Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

• Sponsor: Genzyme, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00322387
• Collaborator: (none)
• Enrollment: 40
• Locations: 5
• Arms: 4
• Duration (Months): 27
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin; Multiple Myeloma	Drug: G-CSF and plerixafor	Phase 2

Detailed Description

An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plerixafor PM Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications.	Drug: G-CSF and plerixafor; G-CSF and plerixafor were administered as described in the treatment arms.; Other Names: Mozobil AMD3100
Experimental: Plerixafor AM Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications.	Drug: G-CSF and plerixafor; G-CSF and plerixafor were administered as described in the treatment arms.; Other Names: Mozobil AMD3100
Experimental: Low CD34+ Count/ Plerixafor PM Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications.	Drug: G-CSF and plerixafor; G-CSF and plerixafor were administered as described in the treatment arms.; Other Names: Mozobil AMD3100
Experimental: Plerixafor After Chemo This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications.	Drug: G-CSF and plerixafor; G-CSF and plerixafor were administered as described in the treatment arms.; Other Names: Mozobil AMD3100

Outcome Measures

Primary Outcome Measures

1. Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant [13 months]

   Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.

Secondary Outcome Measures

1. Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL [Days 4-5 (first dose of plerixafor to apheresis)]

   The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).

2. Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant [2 months]

   Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria (Abbreviated List):

• MM in first partial response/complete response, first relapse, or second partial/complete response

• NHL in first or second partial or complete remission

• NHL patients who do not have bone marrow involvement and < 10% for follicular involvement

• MM patients who have stable disease with < 40% bone marrow involvement

• No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• White blood cell count (WBC) >3.0 x 10^9/L

• Absolute neutrophil count >1.5 x 10^9/L

• Platelet count >100 x 10^9/L

Exclusion Criteria (Abbreviated List):

• Brain metastases or carcinomatous meningitis

• Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]

• Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias

• Acute Infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States
2	Indiana Blood and Marrow Transplantation	Beech Grove	Indiana	United States
3	University of Rochester Medical Center	Rochester	New York	United States
4	Oregon Health and Science University	Portland	Oregon	United States
5	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States

Sponsors and Collaborators

• Genzyme, a Sanofi Company

Investigators

• Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00322387
• Other Study ID Numbers: AMD3100-2104
• First Posted: May 5, 2006
• Last Update Posted: Mar 13, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by , ,: Non-Hodgkin's Lymphoma; Multiple Myeloma; Stem cell mobilization
• Additional relevant MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Plerixafor

Study Results

Participant Flow

Recruitment Details	Patients with NHL or MM eligible for the study were recruited from 5 centers in the United States. The first patient was enrolled (signed informed consent) in April 2004 and the last patient's last study visit was July 2006.
Pre-assignment Detail	Forty-four participants were enrolled; four participants never received plerixafor treatment so are excluded from summary tables.

Arm/Group Title	Non-Hodgkin's Lymphoma (NHL)	Multiple Myeloma (MM)
Arm/Group Description	Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.	Participants with multiple myeloma were assigned to any of the 4 treatment arms.
Period Title: Treatment Period
STARTED	14	26
COMPLETED	14	25
NOT COMPLETED	0	1
Period Title: Treatment Period
STARTED	14	26
COMPLETED	12	23
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Non-Hodgkin's Lymphoma (NHL)	Multiple Myeloma (MM)	Total
Arm/Group Description	Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.	Participants with multiple myeloma were assigned to any of the 4 treatment arms.	Total of all reporting groups
Overall Participants	14	26	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.7 (10.8)	56.1 (7.6)	55.6 (8.7)
Sex: Female, Male (Count of Participants)
Female	8 57.1%	11 42.3%	19 47.5%
Male	6 42.9%	15 57.7%	21 52.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 7.7%	2 5%
Not Hispanic or Latino	14 100%	24 92.3%	38 95%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Description	Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
Time Frame	13 months

Outcome Measure Data

Analysis Population Description

Safety population who received at least one dose of plerixafor.

