ISRCTN21541376
Completed
未知
Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia
Central Manchester and Manchester Children's Hospital (UK)0 sites97 target enrollmentMarch 14, 2006
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Central Manchester and Manchester Children's Hospital (UK)
- Enrollment
- 97
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with multiple myeloma as defined by the demonstration of:
- •1\. Over 10% plasma cells in the bone marrow and at least one of the following:
- •a. Lytic lesions on radiographic X\-ray imaging
- •b. A paraprotein in serum or urine
- •2\. Patients with Chronic Lymphocytic Leukemia (CLL) as defined by the demonstration of a clonal population of B\-lymphocytes with characteristic immunophenotype (CD5\+, CD23\+, weak expression of surface Ig (weak SIg), FMC7\-negative) in peripheral blood, bone marrow or lymph node biopsy
- •3\. Aged \=18 years
- •4\. Ability to give written informed consent
Exclusion Criteria
- •1\. Immunoglobulin therapy in the previous four months
- •2\. General contraindications to immunisation as defined in the UK handbook \- Immunisation against Infectious Disease
- •3\. Currently receiving treatment prior to planned peripheral blood stem cell or bone marrow transplant
- •4\. Less than six months post peripheral blood stem cell or bone marrow transplant
- •5\. Receiving treatment with high dose steroids (monthly pulsed dexamethasone or \>1 mg/kg of prednisolone as a continuous dose)
- •6\. Platelets \<30 x 10^9 /l
- •7\. Prior vaccination with Prevenar
- •8\. Prior vaccination with 23\-valent pneumococcal vaccine in previous six months
- •9\. Pregnancy
- •10\. Previous splenectomy
Outcomes
Primary Outcomes
Not specified
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Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia - Pneumococcal conjugate vaccination in Haematology patients: Version 1Pneumococcal disease is a common form of meningitis, septicaemia and pneumonia. Those individuals at highest risk include children, the elderly and persons whose immune systems are impaired. This latter group is diverse includes patients with the haematological disorders myeloma and chronic lymphocytic leukaemia in whom infections are a leading cause of death.EUCTR2005-003761-16-GBDepartment of R & D, Central Manchester and Manchester Children's Hospital NHS Trust97
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