Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma

Completed · Phase 4

Conditions studied: Venous Thromboembolism, Multiple Myeloma

In brief

Patients living with multiple myeloma (MM) have an increased risk of venous thromboembolism (VTE) due to the disease itself and the use of targeted therapies, including immunomodulatory drugs (IMiDs). Prevention of VTE has become a major management challenge during MM treatment. There is a paucity of data with respect to the non-vitamin K oral anticoagulants (NOACs) in the cancer population. However, the NOACs offer comparable efficacy but improved safety compared with warfarin. Apixaban has shown excellent safety and efficacy for treatment and prevention of recurrent VTE (1,2). The safety and efficacy of apixaban for primary prevention of VTE in MM patients has not been established. Aim #1: To quantify the 6-month rate of major and clinically relevant non-major bleeding in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE. Hypothesis #1: The 6-month rate of major and clinically relevant non-major bleeding in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be ≤3% (2). Although the MM population, in general, has a higher medical acuity than that of the previous large randomized controlled trials of apixaban, we will be selecting a stable population of MM patients who are appropriate for immunomodulatory therapy. Aim #2: To quantify 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE. Hypothesis #2: The 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be \<7% (3). Although additional therapies for MM such as dexamethasone and erythropoietin-stimulating agents may further increase the risk of VTE, the rate of incident VTE should be reduced to \<7% with apixaban.

Key facts

Study ID: NCT02958969
Run by: Gregory Piazza
People needed: 50
Starts: 2018-02-28
Expected to finish: 2019-11-19
Last updated by the study team: 2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women
Age > 18 years
Current or prior diagnosis of symptomatic MM based on International Myeloma Working Group (IMWG) guidelines (http://imwg.myeloma.org/category/guidelines-2/) and will be starting or already receiving IMiD therapy with thalidomide [Thalomid], lenalinomide [Revlimid], or pomalidomide [Pomalyst]
IMiD therapy given in the setting of newly diagnosed MM, relapsed MM, progressive MM, maintenance therapy or consolidation therapy as per IMWG criteria
Willing to provide written informed consent
Eastern Cooperative Oncology Group (ECOG) functional status ≤ 2
Providers must plan to treat the patient with IMiD therapy for a minimum of 6 cycles

You may not qualify if…

Pregnancy
Breastfeeding
Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (such as oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, condoms, spermicides]) to avoid pregnancy for the entire study
Any prior venous thromboembolism
Contraindication to anticoagulant therapy
Conditions for which serious bleeding may occur including:
Current or within last 6 months: intracranial bleeding, intraocular bleeding, gastrointestinal bleeding, endoscopically documented ulcer disease
Current or within last month: head trauma or other major trauma, major surgery
Current or within last 2 weeks: stroke, neurosurgical procedure
Current: gross hematuria, major unhealed wound, major surgery planned during the trial period, intracranial mass, vascular malformation, or aneurysm, overt bleeding, blood dyscrasia
CNS involvement of MM or other history of CNS malignancy
Active and clinically significant liver disease
Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
Current endocarditis
Requirement for ongoing anticoagulant therapy, including mechanical heart valve replacement and atrial fibrillation
Severe valvular heart disease, including rheumatic heart disease and mitral stenosis
Bioprosthetic heart valve replacement
Requirement for dual antiplatelet therapy or single agent antiplatelet therapy with clopidogrel, prasugrel, or ticagrelor
Requirement for aspirin at a dose higher than 165 mg daily.
Hemoglobin < 9 mg/dL at time of screening
Platelet count < 100,000/mm3 at time of screening
Serum calculated creatinine clearance (CrCl) < 25 ml/m at time of screening
Alanine aminotransferase or aspartate aminotransferase level > 2 times the upper limit of the normal at time of screening
Total bilirubin level > 1.5 times the upper limit of the normal at time of screening
Life expectancy < 12 months or hospice care

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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