Arm/Group Title	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM	Non-Hodgkin's Lymphoma (NHL): Plerixafor AM	Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo	Multiple Myeloma (MM): Plerixafor PM	Multiple Myeloma (MM): Plerixafor AM	Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM	Multiple Myeloma (MM): Plerixafor After Chemo	All Participants
Arm/Group Description	Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.	Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.	Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.	Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.	Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.	Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.	Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
Measure Participants	7	6	1	12	9	1	4	40
Participants reporting ≥ 1 Adverse Event	7 50%	6 23.1%	1 2.5%	12 NaN	9 NaN	1 NaN	3 NaN	39 NaN
AE Severity (Mild)	3 21.4%	3 11.5%	0 0%	2 NaN	2 NaN	0 NaN	0 NaN	10 NaN
AE Severity (Moderate)	2 14.3%	1 3.8%	1 2.5%	6 NaN	3 NaN	0 NaN	2 NaN	15 NaN
AE Severity (Severe)	2 14.3%	2 7.7%	0 0%	4 NaN	4 NaN	1 NaN	1 NaN	14 NaN
AE Severity (Life Threatening)	1 7.1%	1 3.8%	0 0%	2 NaN	3 NaN	0 NaN	0 NaN	7 NaN
AE Relationship to Drug (Not related)	0 0%	5 19.2%	0 0%	0 NaN	2 NaN	0 NaN	2 NaN	9 NaN
AE Relationship to Drug (Probably not related)	3 21.4%	0 0%	0 0%	3 NaN	0 NaN	0 NaN	0 NaN	6 NaN
AE Relationship to Drug (Possibly related)	1 7.1%	0 0%	0 0%	3 NaN	5 NaN	0 NaN	0 NaN	9 NaN
AE Relationship to Drug (Probably related)	1 7.1%	1 3.8%	1 2.5%	3 NaN	1 NaN	0 NaN	0 NaN	7 NaN
AE Relationship to Drug (Definitely related)	2 14.3%	0 0%	0 0%	3 NaN	1 NaN	1 NaN	1 NaN	8 NaN

2. Secondary Outcome

Title	Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Description	The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Time Frame	Days 4-5 (first dose of plerixafor to apheresis)

Outcome Measure Data

Analysis Population Description

Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.

Arm/Group Title	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM	Non-Hodgkin's Lymphoma (NHL): Plerixafor AM	Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo	Multiple Myeloma (MM): Plerixafor PM	Multiple Myeloma (MM): Plerixafor AM	Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM	Multiple Myeloma (MM): Plerixafor After Chemo
Arm/Group Description	Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.	Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.	Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.	Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.	Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.	Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.	Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
Measure Participants	7	5	1	12	9	1	1
Mean (Standard Deviation) [ratio]	2.2 (0.8)	1.5 (0.8)	1.2 (0.0)	1.8 (0.4)	6.5 (14.7)	24.0 (0.0)	3.1 (0.0)

3. Secondary Outcome

Title	Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Description	Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

Intent to treat population. Six participants with MM had 2 transplants.

Arm/Group Title	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM	Non-Hodgkin's Lymphoma (NHL): Plerixafor AM	Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo	Multiple Myeloma (MM): Plerixafor PM	Multiple Myeloma (MM): Plerixafor AM	Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM	Multiple Myeloma (MM): Plerixafor After Chemo
Arm/Group Description	Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.	Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.	Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.	Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.	Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.	Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.	Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
Measure Participants	7	6	1	12	9	1	4
Measure transplants	7	6	1	14	12	2	4
≤ Day 12	6	4	0	14	9	1	0
Day 13 to Day 21	1	2	1	0	3	1	4
≥ Day 22	0	0	0	0	0	0	0

