AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult... | NCT00396331

NCT00396331

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

This is a Phase 2, multicenter, prospective, open-label study. Once 70 patients have enrolled, subsequent patients enrolled should have a diagnosis of lymphoma. Patients who would benefit from an autologous stem cell transplant, who have failed previous collections or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor (G-CSF) alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests, and who meet the inclusion/exclusion criteria are eligible to receive plerixafor as outlined in this protocol. The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of plerixafor on the evening prior to each day of apheresis.

Patients will undergo mobilization with G-CSF (10 µg/kg) for 4 days. On Day 4, plerixafor (240 µg/kg) will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until ≥2*10^6 CD34+ cells/kg are collected, whichever occurs first. In addition, the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of plerixafor will be examined.

After the last apheresis has been completed, or after the patient has collected ≥2*10^6 CD34+ cells/kg, he/she will be treated with high-dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF with plerixafor mobilization regimen. In the event that the minimum number of ≥2*10^6 cells for transplantation are not obtained from the first mobilization with plerixafor, cells may be retained and pooled for transplantation with those from a second mobilization with plerixafor (or from prior mobilization with other agents), at the investigator's discretion. If a second mobilization with plerixafor is attempted, a minimum rest interval of one week should be allowed between the last apheresis of the first regimen and the first dose of G-CSF of the second. The number of CD34+ cells mobilized in the peripheral blood (PB), collected in the apheresis product, and the number of apheresis sessions performed will be measured. Success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will be assessed for durability of their transplant for 12 months after transplantation.

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
G-CSF plus Plerixafor	Experimental		Drug: G-CSF plus plerixafor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-CSF plus plerixafor	Drug	Participants underwent mobilization with granulocyte colony-stimulating factor (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period	Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').	Day 1 to approximately day 38
Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF	Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.	Day 5 to Day 11 (up to 7 apheresis)
Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF	Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.	Day 5 to Day 11 (up to 7 aphereses)

Secondary Outcomes

Measure	Description	Time Frame
Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment	The number of days from transplantation to successful engraftment as measured by PMN >=0.510^9 /L for 3 days or >=1.010^9 /L for 1 day.	approximately 2 months (1 month post transplant)
Median Number of Days to Platelet (PLT) Engraftment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible to undergo autologous transplantation
Has failed previous collections or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor (G-CSF), chemotherapy and G-CSF or any other conventional therapy including cytokines, chemotherapy and cytokines or bone marrow harvest.
Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
≥3 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the purpose of this study) NOTE: Although thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the purpose of this study, none are to be administered within 7 days prior to the first dose of G-CSF (see Exclusion Criteria).
The patient has recovered from all acute toxic effects of prior chemotherapy
White blood cell count (WBC) >2.5*10^9/L
Absolute neutrophil count >1.5*10^9/L
Platelet count >85*10^9/L
Serum creatinine ≤1.5 mg/dl
Creatinine clearance >60 ml/min
Aspartate aminotransferase (AST), alanine transaminase (ALT) and total bilirubin <2x upper limit of normal (ULN)
Left ventricle ejection fraction >45% (by normal echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan)
Forced expiratory volume in one minute (FEV1) >60% of predicted or diffusion lung capacity for carbon monoxide (DLCO) ≥45% of predicted
No active infection of hepatitis B or C
Negative for HIV
Signed informed consent
Women of child-bearing potential agree to use an approved form of contraception

Exclusion Criteria:

Once 70 patients have enrolled, patients with diagnoses other than lymphoma are not eligible (eg, acute myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma).
A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
A residual acute medical condition resulting from prior chemotherapy
Received Neupogen™, thalidomide, dexamethasone, and/or Velcade™ within 7 days prior to the first dose of G-CSF
Brain metastases or carcinomatous meningitis
Acute infection
Fever (temperature >38°C/100.4°F)
Hypercalcaemia (>1 mg/dL above the ULN)
Positive pregnancy test in female patients
Lactating females
Patients of child-bearing potential unwilling to implement adequate birth control
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 protocol or who are currently enrolled in another experimental protocol during the Mobilization phase

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center'		Duarte	California	91010	United States
H. Lee Moffitt Cancer Center

References Module

No data available

No data is available for this block.

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	G-CSF Plus Plerixafor	Participants 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 7 aphereses or until ≥ 2*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	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
BG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
BG002	Multiple Myeloma	Participants with multiple myeloma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
BG003	Other Cancers	Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00066 BG00121 BG00210 BG0033 BG004100

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
	BG00057.0± 10.0 BG00145.6± 15.5 BG00262.6± 11.3 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00029 BG00110 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00060 BG00117 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

Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period

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

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

Posted

Number

Participants

Day 1 to approximately day 38

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG002	Multiple Myeloma	Participants with multiple myeloma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG003	Other Cancers	Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG004	All Patients

Units	Counts
Participants	OG00066 OG00121 OG00210 OG003

Title

Denominators

Categories

Participants Reporting At Least 1 AE

Title	Measurements
	OG00065 OG00120 OG0029 OG003

Primary

Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF

Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.

Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had 2 courses of apheresis.

Posted

Number

Proportion of Participants

Day 5 to Day 11 (up to 7 apheresis)

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Secondary

Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment

The number of days from transplantation to successful engraftment as measured by PMN >=0.5*10^9 /L for 3 days or >=1.0*10^9 /L for 1 day.

Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.

Posted

Median

Full Range

Days

approximately 2 months (1 month post transplant)

Transplants with PMN engraftment

Participants

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Secondary

Median Number of Days to Platelet (PLT) Engraftment

The number of days from transplantation to successful engraftment as measured by platelet value of >=20*10^9/L for 7 days without transfusion.

Participants who received a transplant and had a successful PLT engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Four transplants (2 in participants with NHL and 2 in participants with MM) did not result in PLT engraftment and are therefore not included in the analysis.

Posted

Median

Full Range

Days

Approximately 2 months (1 month post transplant)

Transplants with PLT engraftment

Participants

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Secondary

Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation

The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT >50*10^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level >= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) > 1,000 (1*10^9/L) with no G-CSF for at least 1 week prior to the visit.

Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to >50*10^9/L and 1 who had low hemoglobin at the 12-month visit.

Posted

Number

Participants

Approximately 13 months (12 months post transplant )

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Primary

Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF

Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.

Posted

Number

Proportion of Participants

Day 5 to Day 11 (up to 7 aphereses)

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Secondary

Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration

The number of participants with Bcl2 translocation in post-treatment samples.

NHL participants with known follicular or transformed (follicular to diffuse large cell) lymphoma who provided samples for tumor cell mobilization analysis.

Outcome is not reported because there were insufficient samples for analysis.

Posted

Up to Day 7

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF

Number of participants who had at least 2*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.

Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.

Posted

Number

Participants

Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Secondary

Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF

Number of participants who had at least 5*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.

Posted

Number

Participants

Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)

ID	Title	Description
OG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
OG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Secondary

Maximum Observed Plasma Concentration (Cmax) on Day 4

Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.

Participants who provided blood samples for pharmacokinetic (PK) analysis.

Posted

Mean

Standard Deviation

ng/mL

Day 4 (following first plerixafor administration)

ID	Title	Description
OG000	PK Subpopulation	Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Plasma Concentration (Cmax) on Day 7

Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.

Participants who provided blood samples for pharmacokinetic (PK) analysis.

Posted

Mean

Standard Deviation

ng/mL

Day 7 (following fourth plerixafor administration)

ID	Title	Description
OG000	PK Subpopulation	Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Secondary

Time to Maximum Plasma Concentration (Tmax) on Day 4

Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data

Participants who provided blood samples for pharmacokinetic (PK) analysis.

Posted

Median

Full Range

Hours

Day 4 (following first plerixafor administration)

ID	Title	Description
OG000	PK Subpopulation	Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Secondary

Time to Maximum Plasma Concentration (Tmax) on Day 7

Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data

Participants who provided blood samples for pharmacokinetic (PK) analysis.

