Trial Outcomes & Findings for Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant (NCT NCT00998049)

Results Overview

Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

After 2 days of apheresis

Results posted on

2015-05-14

Participant Flow

Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.

One participant was deemed ineligible and is excluded from all analyses per study design.

Participant milestones

Participant milestones
Measure	Plerixafor Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Age, Continuous	60 years n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	25 Participants n=93 Participants
Region of Enrollment United States	39 participants n=93 Participants

PRIMARY outcome

Timeframe: After 2 days of apheresis

Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.

Outcome measures

Outcome measures
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis	38 participants

SECONDARY outcome

Timeframe: Day 1

Number of CD34 cells/kg collected on day 1.

Outcome measures

Outcome measures
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
CD34 Yield on Day 1	3870000 cells/kg Interval 670000.0 to 9160000.0

SECONDARY outcome

Timeframe: Day 2

Number of CD34 cells/kg collected on day 2

Outcome measures

Outcome measures
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
CD34 Yield Day 2	3550000 cells/kg Interval 470000.0 to 9170000.0

SECONDARY outcome

Timeframe: Duration of apheresis (up to 7 days)

Outcome measures

Outcome measures
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Median Number of Days of Apheresis	4 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Duration of apheresis (up to 7 days)

Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.

Outcome measures

Outcome measures
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Time to Reach 6 Million CD34 Cells	5 days Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: Duration of apheresis (up to 7 days)

The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.

Outcome measures

Outcome measures
Measure	Plerixafor n=39 Participants Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Rate of Failure to Mobilize	3 percentage of participants Interval 0.006 to 13.0

Adverse Events

Plerixafor

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Plerixafor n=39 participants at risk Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Blood and lymphatic system disorders Anemia	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Abdominal pain	17.9% 7/39 • Number of events 7
Gastrointestinal disorders Bloating	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Diarrhea	25.6% 10/39 • Number of events 10
Gastrointestinal disorders Nausea	43.6% 17/39 • Number of events 17
General disorders Injection site reaction	5.1% 2/39 • Number of events 2
Investigations Platelet count decreased	5.1% 2/39 • Number of events 2
Nervous system disorders Dizziness	20.5% 8/39 • Number of events 8
Nervous system disorders Headache	20.5% 8/39 • Number of events 8

Additional Information

Dr. Shaji Kumar

Mayo Clinic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place