NCT01852591

Brief Summary

There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable multiple-myeloma

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable 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

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

May 9, 2013

Results QC Date

January 28, 2016

Last Update Submit

December 7, 2016

Conditions

Multiple Myeloma

Keywords

autologous transplantmultiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Immune Response

    Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.

    30 Days Post Vaccine

Secondary Outcomes (3)

  • CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

    30 Days Post Vaccine

  • CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

    30 Days Post Vaccine

  • CD8+CD107a+, Best Response Against Vaccine (CRM 197)

    30 Days Post Vaccine

Study Arms (1)

PCV 13

EXPERIMENTAL

Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant

Biological: PCV 13

Interventions

PCV 13BIOLOGICAL
Also known as: Prevnar, pneumococcal conjugate vaccine
PCV 13

Eligibility Criteria

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

You may qualify if:

  • Patients with confirmed multiple myeloma
  • Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant

You may not qualify if:

  • Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine
  • HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing
  • Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
  • Active central nervous system (CNS) malignancy
  • 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 pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
  • Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
  • Active or uncontrolled infection
  • Diffusing lung capacity oxygenation (DLCO) \<50 %
  • Left ventricular ejection fraction (LVEF) \<40%
  • Bilirubin \>2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H.Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

13-valent pneumococcal vaccineHeptavalent Pneumococcal Conjugate VaccinePneumococcal Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Results Point of Contact

Title
Frederick Locke, M.D.
Organization
H. Lee Moffitt Cancer Center and Research Institute
frederick.locke@moffitt.org
813-745-3509

Study Officials

  • Frederick L Locke, MD

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 13, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

October 1, 2016

Last Updated

February 2, 2017

Results First Posted

April 4, 2016

Record last verified: 2016-12

Locations

US(1)