Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
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.
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.
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