Status:
COMPLETED
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 quanti...
Eligibility Criteria
Inclusion
- Patients with confirmed multiple myeloma
- Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01852591
Start Date
February 1 2013
End Date
October 1 2016
Last Update
February 2 2017
Active Locations (1)
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1
H.Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612