Trial Outcomes & Findings for Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma (NCT NCT02958969)

NCT ID: NCT02958969

Last Updated: 2019-12-17

Results Overview

Symptomatic deep vein thrombosis or pulmonary embolism

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2019-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Apixaban apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apixaban n=50 Participants apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Symptomatic deep vein thrombosis or pulmonary embolism

Outcome measures

Outcome measures
Measure	Apixaban n=50 Participants apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Frequency of Symptomatic Venous Thromboembolism	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Apixaban n=50 Participants apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Frequency of Major and Clinically Relevant Non-major Bleeding	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Apixaban n=50 Participants apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Frequency of All-cause Mortality	0 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Apixaban n=50 Participants apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Frequency of Atherothrombotic Events	0 Participants

Adverse Events

Apixaban

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Apixaban n=50 participants at risk apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
Blood and lymphatic system disorders non-major bleeding	6.0% 3/50 • Number of events 3 • 1 year

Additional Information

Gregory Piazza

BWH

Phone: 6177326984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place