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

Trial Status: Temporarily Closed to Accrual

This early phase I studies the side effects of dendritic cell survivin vaccine and how well it works in treating patients with multiple myeloma who are undergoing stem cell transplant. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells.

Inclusion 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 are planned for treatment with high dose melphalan and autologous hematopoietic cell transplantation (HCT)
  • Absolute neutrophil count (ANC) >= 1,000/uL
  • Hemoglobin >= 8.0 g/dL
  • Platelet count >= 50,000/uL
  • 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
  • Signed informed consent form in accordance with institutional and federal law policies

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)
  • Human immunodeficiency virus (HIV) infection confirmed by nucleic acid testing (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

Florida

Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Frederick Lundry Locke
Phone: 813-745-7208

PRIMARY OBJECTIVES:

I. Determine the safety of DC:AdmS (dendritic cell survivin vaccine) when administered to patients with myeloma before and around day +21 after autologous hematopoietic stem cell transplant.

II. Evaluate the ability of DC:AdmS to induce T cell immune responses against survivin when administered to patients with myeloma before and at day +21 after autologous hematopoietic stem cell transplant.

OUTLINE:

Patients receive first dose dendritic cell survivin vaccine intradermally (ID) 7-30 days before apheresis collection and second dose 20-34 days following stem cell transplantation in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 60, 90, and 180 days.

Trial Phase Phase O

Trial Type Treatment

Lead Organization
Moffitt Cancer Center

Principal Investigator
Frederick Lundry Locke

  • Primary ID MCC-18346
  • Secondary IDs NCI-2016-01324
  • Clinicaltrials.gov ID NCT02851056