Posted

Median

Full Range

Hours

Day 7 (following fourth plerixafor administration)

ID	Title	Description
OG000	PK Subpopulation	Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Secondary

Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4

Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.

Participants who provided blood samples for pharmacokinetic (PK) analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Days 4 -5 (following first plerixafor administration)

ID	Title	Description
OG000	PK Subpopulation	Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Secondary

Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7

Participants who provided blood samples for pharmacokinetic (PK) analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Days 7-8 (following fourth plerixafor administration)

ID	Title	Description
OG000	PK Subpopulation	Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Non-Hodgkin's Lymphoma	Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.	4	66	64	66
EG001	Hodgkin's Disease	Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.	0	21	20	21
EG002	Multiple Myeloma	Participants with multiple myeloma (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.	1	10	9	10
EG003	Other Cancers	Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) 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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.	1	3	3	3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG0030 affected3 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Catheter site infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Central line infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG0030 affected3 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Cardiac flutter	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Palpitations	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Diplopia	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Eye swelling	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Ocular icterus	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00021 affected66 at risk EG0017 affected21 at risk EG0024 affected10 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0013 affected21 at risk EG0020 affected10 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected66 at risk EG0014 affected21 at risk EG0020 affected10 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected66 at risk EG0013 affected21 at risk EG0020 affected10 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00015 affected66 at risk EG0016 affected21 at risk EG0023 affected10 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected66 at risk EG0012 affected21 at risk EG0020 affected10 at risk EG003
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Catheter related complication	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Catheter site erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Catheter site pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0011 affected21 at risk EG0022 affected10 at risk EG003
Catheter thrombosis	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Chest discomfort	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Discomfort	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG00028 affected66 at risk EG0018 affected21 at risk EG0024 affected10 at risk EG003
Feeling jittery	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Influenza like illness	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Infusion site erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site discolouration	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG00018 affected66 at risk EG0016 affected21 at risk EG0022 affected10 at risk EG003
Injection site haematoma	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0011 affected21 at risk EG0021 affected10 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Injection site inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site paraesthesia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site pruritus	General disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site reaction	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Injection site swelling	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Malaise	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Oedema	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected66 at risk EG0013 affected21 at risk EG0021 affected10 at risk EG003
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0012 affected21 at risk EG0020 affected10 at risk EG003
Laryngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Pneumocystis jiroveci infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Wound secretion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Blood culture positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Blood pressure decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Blood urea increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Body temperature increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Breath sounds abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Cardiac murmur	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Culture positive	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0003 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Platelet count decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected66 at risk EG0012 affected21 at risk EG0022 affected10 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected66 at risk EG0013 affected21 at risk EG0023 affected10 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0009 affected66 at risk EG0012 affected21 at risk EG0021 affected10 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0012 affected21 at risk EG0021 affected10 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00017 affected66 at risk EG0017 affected21 at risk EG0022 affected10 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0011 affected21 at risk EG0022 affected10 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0012 affected21 at risk EG0020 affected10 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0012 affected21 at risk EG0020 affected10 at risk EG003
Testicular choriocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected66 at risk EG0013 affected21 at risk EG0020 affected10 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected66 at risk EG0014 affected21 at risk EG0022 affected10 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Lethargy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected66 at risk EG0016 affected21 at risk EG0021 affected10 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected66 at risk EG0010 affected21 at risk EG0022 affected10 at risk EG003
Depression	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0011 affected21 at risk EG0021 affected10 at risk EG003
Dysphoria	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected66 at risk EG0013 affected21 at risk EG0022 affected10 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected66 at risk EG0012 affected21 at risk EG0020 affected10 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0014 affected21 at risk EG0020 affected10 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0012 affected21 at risk EG0020 affected10 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0011 affected21 at risk EG0020 affected10 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Flushing	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Hot flush	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected66 at risk EG0010 affected21 at risk EG0021 affected10 at risk EG003
Neovascularisation	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003
Pallor	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected66 at risk EG0010 affected21 at risk EG0020 affected10 at risk EG003

ID	Term
D009101	Multiple Myeloma
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

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

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