Multiple myeloma and chronic lymphocytic leukaemia Cancer Myeloma and chronic lymphocytic leukaemia
Conditions
Interventions
All study participants will be required to undertake three or four scheduled visits. If the patient is being seen regularly for follow up in the clinic, the trial visits will be scheduled to coincide
Sponsors
Central Manchester and Manchester Children's Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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 11. Other secondary immunodeficiency state e.g. Human Immunodeficiency Virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether the pneumococcal conjugate vaccine (Prevenar) can provide immunity from invasive pneumococcal disease in a group of haematology patients at high risk of infective complications | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether the immune response to the conjugate vaccine (Prevenar) differs between individuals naive to the 23-valent pneumococcal vaccine and those who have received at least one previous dose 2. To assess whether the response to subsequent vaccination with the 23-valent polysaccharide vaccine is enhanced by prior vaccination with the conjugate vaccine (Prevenar) 3. To determine the optimum dosage and schedule of the conjugate vaccine 4. To evaluate the immune response in relation to disease related variables. These will include disease stage, treatment and laboratory markers of the immune system function as a whole. This will improve our understanding of the mechanisms resulting in vaccine success and failure. | — |
Countries
United Kingdom
Outcome results
None listed