EUCTR2012-001813-17-GBActive, not recruitingPhase 1
Study of apoptosis related changes and endothelial responses of multiple myeloma patients treated with chemotherapy. - procoagulant mechanisms of chemotherapy in multiple myeloma
Hull and East Yorkshire Hospitals NHS Trust0 sites42 target enrollmentStarted: May 4, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients who meet the following criteria are eligible for study entry:
- •Multiple myeloma groups:
- •1.Patients with a confirmed diagnosis of symptomatic multiple myeloma based on
- •the presence of a paraprotein in serum and/or urine organ damage (e.g osseous appearances) or symptoms considered by the clinician to be related to myeloma
- •2.Patients requiring treatment for their myeloma either at presentation or at the time of relapse
- •3.Aged 18 years or greater
- •4.Provide written informed consent
- •Myeloproliferative group (Non- Myeloma Control):
- •1.Patients with myeloproliferative disorders have a known propensity to develop thromboses (non treatment related) and will serve as the positive control group for this study. There are three major categories of myeloproliferative disorders: Chronic myelocytic leukemia, polycythemia rubra vera and myelofibrosis. These patients are followed up in a regular clinic in haematology outpatients. Based on the expected age and gender distribution of the experimental group ten of these control patients will be approached for consent in to the study. The same exclusion criteria (3.1.3) as for the experimental group will be adhered to.
- •2.Aged 18 years or greater
- •3.Provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •Patients with the following characteristics are ineligible for this trial:
- •1.Patients and participants suffering from any of the following conditions known to cause elevation of microparticles (except renal disease and chronic renal failure). These include; active infection, uncontrolled hypertension, diabetes mellitus with HBA1C indicative of poor diabetic control, recent myocardial infarction < 3 months, rheumatoid arthritis or other inflammatory process in active phase (e.g psoriasis).
Investigators
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