Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma
Status:
Completed
Trial end date:
2019-11-19
Target enrollment:
Participant gender:
Summary
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.