Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia
- Conditions
- Multiple myeloma and chronic lymphocytic leukaemiaCancerMyeloma and chronic lymphocytic leukaemia
- Registration Number
- ISRCTN21541376
- Lead Sponsor
- Central Manchester and Manchester Children's Hospital (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 97
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
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
11. Other secondary immunodeficiency state e.g. Human Immunodeficiency Virus (HIV) infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method