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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


This is a pilot study to determine the safety of PCV13 administered to patients with myeloma
before and at +7 and +21 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.


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 NAT, as evaluated during pre transplant testing

- Common variable immunodeficiency or other inherited systemic immunodeficiency
syndrome

- Active 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 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

- DLCO <50 %

- LVEF <40%

- Bilirubin >2

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Efficacy

Outcome Description:

Efficacy based on immunologic response pre/post-vaccination.

Outcome Time Frame:

180 days

Safety Issue:

No

Principal Investigator

Frederick L Locke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC - 16727

NCT ID:

NCT01852591

Start Date:

February 2013

Completion Date:

February 2014

Related Keywords:

  • Multiple Myeloma
  • autologous transplant
  • multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

H.Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612