Chemotherapy related thrombosis in patients treated for multiple myeloma. MedDRA version: 14.1 Level: LLT Classification code 10021182 Term: Iatrogenic pulmonary embolism and infarction System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10013878 Term: DVT of calf
Conditions
Interventions
Trade Name: Revlimid
Product Name: Revlimid
Pharmaceutical Form: Tablet
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the disruption of the endothelium, platelets and the clotting cascade caused by the novel chemotherapeutic combinations used for the treatment of multiple myeloma.;Secondary Objective: To correlate clinically evident thromboembolism (TE) with the type of treatment received and laboratory findings.; Primary end point(s): The primary outcomes relate to identifying laboratory proof of the disruption of the endothelium, platelets and the coagulation cascade caused by bio- chemotherapeutic combinations used for the treatment of multiple myeloma. Baseline values of the biomarkers of coagulation (and EndoPAT) being studied will be compared to values at later time points while on treatment and to the values obtained from control groups. Without prior art it is not possible to define the size of statistical samples so the numbers studied have been dictated by the numbers of patients one would expect to see during the length of the PhD. | — |
Countries
United Kingdom
Contacts
Public ContactDr A Maraveyas
Hull and East Yorkshire Hospitals NHS Trust
Outcome results
None listed