Status:
TERMINATED
Prophylaxis With Apixaban in Transplant Eligible Patients With Multiple Myeloma Receiving Induction Therapy With IMiDs
Lead Sponsor:
Instituto de Investigacion Sanitaria La Fe
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Interventional, no-randomized, open-label, and single arm multicentre study of apixaban for the prevention of thromboembolic events during induction therapy in transplant-eligible patients with newly ...
Detailed Description
This study is designed to test the efficacy and safety of the oral anti factor Xa apixaban 2.5 mg given twice daily as a prophylaxis of VTE in transplant-eligible patients with multiple myeloma during...
Eligibility Criteria
Inclusion
- Signed written informed consent
- 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.
- Ages eligible for study: 18 to 70 years.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
Exclusion
- 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.
- 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.
- Low platelet count (\<50 x109/L).
- ALT \>3x UNL, bilirubin \>2x ULN.
- Creatinine clearance \<30 mL/min.
- 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.
- 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).
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04106700
Start Date
April 12 2019
End Date
October 5 2020
Last Update
February 15 2021
Active Locations (4)
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1
Hospital Clinico Universitario
Valencia, Spain, 46010
2
Hospital Universitario Doctor Peset
Valencia, Spain, 46017
3
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
4
Hospital General Universitario
Valencia, Spain