A study of the reaction of the vessels and cells of patients with myeloma getting chemotherapy.

Phase 1

• Conditions: 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 System Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1 Level: PT Classification code 10069909 Term: Metastatic pulmonary embolism System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: LLT Classification code 10000853 Term: Acute massive pulmonary embolism System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1 Level: LLT Classification code 10013877 Term: DVT System Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1 Level: LLT Classification code 10013879 Term: DVT of legs System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-001813-17-GB
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-04
• Study Completion: 2017-11-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 42

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified