EUCTR2005-003761-16-GBActive, not recruitingPhase 1
Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia - Pneumococcal conjugate vaccination in Haematology patients: Version 1
Department of R & D, Central Manchester and Manchester Children's Hospital NHS Trust0 sites97 target enrollmentStarted: October 14, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 97
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients with multiple myeloma as defined by:
- •Demonstration of:
- •- Over 10% plasma cells in the bone marrow
- •And at least one of the following:
- •- Lytic lesions on radiographic X-ray imaging
- •- A paraprotein in serum or urine
- •Patients with CLL as defined by:
- •Demonstration of:
- •- A clonal population of B-lymphocytes with characteristic immunophenotype (CD5+, CD23+, Weak SIg, FMC7-ve) in peripheral blood, bone marrow or lymph node biopsy.
- •Aged = 18 years
- •Able to give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Immunoglobulin therapy in the previous 4 months
- •General contraindications to immunisation as defined in the UK handbook Immunisation against Infectious Disease”
- •Currently receiving treatment prior to planned peripheral blood stem cell/bone marrow transplant
- •Less than 6 months post peripheral blood stem cell/bone marrow transplant
- •Receiving treatment with high dose steroids (monthly pulsed dexamethasone or > 1mg/kg of prednisolone as a continuous dose)
- •Platelets < 30x109/L
- •Prior vaccination with Prevenar
- •Prior vaccination with 23-valent pneumococcal vaccine in previous 6 months
- •Previous splenectomy
- •Other secondary immunodeficiency state e.g. HIV infection
Investigators
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