Multiple MyelomaPCV13NCT01852591
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
A study testing PCV 13 in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PCV 13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed multiple myeloma
- Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
H.Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- PCV 13
- Keywords
- autologous transplant, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV 13Biological
Also called Prevnar, pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| PCV 13 | Experimental | 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 Receives: Biological: PCV 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days Post Vaccine
Secondary outcomes (3)
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.
Measured: 30 Days Post Vaccine
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.
Measured: 30 Days Post Vaccine
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.
Measured: 30 Days Post Vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick L Locke, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852591
- Sponsor's protocol ID
- MCC-16727
- Acronym
- PCV13
- Status last verified
- Dec 2016
- First submitted
- 9 May 2013
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01852591
- Acronym / sponsor ID
- PCV13 / MCC-16727
- Conditions
- Multiple Myeloma
- Keywords
- autologous transplant, multiple myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCV 13 | Experimental | Biological: PCV 13Pneumococcal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed multiple myeloma
- Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV 13Also: Prevnar, pneumococcal conjugate vaccine | Biological | PCV 13 |
Primary outcome
Number of Participants With Immune Response
Time frame: 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.
3 secondary outcomes
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Time frame: 30 Days Post Vaccine
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Time frame: 30 Days Post Vaccine
CD8+CD107a+, Best Response Against Vaccine (CRM 197)
Time frame: 30 Days Post Vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- H.Lee Moffitt Cancer Center \& Research InstituteLink provided by the sponsor.
- Bone Marrow Transplantation advance online publication 12 October 2015; doi: 10.1038/bmt.2015.239Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick L Locke, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCV 13 in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Immune Response (time frame: 30 Days Post Vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.