CD8 cells |
| Experimental: PCV 13 | CD8+CD107a+, Best Response Against Vaccine (CRM 197) | Best Response % of CD8 cells Day +30 | 8.94 percentage of CD8 cells |
Secondary
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30.
Time frame: 30 Days Post Vaccine
Population: All evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: PCV 13 | CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Highest % of CD8 cells Pre-vaccine | 0.00 percentage of CD8 cells |
| Experimental: PCV 13 | CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Best Response % of CD8 cells Day +30 | 2.69 percentage of CD8 cells |