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

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