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