Clinical trial NCT01852591: Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Official title: Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: autologous transplant
multiple myeloma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Detailed description: This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.
* Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation
* 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

Primary outcomes:
measure: Number of Participants With Immune Response
timeFrame: 30 Days Post Vaccine
Secondary outcomes:
measure: CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
timeFrame: 30 Days Post Vaccine
measure: CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
timeFrame: 30 Days Post Vaccine
measure: CD8+CD107a+, Best Response Against Vaccine (CRM 197)
timeFrame: 30 Days Post Vaccine
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H.Lee Moffitt Cancer Center & Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Frederick L Locke, MD
role: PRINCIPAL_INVESTIGATOR
References: