Multiple Myeloma Clinical Trial
Official title:
Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy
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.
MM is associated with an increased risk of venous thromboembolism (VTE). The use of targeted
therapies, including immunomodulatory drugs (IMiDs), has improved outcomes for patients with
MM but also increases the risk of VTE. Prevention of VTE has become a major management
dilemma during MM treatment. There is a paucity of data with respect to the non-vitamin K
oral anticoagulants (NOACs) in the cancer population, including patients with MM. However,
the NOACs have been shown to 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). Compared with injectable thromboprophylactic regimens such as
enoxaparin, apixaban offers the advantages of being orally administered and less reliant on
renal clearance. The safety and efficacy of apixaban for primary prevention of VTE in MM
patients has not been established. The current study will evaluate apixaban (2.5 mg twice
daily) in a patient population without a history of prior VTE. Although the current study
population is high risk for VTE, it is likely to be lower risk for VTE than those of the
prior randomized controlled trials of apixaban for secondary prevention. Furthermore, current
practice is to provide MM patients receiving IMiDs with prophylactic doses (not treatment
doses) of low-molecular weight heparin (such as enoxaparin 40 mg injected daily).
Accordingly, the rationale to test apixaban (2.5 mg twice daily) is consistent with the
standard practice of prophylactic anticoagulation.
The current study will provide event rates that will inform the design of a larger randomized
controlled trial. If safe and effective, apixaban will satisfy a critical unmet need and will
represent a substantial advance and "game changer" in the prevention of VTE in this high risk
patient population.
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