Adverse Events

Time Frame	Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, and the rest period.
Adverse Event Reporting Description	In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.
Arm/Group Title	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM		Non-Hodgkin's Lymphoma (NHL): Plerixafor AM		Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo		Multiple Myeloma (MM): Plerixafor PM		Multiple Myeloma (MM): Plerixafor AM		Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM		Multiple Myeloma (MM): Plerixafor After Chemo
Arm/Group Description	Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.		Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.		Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.		Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.		Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.		Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.		Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
All Cause Mortality
	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM		Non-Hodgkin's Lymphoma (NHL): Plerixafor AM		Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo		Multiple Myeloma (MM): Plerixafor PM		Multiple Myeloma (MM): Plerixafor AM		Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM		Multiple Myeloma (MM): Plerixafor After Chemo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM		Non-Hodgkin's Lymphoma (NHL): Plerixafor AM		Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo		Multiple Myeloma (MM): Plerixafor PM		Multiple Myeloma (MM): Plerixafor AM		Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM		Multiple Myeloma (MM): Plerixafor After Chemo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		2/12 (16.7%)		2/9 (22.2%)		0/1 (0%)		1/4 (25%)
Blood and lymphatic system disorders
Febrile neutropenia	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		2/9 (22.2%)		0/1 (0%)		1/4 (25%)
Gastrointestinal disorders
Nausea	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Vomiting	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Infections and infestations
Staphylococcal sepsis	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Renal and urinary disorders
Cystitis haemorrhagic	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM		Non-Hodgkin's Lymphoma (NHL): Plerixafor AM		Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo		Multiple Myeloma (MM): Plerixafor PM		Multiple Myeloma (MM): Plerixafor AM		Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM		Multiple Myeloma (MM): Plerixafor After Chemo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/7 (100%)		6/6 (100%)		1/1 (100%)		12/12 (100%)		9/9 (100%)		1/1 (100%)		2/4 (50%)
Blood and lymphatic system disorders
Anaemia	2/7 (28.6%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Thrombocytopenia	0/7 (0%)		3/6 (50%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Cardiac disorders
Tachycardia	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Ear and labyrinth disorders
Tinnitus	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Eye disorders
Eyelid oedema	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Vision blurred	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		1/1 (100%)		0/4 (0%)
Gastrointestinal disorders
Abdominal distension	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Abdominal pain	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Abdominal pain lower	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Abdominal pain upper	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Anal fistula	0/7 (0%)		0/6 (0%)		1/1 (100%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Diarrhoea	2/7 (28.6%)		1/6 (16.7%)		0/1 (0%)		6/12 (50%)		3/9 (33.3%)		1/1 (100%)		0/4 (0%)
Dyspepsia	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Flatulence	2/7 (28.6%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Gastrointestinal toxicity	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Haemorrhoids	0/7 (0%)		0/6 (0%)		1/1 (100%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Hypoaesthesia oral	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		1/9 (11.1%)		1/1 (100%)		0/4 (0%)
Nausea	4/7 (57.1%)		0/6 (0%)		0/1 (0%)		6/12 (50%)		7/9 (77.8%)		0/1 (0%)		1/4 (25%)
Paraesthesia oral	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Rectal fissure	0/7 (0%)		0/6 (0%)		1/1 (100%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Stomach discomfort	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Swollen tongue	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Vomiting	0/7 (0%)		0/6 (0%)		0/1 (0%)		2/12 (16.7%)		2/9 (22.2%)		0/1 (0%)		0/4 (0%)
General disorders
Asthenia	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		2/9 (22.2%)		0/1 (0%)		0/4 (0%)
Catheter related complication	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		3/9 (33.3%)		0/1 (0%)		0/4 (0%)
Catheter site discharge	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Catheter site erythema	0/7 (0%)		0/6 (0%)		1/1 (100%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Catheter site haemorrhage	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Catheter site pain	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Chills	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Disease progression	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Fatigue	1/7 (14.3%)		1/6 (16.7%)		0/1 (0%)		2/12 (16.7%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Infusion site vesicles	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Injection site bruising	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		2/9 (22.2%)		0/1 (0%)		0/4 (0%)
