Thromboprophylaxis in Multiple Myeloma (TiMM)

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 18.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 18.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865

• Registration Number: EUCTR2015-002668-18-GB
• Lead Sponsor: King’s College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-11
• Study Completion: 2017-06-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

(1) Patients >18 years of age, newly diagnosed with multiple myeloma at King’s College Hospital NHS Foundation Trust.
(2) Able to give written consent to participate.

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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

(1) Pregnant and breast-feeding women, based on a verbal history from the patient.
(2) Hypersensitivity to the active substances or to any of the excipients being used in this study.
(3) Patients unable to be prescribed aspirin or enoxaparin as standard care.
(4) Patients already prescribed anticoagulant or anti-platelet therapy for other indications.
(5) Hypersensitivity to the active substance or to any of the excipients of apixaban; i.e. active clinically significant bleeding; hepatic disease associated with coagulopathy and clinically relevant bleeding risk; lesion or condition if considered a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasm at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular neoplasms or major intraspinal or interacerebral vascular abnormalities; concomitant treatment with any other anticoagulant agent.
(6) Patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir).
(7) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Study & Design

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