Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02098109
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Lymphoma, Non-Hodgkin	Drug: XM02 Filgrastim; Drug: Filgrastim; Procedure: Apheresis; Drug: Plerixafor; Procedure: Stem Cell Transplant	Phase 2

Detailed Description

This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor. The FDA has determined that Granix is biosimilar to Neupogen, which means that they are similar in terms of quality, safety, and efficacy; however, Granix has not been tested in the context of stem cell mobilization to see how its effectiveness compares to that of Neupogen

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) When Administered in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
• Actual Study Start Date: Aug 20, 2014
• Actual Primary Completion Date: Jun 10, 2016
• Actual Study Completion Date: Sep 18, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XM02 Filgrastim (Granix) and Plerixafor XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize > 2.0 x 10^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.	Drug: XM02 Filgrastim; Other Names: Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix ; Procedure: Apheresis; Drug: Plerixafor; Other Names: Mozobil, AMD3100 ; Procedure: Stem Cell Transplant; Other Names: ASCT
Active Comparator: Filgrastim (Neupogen) and Plerixafor Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize > 2.0 x 10^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.	Drug: Filgrastim; Other Names: Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF ; Procedure: Apheresis; Drug: Plerixafor; Other Names: Mozobil, AMD3100 ; Procedure: Stem Cell Transplant; Other Names: ASCT

Outcome Measures

Primary Outcome Measures

1. Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms [Day 5]

Secondary Outcome Measures

1. Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms [Up to 20 days after last apheresis (Day 25-Day 28)]

   -Adverse events will be assessed using CTCAE version 4.0

2. Comparison of the Time to Neutrophil Engraftment Between the Two Arms [Up to Day 30 post-infusion]

   Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.

3. Comparison of the Time to Platelet Engraftment Between the Two Arms [Up to Day 100]

   Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.

4. Comparison of the Readmission Rate Between the Two Arms [Up to Day 100]

   Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse

5. Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms [Up to Day 8 (total collection)]

6. Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms [Up to Day 8 (total collection)]

7. Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms [Day 5]

8. Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms [Day 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age

• Diagnosis of multiple myeloma or non-Hodgkin lymphoma

• Eligible for autologous transplantation

• Adequate bone marrow function as defined as:

• White Blood Cell Count ≥ 3.0x109/L

• Absolute Neutrophil Count ≥ 1.5x109/L

• Platelet Count ≥ 100x109/L

• Able to understand and willing to sign an IRB-approved informed consent document

• Surgically or biologically sterile or willing to practice acceptable birth control, as follows:

• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day 1 of study treatment. Women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence

• Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence

Exclusion Criteria:

• Previous autologous stem cell collection

• Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products

• Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Camille Abboud, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02098109
• Other Study ID Numbers: 201403068
• First Posted: Mar 27, 2014
• Last Update Posted: Jul 18, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Plerixafor; Lenograstim

Study Results

Participant Flow

Recruitment Details	The study opened to participant enrollment on 08/20/2014 and closed to participant enrollment on 06/14/2016.

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Period Title: Overall Study
STARTED	49	51
COMPLETED	46	51
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor	Total
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Total of all reporting groups
Overall Participants	46	51	97
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (8.3)	58.5 (9.0)	60.6 (8.9)
Sex: Female, Male (Count of Participants)
Female	16 34.8%	21 41.2%	37 38.1%
Male	30 65.2%	30 58.8%	60 61.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 15.2%	3 5.9%	10 10.3%
White	38 82.6%	47 92.2%	85 87.6%
More than one race	1 2.2%	0 0%	1 1%
Unknown or Not Reported	0 0%	1 2%	1 1%
Region of Enrollment (participants) [Number]
United States	46 100%	51 100%	97 100%
Prior Therapies (number of prior therapies) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of prior therapies]	1.5 (0.8)	1.4 (0.8)	1.5 (0.8)
Diagnosis (Count of Participants)
Multiple myeloma	43 93.5%	43 84.3%	86 88.7%
Non-Hodgkin's Lymphoma	3 6.5%	8 15.7%	11 11.3%
Prior Radiation (Count of Participants)
Count of Participants [Participants]	10 21.7%	13 25.5%	23 23.7%

Outcome Measures

1. Primary Outcome

Title	Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	46	51
Mean (Standard Deviation) [cells/kg]	11.6 (6.7)	10.0 (6.8)

2. Secondary Outcome

Title	Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Description	-Adverse events will be assessed using CTCAE version 4.0
Time Frame	Up to 20 days after last apheresis (Day 25-Day 28)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	46	51
Bone pain	19 41.3%	22 43.1%
Thrombocytopenia	18 39.1%	20 39.2%
Anemia	13 28.3%	18 35.3%
Alkaline phosphatase increased	10 21.7%	12 23.5%
Nausea and/or vomiting	10 21.7%	10 19.6%
Leukocytosis	8 17.4%	10 19.6%

