Trial Outcomes & Findings for A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma (NCT NCT02749617)

NCT ID: NCT02749617

Last Updated: 2021-08-23

Results Overview

serial anti Xa activity

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-08-23

Participant Flow

Participant milestones

Measure	Apixaban apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Baseline characteristics by cohort

Measure	Apixaban n=2 Participants apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	1 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 Canada	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Lack of data.

serial anti Xa activity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Due to lack of enrollment, plasma apixaban levels were not analyzed

Outcome measures

Outcome data not reported

Adverse Events

Apixaban

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Apixaban n=2 participants at risk apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
Blood and lymphatic system disorders Nose Bleed	50.0% 1/2 • Number of events 3 • 6 months
General disorders Nausea	50.0% 1/2 • Number of events 1 • 6 months
General disorders Flu-like Symptoms	50.0% 1/2 • Number of events 1 • 6 months
General disorders Diarrhea	50.0% 1/2 • Number of events 1 • 6 months
General disorders Pseudomonas aerugionosa	50.0% 1/2 • Number of events 1 • 6 months
General disorders Skin Itchiness	50.0% 1/2 • Number of events 3 • 6 months
General disorders Low Energy	50.0% 1/2 • Number of events 1 • 6 months
General disorders Back right-sided buttock pain	50.0% 1/2 • Number of events 1 • 6 months

Additional Information

Director of HRP

Hematology Research Program (HRP)

Phone: 6048754111

Email: alee14@bccancer.bc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place