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Keep this study
Lead
H. Lee Moffitt Cancer Center and Research Institute
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with confirmed multiple myeloma
Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
You may not be if
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
Clareo Health | Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
