Clinical Trial Details
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NCT02851056 : Survivin Vaccine : Multiple Myeloma Autologous Hematopoietic Cell Transplant (HCT)
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:


- 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.


- 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

Exclusion Criteria:


- 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.
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