Trial Outcomes & Findings for Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection (NCT NCT01095757)

NCT ID: NCT01095757

Last Updated: 2014-09-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: Within the first 4 days following the first dose of Plerixafor
• Results posted on: 2014-09-29

Participant Flow

Participant milestones

Measure	Plerixafor + Chemo and G-CSF Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF). Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

Baseline characteristics by cohort

Measure	Plerixafor + Chemo and G-CSF n=45 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Age, Continuous Multiple Myeloma (MM), n = 17	58 years n=5 Participants
Age, Continuous Lymphoma, n = 28	56 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	14 Participants n=5 Participants
Race (NIH/OMB) White	29 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	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 4 days following the first dose of Plerixafor

Outcome measures

Measure	Multiple Myeloma n=10 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.	Lymphoma n=23 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis	9 participants	17 participants

PRIMARY outcome

Timeframe: Within the first 4 days following the first dose of Plerixafor

Outcome measures

Measure	Multiple Myeloma n=10 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.	Lymphoma n=23 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg	10 participants	23 participants

SECONDARY outcome

Timeframe: Within the first 4 days following the first dose of Plerixafor

Outcome measures

Measure	Multiple Myeloma n=10 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.	Lymphoma n=23 Participants Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)	12.4 days Standard Deviation 1.62	12.105 days Standard Deviation 1.63

Adverse Events

Plerixafor + Chemo and G-CSF

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Plerixafor + Chemo and G-CSF n=45 participants at risk Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Gastrointestinal disorders Nausea	28.9% 13/45
Musculoskeletal and connective tissue disorders Bone Pain	26.7% 12/45
Gastrointestinal disorders Diarrhea	26.7% 12/45
General disorders Fatigue	24.4% 11/45
Blood and lymphatic system disorders Hypokalemia	17.8% 8/45
General disorders Lightheadedness	15.6% 7/45
General disorders Headache	13.3% 6/45
Blood and lymphatic system disorders Thrombocytopenia Grade 1/2	57.8% 26/45
Blood and lymphatic system disorders Thrombocytopenia Over Grade 2	37.8% 17/45
Blood and lymphatic system disorders Anemia	2.2% 1/45

Additional Information

Dr. Edmund Waller

Winship Cancer Institute Emory University

Phone: 404-727-4995

Email: ewaller@emory.edu

Results disclosure agreements

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