Injection site erythema	2/7 (28.6%)		0/6 (0%)		0/1 (0%)		2/12 (16.7%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Injection site pain	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Injection site pruritus	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Injection site urticaria	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		1/1 (100%)		0/4 (0%)
Local swelling	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Oedema peripheral	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		2/9 (22.2%)		0/1 (0%)		0/4 (0%)
Pain	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Pyrexia	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		2/9 (22.2%)		0/1 (0%)		0/4 (0%)
Infections and infestations
Clostridium difficile colitis	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Nail infection	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Onychomycosis	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Oral candidiasis	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Upper respiratory tract infection	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Vulvovaginal mycotic infection	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Injury, poisoning and procedural complications
Contusion	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Investigations
Blood lactate dehydrogenase increased	1/7 (14.3%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Carbon monoxide diffusing capacity decreased	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Platelet count decreased	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Weight increased	0/7 (0%)		0/6 (0%)		0/1 (0%)		2/12 (16.7%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Hyperuricaemia	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Hypocalcaemia	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Hypokalaemia	1/7 (14.3%)		1/6 (16.7%)		0/1 (0%)		1/12 (8.3%)		2/9 (22.2%)		0/1 (0%)		0/4 (0%)
Hypomagnesaemia	0/7 (0%)		2/6 (33.3%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/7 (0%)		0/6 (0%)		0/1 (0%)		3/12 (25%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Back pain	0/7 (0%)		2/6 (33.3%)		0/1 (0%)		2/12 (16.7%)		0/9 (0%)		0/1 (0%)		2/4 (50%)
Bone pain	4/7 (57.1%)		2/6 (33.3%)		0/1 (0%)		7/12 (58.3%)		7/9 (77.8%)		0/1 (0%)		0/4 (0%)
Joint swelling	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Kyphosis	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		1/4 (25%)
Muscle spasms	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Musculoskeletal chest pain	0/7 (0%)		2/6 (33.3%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Musculoskeletal discomfort	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Musculoskeletal pain	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		1/4 (25%)
Pain in extremity	1/7 (14.3%)		0/6 (0%)		1/1 (100%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Nervous system disorders
Dizziness	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		3/9 (33.3%)		0/1 (0%)		0/4 (0%)
Headache	5/7 (71.4%)		0/6 (0%)		1/1 (100%)		2/12 (16.7%)		3/9 (33.3%)		1/1 (100%)		0/4 (0%)
Hypoaesthesia	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Paraesthesia	3/7 (42.9%)		2/6 (33.3%)		1/1 (100%)		3/12 (25%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Sensory loss	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Syncope	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Psychiatric disorders
Anxiety	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Insomnia	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		3/9 (33.3%)		0/1 (0%)		0/4 (0%)
Nightmare	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Renal and urinary disorders
Nocturia	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Pollakiuria	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Reproductive system and breast disorders
Genital lesion	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		1/4 (25%)
Respiratory, thoracic and mediastinal disorders
Cough	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Dyspnoea	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Pharyngolaryngeal pain	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Rhinorrhoea	0/7 (0%)		0/6 (0%)		1/1 (100%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Sinus congestion	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Sneezing	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Wheezing	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Skin and subcutaneous tissue disorders
Cold sweat	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Ecchymosis	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Hyperhidrosis	0/7 (0%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		1/9 (11.1%)		0/1 (0%)		0/4 (0%)
Periorbital oedema	0/7 (0%)		0/6 (0%)		0/1 (0%)		1/12 (8.3%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Rash	1/7 (14.3%)		0/6 (0%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)
Vascular disorders
Hypotension	0/7 (0%)		1/6 (16.7%)		0/1 (0%)		0/12 (0%)		0/9 (0%)		0/1 (0%)		0/4 (0%)

Limitations/Caveats

The number and complexity of the cohorts make generalizations regarding the data problematic. Each cohort was small, and mobilizing and high-dose conditioning regimens varied across sites. AEs may include residual effects of chemotherapy.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.