Survivin Vaccine : Multiple Myeloma Autologous Hematopoietic Cell Transplant (HCT)

This study is designed to test the safety and efficacy of the survivin vaccine, as well as
the biological activity. A total sample size of 30 patients will be used for the study. In
the 1st stage, 10 patients will be used to evaluate the safety and futility of the vaccine.
If it passes the 1st stage, investigators will enroll another 20 patients (as 2nd stage) to
evaluate the efficacy. The two- stage experiment is based on Simon minmax two-stage design
for efficacy. Vaccine will be administered in two stages. After the first survivin
vaccination, participants will be mobilized with G-CSF and both in vivo-primed T cells and
stem cells will be collected in the same apheresis (the graft). T cells and the CD34
progenitor cells will be transferred back to the participant at the time of autologous graft
infusion. Participants will receive re-vaccination on, or near, day 21 after transplant.

Inclusion Criteria:

Screening:

- As of protocol Version 2 there is no "screening phase".Patients previously consented
to the screening phase could still be eligible for treatment if consented for
treatment, based upon the updated eligibility criteria.

Treatment:

- Patients with histologically confirmed Multiple Myeloma that are being considered for
high dose chemotherapy and autologous stem cell transplant.

- Patients must have a bone marrow biopsy available, or one scheduled to be performed
for a clinical indication so that survivin expression could be determined (note:
survivin staining in tumor need not be resulted prior to enrollment or treatment as it
is obtained for correlative science).

- Patients planned for treatment with high dose melphalan and autologous hematopoietic
cell transplant (HCT).

- Complete blood count (CBC) with an absolute neutrophil count (ANC) >= 1,000/uL,
hemoglobin >= 8.0 g/dL and platelet count >= 50,000/uL.

- Liver enzymes: total bilirubin less than or equal to 2 mg/dL (>2 mg/dL permitted if
the patient has evidence of Gilbert's disease based upon prior bilirubin elevation or
genetic testing); Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
less than 1.5 X the upper limit of normal (ULN).

- Signed informed consent form in accordance with institutional and federal law
policies.

Exclusion Criteria:

Treatment:

- Patients with Complete Response (CR) or stringent CR after induction therapy as
defined by International Response Criteria after most recent therapy.

- Patients with progressive disease at time of transplant.

- Pregnant or lactating woman (as evaluated by serum testing within 48 hours of
administration of the first vaccine in women of child bearing potential).

- HIV infection confirmed by nucleic acid tests (NAT).

- Common variable immunodeficiency.

- Active central nervous system (CNS) malignancy.

- Active bacterial, fungal or viral infection.

- Prior history of allogeneic hematopoietic cell transplantation

- 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 Prevnar or any
diphtheria-toxoid containing vaccine.