NCT02851056

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for early_phase_1 multiple-myeloma

Timeline
Completed

Started Sep 2016

Shorter than P25 for early_phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

July 28, 2016

Last Update Submit

November 10, 2022

Conditions

Multiple Myeloma

Keywords

MyelomaVaccineDendritic cellautologous hematopoietic cell transplantHCT

Outcome Measures

Primary Outcomes (2)

  • Rate of Complete Response (CR)

    Complete Response: A treatment outcome where there are ≤5% plasma cells in the bone marrow and no evidence of myeloma proteins in the serum or urine as measured by standard laboratory techniques.

    90 days post treatment

  • Number of Participants With Treatment Emergent Adverse Events

    The safety of DC:AdmS when administered to patients with myeloma before and at day +21 after autologous hematopoietic stem cell transplant. The approach for assessing potential toxicity of survivin vaccination will focus predominantly on assessing hematopoietic reconstitution, including T cell repopulation and gastrointestinal toxicity. Investigators will also monitor for autoimmune disorders involving other tissues where survivin expression has been demonstrated: these include keratinocytes and melanocytes, myocardium, liver, breast, and brain. The most sensitive test to assess the potential toxicity of survivin vaccination on hematopoietic function is the time of neutrophil repopulation after autologous stem cell transplant (ASCT). Beginning on day of ASCT, participants will be monitored daily for engraftment, defined by an absolute neutrophil count of 500 cells per microliter that is sustained for at least 3 days.

    Up to 6 months post treatment

Secondary Outcomes (1)

  • Number of Participants With Improved Immunologic Response

    180 days (6 months) post vaccination

Study Arms (1)

Survivin Vaccine and Autologous HCT

EXPERIMENTAL

Dendritic Cell Survivin Vaccine (DC:AdmS) and Autologous Hematopoietic Cell Transplantation (HCT). Participants will receive 1 pre-transplant survivin vaccine, 7-30 days prior to stem cell apheresis collection. After the first survivin vaccination, participants will be mobilized with Granulocyte-colony Stimulating Factor (G-CSF). A second survivin vaccine will be administered on day +21 (between day+20 and +34) after HCT. All participants will be co-immunized with Prevnar 13 at each time they receive the survivin vaccine.

Biological: Survivin VaccineProcedure: Autologous Hematopoietic Cell TransplantationBiological: Prevnar 13Drug: Granulocyte-colony Stimulating Factor

Interventions

Survivin VaccineBIOLOGICAL

Pre-transplant vaccination : The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, Human Leukocyte Antigen - antigen D Related (HLA-DR)+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered. Post-transplant vaccination: The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, HLA-DR+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered.

Survivin Vaccine and Autologous HCT
Autologous Hematopoietic Cell TransplantationPROCEDURE

The participant's own cells are collected from their blood, frozen, and then given back to them after they receive chemotherapy.

Also known as: HCT
Survivin Vaccine and Autologous HCT
Prevnar 13BIOLOGICAL

13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine. This vaccine will be administered intramuscular (IM) 0.5cc.

Also known as: PCV13
Survivin Vaccine and Autologous HCT
Granulocyte-colony Stimulating FactorDRUG

After the first survivin vaccination, participants will be mobilized with G-CSF.

Also known as: G-CSF
Survivin Vaccine and Autologous HCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Freeman CL, Atkins R, Varadarajan I, Menges M, Edelman J, Baz R, Brayer J, Castaneda Puglianini O, Ochoa-Bayona JL, Nishihori T, Shain KH, Shah B, Chen DT, Kelley L, Coppola D, Alsina M, Antonia S, Anasetti C, Locke FL. Survivin Dendritic Cell Vaccine Safely Induces Immune Responses and Is Associated with Durable Disease Control after Autologous Transplant in Patients with Myeloma. Clin Cancer Res. 2023 Nov 14;29(22):4575-4585. doi: 10.1158/1078-0432.CCR-22-3987.

    PMID: 37735756DERIVED

Related Links

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

13-valent pneumococcal vaccineGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Frederick Locke, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

September 27, 2016

Primary Completion

July 16, 2018

Study Completion

August 9, 2018

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

US(1)