3. Secondary Outcome

Title	Comparison of the Time to Neutrophil Engraftment Between the Two Arms
Description	Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.
Time Frame	Up to Day 30 post-infusion

Outcome Measure Data

Analysis Population Description

(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	44	50
Median (95% Confidence Interval) [days]	11	11.5

4. Secondary Outcome

Title	Comparison of the Time to Platelet Engraftment Between the Two Arms
Description	Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.
Time Frame	Up to Day 100

Outcome Measure Data

Analysis Population Description

(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	44	50
Median (95% Confidence Interval) [days]	18	17.5

5. Secondary Outcome

Title	Comparison of the Readmission Rate Between the Two Arms
Description	Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse
Time Frame	Up to Day 100

Outcome Measure Data

Analysis Population Description

(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	44	50
Count of Participants [Participants]	11 23.9%	9 17.6%

6. Secondary Outcome

Title	Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Time Frame	Up to Day 8 (total collection)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	46	51
Number [percentage of participants]	100 217.4%	100 196.1%

7. Secondary Outcome

Title	Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Time Frame	Up to Day 8 (total collection)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	46	51
Number [percentage of participants]	96 208.7%	96 188.2%

8. Secondary Outcome

Title	Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	46	51
Number [percentage of participants]	98 213%	90 176.5%

9. Secondary Outcome

Title	Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor	Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)	Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
Measure Participants	46	51
Number [percentage of participants]	83 180.4%	76 149%

