Mobilization of Stem Cells With AMD3100 (Plerixafor) and... | NCT00322491

NCT00322491

Status Module

Sponsor/Collaborators Module

Name	Class
AnorMED	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Hodgkin's Lymphoma (NHL)	Experimental	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Drug: G-CSF Plus Plerixafor
Multiple Myeloma (MM)	Experimental	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Drug: G-CSF Plus Plerixafor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-CSF Plus Plerixafor	Drug	Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)	Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').	Day 1 to approximately Day 38 (before start of chemotherapy)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor	The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)	Days 4-5 (first dose of plerixafor to apheresis)

Other Outcomes

Measure	Description	Time Frame
Median Cumulative Number of CD34+ Cells Collected During Apheresis	Median cumulative total number of CD34+ cells collected during apheresis.	Days 5-8
Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
No more than 3 prior regimens of chemotherapy
More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
White blood cell (WBC) count >3.0*10^9/L
Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
Platelet (PLT) count >100*10^9/L
Serum creatinine <=2.2 mg/dL
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted
Negative for human immunodeficiency virus (HIV) type 1
Women of child bearing potential agreed to use an approved form of contraception.

Exclusion Criteria:

Patients who have failed previous collections
Brain metastases or carcinomatous meningitis
History of ventricular arrhythmias
A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
A residual acute medical condition resulting from prior chemotherapy
Acute infection
Fever (temp >38°C/100.4°F)
Patients whose actual body weight exceeds 175% of their ideal body weight
Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
Positive pregnancy test in female patients
Lactating females
Patients of child-bearing potential unwilling to implement adequate birth control.
Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas		United States
UCLA School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19167685	Result	Stiff P, Micallef I, McCarthy P, Magalhaes-Silverman M, Weisdorf D, Territo M, Badel K, Calandra G. Treatment with plerixafor in non-Hodgkin's lymphoma and multiple myeloma patients to increase the number of peripheral blood stem cells when given a mobilizing regimen of G-CSF: implications for the heavily pretreated patient. Biol Blood Marrow Transplant. 2009 Feb;15(2):249-56. doi: 10.1016/j.bbmt.2008.11.028.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
BG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00023 BG00126 BG00249

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.5± 8.7 BG00157.6± 8.1 BG00257.1± 8.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG00110 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00023 BG00123 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)

Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').

Safety population - all participants who received at least 1 dose of plerixafor.

Posted

Number

participants

Day 1 to approximately Day 38 (before start of chemotherapy)

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG002	All Participants

Units	Counts
Participants	OG00023 OG00126 OG00249

Title

Denominators

Categories

Participants reporting ≥ 1 Adverse Event

Title	Measurements
	OG00023 OG00126 OG00249

AE Severity (Mild)

Secondary

Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor

The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)

The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).

Posted

Number

participants

Days 4-5 (first dose of plerixafor to apheresis)

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Other Pre-specified

Median Cumulative Number of CD34+ Cells Collected During Apheresis

Median cumulative total number of CD34+ cells collected during apheresis.

Participants who received at least one dose of plerixafor

Posted

Median

Full Range

CD34+ cells (*10^6 / kg)

Days 5-8

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG002	All Participants

Secondary

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

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.

Participants who received a transplant. Two participants in the MM group received a second transplant.

Posted

Number

number of transplants

2 months

transplants

Participants

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Other Pre-specified

Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant

Participants were monitored for platelet (PLT) 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.

A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.

Posted

Number

number of transplants

2 months

transplants

Participants

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Other Pre-specified

Number of Participants With Durable Engraftment 12 Months After Transplantation

The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.

Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.

Posted

Number

participants

Approximately 13 months (12 months post-transplant )

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Non-Hodgkin's Lymphoma (NHL)	Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.			0	23	23	23
EG001	Multiple Myeloma (MM)	Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.			1	26	26	26

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Heparin-induced thrombocytopenia	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected23 at risk EG0011 affected26 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected23 at risk EG0015 affected26 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0015 affected26 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected23 at risk EG0013 affected26 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Ocular hyperaemia	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected23 at risk EG0010 affected26 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected23 at risk EG00110 affected26 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected26 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0011 affected26 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected23 at risk EG0018 affected26 at risk
Oral pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0013 affected26 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Catheter related complication	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Catheter site discharge	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Catheter site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Catheter site haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected26 at risk
Catheter site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected26 at risk
Catheter site pruritus	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Catheter site related reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Catheter thrombosis	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Chest discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected23 at risk EG0014 affected26 at risk
Feeling cold	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Hunger	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected26 at risk
Injection site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected23 at risk EG0013 affected26 at risk
Injection site haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected26 at risk
Injection site irritation	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Injection site pruritus	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Injection site swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Irritability	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0012 affected26 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0011 affected26 at risk
Secretion discharge	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Catheter related infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Oral candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Tooth abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Blood stem cell harvest failure	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Post procedural discomfort	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Bacteria stool identified	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Blood alkaline phosphatase decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0013 affected26 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0016 affected26 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Blood magnesium decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Haemoglobin decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected26 at risk
Heart rate irregular	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Lymphocyte count abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
White blood cell count increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected26 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected23 at risk EG0012 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected23 at risk EG0011 affected26 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected23 at risk EG0016 affected26 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0013 affected26 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0012 affected26 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected23 at risk EG0014 affected26 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected26 at risk
Migraine	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected23 at risk EG00111 affected26 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected26 at risk
Sinus headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Tremor	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0012 affected26 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected23 at risk EG0016 affected26 at risk
Nervousness	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0012 affected26 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0013 affected26 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0012 affected26 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected26 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected26 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected23 at risk EG0011 affected26 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected26 at risk
Haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk
Hot flush	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected26 at risk

ID	Term
D008228	Lymphoma, Non-Hodgkin
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D054219	Neoplasms, Plasma Cell
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006474	Hemorrhagic Disorders

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
C088327	plerixafor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

Units	Counts
Participants	OG00023 OG00126 OG00249