Venous Thromboembolism Prophylaxis with Apixaban in Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma Receiving Induction Therapy with an Immunomodulatory-Based Regime

Phase 1

Active, not recruiting

• Conditions: Venous Thromboembolism (VTE) prophylaxis; MedDRA version: 20.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-004592-31-ES
• Lead Sponsor: Health Research Institute Hospital La Fe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-04
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Signed written informed consent:
•Each subject, or their legally acceptable representative, must sign an informed consent form indicating that he or she understands the purpose and procedures required for the study, and are willing to participate in the study. Consent to participate in the study will be obtained prior to screening.
Target population:
•Subjects must have documented newly diagnosed symptomatic multiple myeloma requiring front-line treatment.
•Patients should be considered transplant-eligible.
•Subjects will receive front-line induction therapy with a triplet regimen consisting of bortezomib, thalidomide and dexamethasone (VTD).
•To enter to the study at the same time of start anti myeloma induction therapy.
Patient features:
•Ages eligible for study: 18 to 70 years.
•Genders eligible for study: both.
•Race eligible for study: any.
•Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score =2.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Target population exceptions:
•Patients with the diagnosis of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or amyloidosis of light chain.
•Patients with smouldering multiple myeloma or monoclonal gammopathy of undeterminated significance.
•Patients considered non-transplant-eligible.
Medical history and concurrent diseases:
•Grade =2 of peripheral neuropathy.
•Prior history of documented any venous thromboembolism and arterial thrombosis event.
•Active or high risk of bleeding.
•Need for on-going anticoagulant or antiplatelet treatment.
•Contraindication of anticoagulant prophylaxis.
•Uncontrolled hypertension: systolic blood pressure >200 mmHg and/or diastolic blood pressure >100 mmHg.
•HIV, HBV or HCV-positive active.
•Expected survival <6 months.
•Weight <40 Kg.
•Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin, or other oral anticoagulants.
Laboratory test findings:
•Low platelet count (<50 x109/L).
•ALT >3x UNL, bilirubin >2x ULN.
•Creatinine clearance <30 mL/min.
Sex and reproductive status:
•Women of childbearing potential who are unwilling to use an acceptable method of contraception.
•Women of childbearing potential who are pregnant or breastfeeding.
•Women with a positive pregnancy test on enrollment, prior to investigational product administration.
Other exclusion criteria:
•Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study.
•Subjects unwilling or unable to comply with study medication instructions or study procedures (e.g. bilateral lower extremity venous ultrasonography).
•Known allergies to ingredients contained in apixaban.
• Use of any contraindicated medications with apixaban (see section 5.4.1).

Study & Design

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