Adverse Events

Arm/Group Title	XM02 Filgrastim (Granix) and Plerixafor		Filgrastim (Neupogen) and Plerixafor
Arm/Group Description	XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)		Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
All Cause Mortality
	XM02 Filgrastim (Granix) and Plerixafor		Filgrastim (Neupogen) and Plerixafor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	XM02 Filgrastim (Granix) and Plerixafor		Filgrastim (Neupogen) and Plerixafor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/46 (4.3%)		3/51 (5.9%)
Cardiac disorders
Atrial fibrillation	1/46 (2.2%)		0/51 (0%)
General disorders
Edema - limbs	0/46 (0%)		1/51 (2%)
Pain	0/46 (0%)		1/51 (2%)
Infections and infestations
Central line site cellulitis	0/46 (0%)		1/51 (2%)
Psychiatric disorders
Panic attack	1/46 (2.2%)		0/51 (0%)
Renal and urinary disorders
Acute kidney injury	1/46 (2.2%)		0/51 (0%)
Vascular disorders
Hypotension	0/46 (0%)		1/51 (2%)
Other (Not Including Serious) Adverse Events
	XM02 Filgrastim (Granix) and Plerixafor		Filgrastim (Neupogen) and Plerixafor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/46 (97.8%)		50/51 (98%)
Blood and lymphatic system disorders
Anemia	13/46 (28.3%)		18/51 (35.3%)
Febrile neutropenia	0/46 (0%)		1/51 (2%)
Leukocytosis	8/46 (17.4%)		10/51 (19.6%)
Cardiac disorders
Palpitations	2/46 (4.3%)		0/51 (0%)
Eye disorders
Scleral disorder	0/46 (0%)		1/51 (2%)
Gastrointestinal disorders
Abdominal pain	1/46 (2.2%)		3/51 (5.9%)
Bloating	1/46 (2.2%)		0/51 (0%)
Constipation	4/46 (8.7%)		3/51 (5.9%)
Diarrhea	3/46 (6.5%)		6/51 (11.8%)
Dyspepsia	2/46 (4.3%)		0/51 (0%)
Dysphagia	1/46 (2.2%)		0/51 (0%)
Gastroesophageal reflux disease	1/46 (2.2%)		0/51 (0%)
Nausea	9/46 (19.6%)		8/51 (15.7%)
Oral dysesthesia	1/46 (2.2%)		1/51 (2%)
Vomiting	1/46 (2.2%)		4/51 (7.8%)
General disorders
Chills	1/46 (2.2%)		5/51 (9.8%)
Edema - limbs	1/46 (2.2%)		4/51 (7.8%)
Fatigue	0/46 (0%)		3/51 (5.9%)
Fever	0/46 (0%)		2/51 (3.9%)
Injection site reaction	0/46 (0%)		2/51 (3.9%)
Non-cardiac chest pain	2/46 (4.3%)		2/51 (3.9%)
Pain	1/46 (2.2%)		0/51 (0%)
Pain at biopsy site	1/46 (2.2%)		0/51 (0%)
Pain at catheter site	1/46 (2.2%)		0/51 (0%)
Infections and infestations
Cellulitis	0/46 (0%)		1/51 (2%)
Rhinovirus positive culture	0/46 (0%)		1/51 (2%)
Upper respiratory infection	1/46 (2.2%)		0/51 (0%)
Injury, poisoning and procedural complications
Bleeding at catheter site	5/46 (10.9%)		4/51 (7.8%)
Bruising	1/46 (2.2%)		0/51 (0%)
Discharge at catheter	1/46 (2.2%)		0/51 (0%)
Drainage at catheter	0/46 (0%)		1/51 (2%)
Erythema at catheter site	1/46 (2.2%)		0/51 (0%)
Fall	1/46 (2.2%)		0/51 (0%)
Pain at catheter site	1/46 (2.2%)		0/51 (0%)
Investigations
Activated partial thromboplastin time prolonged	8/46 (17.4%)		4/51 (7.8%)
Alanine aminotransferase increased	2/46 (4.3%)		1/51 (2%)
Alkaline phosphatase increased	10/46 (21.7%)		12/51 (23.5%)
Aspartate aminotransferase increased	2/46 (4.3%)		1/51 (2%)
Blood bilirubin increased	1/46 (2.2%)		1/51 (2%)
Creatinine increased	3/46 (6.5%)		1/51 (2%)
INR increased	7/46 (15.2%)		4/51 (7.8%)
Lymphocyte count decreased	18/46 (39.1%)		21/51 (41.2%)
Lymphocyte count increased	15/46 (32.6%)		10/51 (19.6%)
Neutrophil count decreased	3/46 (6.5%)		1/51 (2%)
Platelet count decreased	18/46 (39.1%)		20/51 (39.2%)
Weight loss	0/46 (0%)		1/51 (2%)
White blood cell decreased	5/46 (10.9%)		3/51 (5.9%)
Metabolism and nutrition disorders
Anorexia	0/46 (0%)		1/51 (2%)
Hypercalcemia	0/46 (0%)		2/51 (3.9%)
Hyperglycemia	0/46 (0%)		1/51 (2%)
Hyperkalemia	1/46 (2.2%)		0/51 (0%)
Hypernatremia	1/46 (2.2%)		0/51 (0%)
Hyperuricemia	4/46 (8.7%)		3/51 (5.9%)
Hypoalbuminemia	3/46 (6.5%)		4/51 (7.8%)
Hypocalcemia	1/46 (2.2%)		2/51 (3.9%)
Hypoglycemia	2/46 (4.3%)		0/51 (0%)
Hypokalemia	3/46 (6.5%)		2/51 (3.9%)
Hypomagnesemia	1/46 (2.2%)		1/51 (2%)
Hyponatremia	1/46 (2.2%)		1/51 (2%)
Hypophosphatemia	3/46 (6.5%)		2/51 (3.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/46 (15.2%)		6/51 (11.8%)
Back pain	2/46 (4.3%)		4/51 (7.8%)
Bone pain	19/46 (41.3%)		22/51 (43.1%)
Generalized muscle weakness	1/46 (2.2%)		0/51 (0%)
Hand cramping	0/46 (0%)		1/51 (2%)
Joint range of motion decreased	0/46 (0%)		1/51 (2%)
Neck pain	0/46 (0%)		1/51 (2%)
Pain in extremity	2/46 (4.3%)		2/51 (3.9%)
Nervous system disorders
Dizziness	3/46 (6.5%)		5/51 (9.8%)
Headache	3/46 (6.5%)		4/51 (7.8%)
Hypersomnia	1/46 (2.2%)		0/51 (0%)
Movements involuntary	1/46 (2.2%)		0/51 (0%)
Neuralgia	1/46 (2.2%)		0/51 (0%)
Numbness of face	0/46 (0%)		1/51 (2%)
Paresthesia	6/46 (13%)		4/51 (7.8%)
Peripheral sensory neuropathy	1/46 (2.2%)		2/51 (3.9%)
Tremor	1/46 (2.2%)		0/51 (0%)
Psychiatric disorders
Anxiety	7/46 (15.2%)		3/51 (5.9%)
Confusion	1/46 (2.2%)		1/51 (2%)
Depression	1/46 (2.2%)		0/51 (0%)
Renal and urinary disorders
Proteinuria	0/46 (0%)		1/51 (2%)
Urinary retention	1/46 (2.2%)		0/51 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	2/46 (4.3%)		0/51 (0%)
Dyspnea	5/46 (10.9%)		4/51 (7.8%)
Productive cough	0/46 (0%)		1/51 (2%)
Sore throat	1/46 (2.2%)		0/51 (0%)
Skin and subcutaneous tissue disorders
Fever blister	1/46 (2.2%)		0/51 (0%)
Hyperhidrosis	1/46 (2.2%)		0/51 (0%)
Hypohidrosis	0/46 (0%)		1/51 (2%)
Pruritus	1/46 (2.2%)		1/51 (2%)
Purpura	1/46 (2.2%)		0/51 (0%)
Rash maculo-papular	1/46 (2.2%)		1/51 (2%)
Skin ulceration	1/46 (2.2%)		0/51 (0%)
Vascular disorders
Hypertension	1/46 (2.2%)		2/51 (3.9%)
Hypotension	4/46 (8.7%)		2/51 (3.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.