Trial Outcomes & Findings for Alteration in Timing of Plerixafor Administration (NCT NCT01149863)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Within the first 5 days following plerixafor initiation

Results posted on

2013-12-13

Participant milestones
Measure	Plerixafor 17 Hours Prior to Apheresis Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Overall Study STARTED	34
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Plerixafor 17 Hours Prior to Apheresis Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Overall Study Missing data or Not receiveing studydrug	3

Alteration in Timing of Plerixafor Administration

Baseline characteristics by cohort
Measure	Plerixafor 17 Hours Prior to Apheresis n=34 Participants Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Age, Customized	59 Years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

Timeframe: Within the first 5 days following plerixafor initiation

Outcome measures
Measure	Plerixafor 17 Hours Prior to Apheresis n=31 Participants Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.	31 Participants

Timeframe: Within the first 5 days following plerixafor initiation

Outcome measures
Measure	Plerixafor 17 Hours Prior to Apheresis n=31 Participants Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs	22 Participants

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events
Measure	Plerixafor 17 Hours Prior to Apheresis n=31 participants at risk Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Blood and lymphatic system disorders Hypokalemia	3.2% 1/31
Musculoskeletal and connective tissue disorders Bone Pain	3.2% 1/31

Other adverse events
Measure	Plerixafor 17 Hours Prior to Apheresis n=31 participants at risk Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Musculoskeletal and connective tissue disorders Bone Pain	51.6% 16/31
General disorders Nausea	35.5% 11/31
Surgical and medical procedures Injection site reactions	32.3% 10/31
Blood and lymphatic system disorders hypokalemia	22.6% 7/31
Gastrointestinal disorders Diarrhea	16.1% 5/31
General disorders Dizziness	12.9% 4/31

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