NCT02958969

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

Completed Phase 4 Results posted Last updated 17 December 2019

What this trial tests

Phase 4 trial testing Apixaban in Venous Thromboembolism in 50 participants. Completed in 19 November 2019.

Timeline

28 February 2018

Primary endpoint
30 June 2019

19 November 2019

Quick facts

Lead sponsor	Gregory Piazza
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	28 February 2018
Primary completion	30 June 2019
Estimated completion	19 November 2019
Sites	2 locations across United States

Drugs / interventions tested

• Apixaban (apixaban) — full drug profile →

Conditions studied

• Venous Thromboembolism — all drugs for Venous Thromboembolism →
• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Gregory Piazza

Who can join

18 and older, any sex, with Venous Thromboembolism or Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Symptomatic Venous Thromboembolism Primary · 6 months

Symptomatic deep vein thrombosis or pulmonary embolism

Group	Value	95% CI
Apixaban	0

Frequency of Major and Clinically Relevant Non-major Bleeding Primary · 6 months

Major and clinically relevant non-major bleeding. Using the ISTH classification, bleeding is defined as major if it is overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, requires the transfusion of 2 or more units of blood, occurs into a critical site, or contributes to death (12). Using the ISTH classification, clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.

Group	Value	95% CI
Apixaban	3

Frequency of All-cause Mortality Secondary · 6 months

All-cause mortality at 6 months will be recorded. Cause of death will be classified as related to cancer, myocardial infarction, PE, other cardiovascular or other disease state. Death will be attributed to PE if there is evidence to support an association with PE.

Group	Value	95% CI
Apixaban	0

Frequency of Atherothrombotic Events Secondary · 6 months

6-month rates of myocardial infarction and stroke will be calculated.

Group	Value	95% CI
Apixaban	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Apixaban

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	Apixaban
non-major bleeding	Blood and lymphatic system disorders	—

Data from ClinicalTrials.gov NCT02958969 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multiple Myeloma and Thrombosis: Prophylaxis and Risk Prediction Tools.
   Fotiou D, Gavriatopoulou M, Terpos E. · · 2020 · cited 48× · PMID 31940972 · DOI 10.3390/cancers12010191
2. Evidence Gaps in the Era of Non-Vitamin K Oral Anticoagulants.
   Aronis KN, Hylek EM. · · 2018 · cited 27× · PMID 29374049 · DOI 10.1161/jaha.117.007338
3. Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy.
   Cornell RF, Goldhaber SZ, Engelhardt BG, Moslehi J, et al · · 2019 · cited 22× · PMID 30873378 · DOI 10.3389/fonc.2019.00045
4. Primary Thromboprophylaxis in Patients with Malignancies: Daily Practice Recommendations by the Hemostasis Working Party of the German Society of Hematology and Medical Oncology (DGHO), the Society of Thrombosis and Hemostasis Research (GTH), and the Austrian Society of Hematolog
   Kirschner M, do Ó Hartmann N, Parmentier S, Hart C, et al · · 2021 · cited 11× · PMID 34200741 · DOI 10.3390/cancers13122905
5. What's new in the prevention and treatment of cancer-associated thrombosis?
   Kimpton M, Carrier M. · · 2019 · cited 2× · PMID 31808858 · DOI 10.1182/hematology.2019000023
6. Study on Risk Factors and Treatment Strategies for Deep Vein Thrombosis in Patients with Multiple Myeloma.
   Guo Y, Yan L, Yang X, Fan C, et al · · 2025 · cited 1× · PMID 40837328 · DOI 10.2147/cmar.s533589