Trial Outcomes & Findings for Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients (NCT NCT00103662)

Last Updated: 2014-03-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

302 participants

Primary outcome timeframe

up to Day 6

Results posted on

2014-03-13

Participant Flow

Participants with multiple myeloma (MM) eligible for autologous hematopoietic stem cell transplant were recruited from 40 centers (38 in the U.S., 1 in Germany, 1 in Canada). The first participant was randomized on 04 February 2005 and the last participant's last study visit occurred on 22 January 2008. A total of 302 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 ≥ 6\*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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Overall Study STARTED	148	154
Overall Study COMPLETED	129	121
Overall Study NOT COMPLETED	19	33

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 ≥ 6\*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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Overall Study Entered Rescue Procedure	0	7
Overall Study Death	7	7
Overall Study Elective Withdrawal	5	5
Overall Study Lost to Follow-up	0	1
Overall Study Other	6	9
Overall Study Failed mobilization	0	4
Overall Study Intercurrent illness	1	0

Baseline Characteristics

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-CSF Plus Plerixafor n=148 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=154 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	Total n=302 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 8.4 • n=5 Participants	58.4 years STANDARD_DEVIATION 8.6 • n=7 Participants	58.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	107 Participants n=7 Participants	207 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	117 participants n=5 Participants	128 participants n=7 Participants	245 participants n=5 Participants
Race/Ethnicity, Customized African-American	18 participants n=5 Participants	14 participants n=7 Participants	32 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	11 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: up to Day 6

Population: Intent-to-Treat Population

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=148 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=154 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis. Proportion achieving target in ≤2 days	0.716 proportion of participants	0.344 proportion of participants
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis. Proportion not achieving target in ≤2 days	0.284 proportion of participants	0.656 proportion of participants

SECONDARY outcome

Timeframe: up to Day 38

Population: Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four 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=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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=151 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Number of Participants With Adverse Events AEs Leading to early termination	3 participants	0 participants
Number of Participants With Adverse Events Grade 3 (severe) or 4 (life-threatening) AEs	11 participants	11 participants
Number of Participants With Adverse Events Adverse Events (AEs)	140 participants	140 participants
Number of Participants With Adverse Events Related AEs	95 participants	67 participants
Number of Participants With Adverse Events AEs Leading to early treatment termination	1 participants	2 participants
Number of Participants With Adverse Events Serious Adverse Events (SAEs)	4 participants	6 participants

SECONDARY outcome

Timeframe: up to Day 8

Population: Intent-to-Treat Population

Proportion of participants achieving a target of ≥ 6\*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=148 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=154 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis. Proportion not achieving target in ≤4 days	0.243 proportion of participants	0.487 proportion of participants
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis. Proportion achieving target in ≤4 days	0.757 proportion of participants	0.513 proportion of 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=148 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=154 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis. Proportion achieving target in ≤4 days	0.953 proportion of participants	0.883 proportion of participants
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis. Proportion not achieving target in ≤4 days	0.047 proportion of participants	0.117 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 have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6\*10\^6 CD34+ cells/kg) for transplantation.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=144 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=150 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Median Number of Days to ≥6*10^6 CD34+ Cells/kg	1.0 Days Interval 1.0 to 2.0	4.0 Days Interval 2.0 to Not enough participants reached the threshold to support estimating the upper range.

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 and was evaluated up to 12 months post transplant.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=142 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=136 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment	11.0 Days Interval 10.0 to 12.0	11.0 Days Interval 11.0 to 12.0

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 and was evaluated up to 12 months post transplant.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=142 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=136 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Median Number of Days to Platelet (PLT) Engraftment	18.0 Days Interval 16.0 to 22.0	18.0 Days Interval 16.0 to 21.0

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=142 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=136 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Graft Durability at 100 Days Post Transplantation Proportion of participants without a durable graft	0.014 proportion of participants	0.022 proportion of participants
Graft Durability at 100 Days Post Transplantation Proportion of participants with a durable graft	0.986 proportion of participants	0.978 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=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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=127 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Graft Durability at 6 Months Post Transplantation Proportion of participants with a durable graft	0.985 proportion of participants	0.984 proportion of participants
Graft Durability at 6 Months Post Transplantation Proportion of participants without a durable graft	0.015 proportion of participants	0.016 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 at 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=128 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=120 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Graft Durability at 12 Months Post Transplantation Proportion of participants with a durable graft	0.992 proportion of participants	0.992 proportion of participants
Graft Durability at 12 Months Post Transplantation Proportion of participants without a durable graft	0.008 proportion of participants	0.008 proportion of participants

Adverse Events

G-CSF Plus Plerixafor

Serious events: 4 serious events

Other events: 140 other events

Deaths: 0 deaths

G-CSF Plus Placebo

Serious events: 6 serious events

Other events: 140 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	G-CSF Plus Plerixafor n=147 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.	G-CSF Plus Placebo n=151 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 ≥ 6\*10\^6 CD34+ cells/kg were collected.
Cardiac disorders Atrial fibrillation	0.68% 1/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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% 0/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Nausea	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	1.3% 2/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Vomiting	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Enterobacter bacteraemia	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.
Metabolism and nutrition disorders Dehydration	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Bone pain	0.68% 1/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Hemiparesis	0.68% 1/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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% 0/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Muscle spasticity	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.
Psychiatric disorders Agitation	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Deep vein thrombosis	0.68% 1/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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% 0/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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 Jugular vein thrombosis	0.00% 0/147 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.	0.66% 1/151 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). Four 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.

Other adverse events

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