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

Overview

The purpose of this study is to test what effects (good and bad) a new cancer vaccine will have on participants and their cancer, when administered before and after their autologous hematopoietic cell transplant (HCT). The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC:AdmS). The vaccine is made using the participant's own blood cells. The vaccine will contain a virus called an adenovirus, similar the virus that causes the common cold. The virus has been changed so it cannot infect humans and cause infections. The vaccine will be prepared at Moffitt Cancer Center in the Cell Therapy Laboratory Facility.

SparkCures ID 825
Trial Phase Pilot Trial
Enrollment 10 Patients
Treatments
Trial Sponsors
  • Moffitt Cancer Center
NCT Identifier

NCT02851056

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

Screening:

  • Patients with histologically confirmed Multiple Myeloma that could be eligible for high dose chemotherapy and autologous stem cell transplant in the future will be considered. Patients must have a bone marrow biopsy available, or one scheduled to be performed for a clinical indication. (Patients that have been treated with an induction regimen are eligible for this phase of study).

Treatment:

  • Patients enrolled in screening phase of study.
  • Expression of survivin in plasma cells by immunohistochemistry.
  • 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.

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Florida

Resources

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