Trial Outcomes & Findings for Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients (NCT NCT00103610)

Last Updated: 2014-03-13

Results Overview

Proportion of participants achieving a target of ≥ 5\*10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

298 participants

Primary outcome timeframe

Days 5 to 8

Results posted on

2014-03-13

Participant Flow

Participants with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplant were recruited from 31 centers in the U.S. and 1 in Canada. The first participant was randomized on 18 January 2005 and the last participant's last study visit occurred on 20 December 2007. A total of 298 participants were randomized.

Participant milestones

Participant milestones
Measure	G-CSF Plus Plerixafor Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Overall Study STARTED	150	148
Overall Study COMPLETED	112	68
Overall Study NOT COMPLETED	38	80

Reasons for withdrawal

Reasons for withdrawal
Measure	G-CSF Plus Plerixafor Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Overall Study Entered Rescue Procedure	10	52
Overall Study Death	16	12
Overall Study Elective Withdrawal	4	0
Overall Study Lost to Follow-up	3	1
Overall Study Adverse Event	2	2
Overall Study Other	2	7
Overall Study Failed mobilization	1	5
Overall Study Noncompliance	0	1

Baseline Characteristics

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-CSF Plus Plerixafor n=150 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=148 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	Total n=298 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	57.5 years STANDARD_DEVIATION 10.3 • n=7 Participants	56.3 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	102 Participants n=7 Participants	202 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	136 participants n=5 Participants	140 participants n=7 Participants	276 participants n=5 Participants
Race/Ethnicity, Customized African-American	6 participants n=5 Participants	1 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 5 to 8

Population: Intent-to-Treat Population

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=150 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=148 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis Proportion achieving target in ≤4 days	0.593 proportion of participants	0.196 proportion of participants
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis Proportion not achieving target in ≤4 days	0.407 proportion of participants	0.804 proportion of participants

SECONDARY outcome

Timeframe: up to Day 38

Population: Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.

Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=150 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=145 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Number of Participants With Adverse Events AEs Leading to early study termination	2 participants	4 participants
Number of Participants With Adverse Events Grade 3 (severe) or 4 (life-threatening) AEs	11 participants	14 participants
Number of Participants With Adverse Events SAEs	8 participants	10 participants
Number of Participants With Adverse Events Adverse Events (AEs)	146 participants	138 participants
Number of Participants With Adverse Events Related AEs	98 participants	60 participants
Number of Participants With Adverse Events AEs Leading to early treatment termination	3 participants	3 participants

SECONDARY outcome

Timeframe: up to Day 8

Population: Intent-to-treat Population

Proportion of participants achieving a target of \>=2\*10\^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=150 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=148 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis Proportion achieving target in ≤4 days	0.867 proportion of participants	0.473 proportion of participants
Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis Proportion not achieving target in ≤4 days	0.133 proportion of participants	0.527 proportion of participants

SECONDARY outcome

Timeframe: up to Day 8

Population: Intent-to-Treat Population.

The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5\*10\^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=147 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=142 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg	3.0 Days Interval 1.0 to Not enough participants reached the threshold to support estimating the upper range.	NA Days Not enough participants reached the threshold to estimate the values.

SECONDARY outcome

Timeframe: Up to Month 13

Population: Participants who received a stem cell transplant.

The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1.0\*10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=135 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=82 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment	10.0 Days Interval 10.0 to 11.0	10.0 Days Interval 10.0 to 11.0

SECONDARY outcome

Timeframe: Up to Month 13

Population: Participants who received a stem cell transplant

The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20\*10\^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=135 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=82 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Median Number of Days to Platelet (PLT) Engraftment	20.0 Days Interval 17.0 to 25.0	20.0 Days Interval 18.0 to 25.0

SECONDARY outcome

Timeframe: approximately Day 138

Population: Participants who received a stem cell transplant and were evaluable at 100 days post-transplant

The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=135 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=82 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Graft Durability at 100 Days Post Transplantation Proportion of participants with durable graft	0.948 proportion of participants	0.951 proportion of participants
Graft Durability at 100 Days Post Transplantation Proportion of participants without durable graft	0.052 proportion of participants	0.049 proportion of participants

SECONDARY outcome

Timeframe: approximately Month 7

Population: Participants who received a stem cell transplant and were evaluable at 6 months post-transplant

The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=123 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=78 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Graft Durability at 6 Months Post Transplantation Proportion of participants with a durable graft	0.976 proportion of participants	0.987 proportion of participants
Graft Durability at 6 Months Post Transplantation Proportion of participants without a durable graft	0.024 proportion of participants	0.013 proportion of participants

SECONDARY outcome

Timeframe: approximately Month 13

Population: Participants who received a stem cell transplant and were evaluable at 12 months post-transplant

The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=112 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=65 Participants Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Graft Durability at 12 Months Post Transplantation Proportion of participants without a durable graft	0.018 proportion of participants	0.0 proportion of participants
Graft Durability at 12 Months Post Transplantation Proportion of participants with a durable graft	0.982 proportion of participants	1.0 proportion of participants

Adverse Events

G-CSF Plus Plerixafor

Serious events: 8 serious events

Other events: 145 other events

Deaths: 0 deaths

G-CSF Plus Placebo

Serious events: 10 serious events

Other events: 136 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Genzyme MedInfo

Genzyme Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Publication restrictions are in place

Restriction type: OTHER

Measure	G-CSF Plus Plerixafor n=150 participants at risk Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=145 participants at risk Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Blood and lymphatic system disorders Febrile neutropenia	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Blood and lymphatic system disorders Thrombocytopenia	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Cardiac disorders Atrial fibrillation	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	1.4% 2/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Non-cardiac chest pain	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Pyrexia	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Infections and infestations Bacteraemia	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Infections and infestations Bacterial sepsis	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Infections and infestations Catheter bacteraemia	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Infections and infestations Pseudomonal sepsis	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Infections and infestations Sinusitis	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Back pain	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Convulsion	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Dizziness	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Renal and urinary disorders Renal failure acute	0.00% 0/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.69% 1/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Vascular disorders Hypotension	0.67% 1/150 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	0.00% 0/145 • Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38). Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.