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AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts

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ClinicalTrials.gov Identifier: NCT00396331
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : December 2, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autologous Stem Cell Transplantation
Intervention Drug: G-CSF plus plerixafor
Enrollment 100
Recruitment Details  
Pre-assignment Details Four participants were enrolled in the study but never received plerixafor treatment so are not included below. Reasons for not receiving plerixafor included disease progression (2), infection (1) and insurance issues (1).
Arm/Group Title G-CSF Plus Plerixafor
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 100
Number of Participants Treated 100
Number of Participants Transplanted 87 [1]
Completed 68
Not Completed 32
Reason Not Completed
Failed to mobilize - no transplant             8
Did not go on to transplant             5
Lost to Follow-up             3
Death             16
[1]
7 participants had two transplants
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 66 21 10 3 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 21 participants 10 participants 3 participants 100 participants
57.0  (10.0) 45.6  (15.5) 62.6  (11.3) 32.7  (28.9) 54.4  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 21 participants 10 participants 3 participants 100 participants
Female
29
  43.9%
10
  47.6%
5
  50.0%
1
  33.3%
45
  45.0%
Male
37
  56.1%
11
  52.4%
5
  50.0%
2
  66.7%
55
  55.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 21 participants 10 participants 3 participants 100 participants
Caucasian 60 17 9 3 89
Black or African American 3 1 1 0 5
Asian 2 1 0 0 3
Hispanic/Latino 1 2 0 0 3
1.Primary Outcome
Title Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period
Hide Description 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').
Time Frame Day 1 to approximately day 38
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population of all participants who received at least 1 dose of plerixafor.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 66 21 10 3 100
Measure Type: Number
Unit of Measure: Participants
Participants Reporting At Least 1 AE 65 20 9 3 97
Adverse Events by Severity -Mild 42 12 7 1 62
Adverse Events by Severity -Moderate 18 8 1 0 27
Adverse Events by Severity -Severe 5 0 1 2 8
Adverse Events by Severity -Life Threatening 0 0 0 0 0
AE Relationship to Study Drug -Not Related 10 4 4 0 18
AE Relationship to Study Drug-Probably Not Related 8 2 1 0 11
AE Relationship to Study Drug -Possibly Related 16 4 1 0 21
AE Relationship to Study Drug -Probably Related 22 2 2 1 27
AE Relationship to Study Drug -Definitely Related 9 8 1 2 20
2.Primary Outcome
Title Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
Hide Description Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.
Time Frame Day 5 to Day 11 (up to 7 apheresis)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 66 21 10 3 100
Measure Type: Number
Unit of Measure: Proportion of Participants
.773 .714 1.00 .667 .780
3.Primary Outcome
Title Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
Hide Description Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.
Time Frame Day 5 to Day 11 (up to 7 aphereses)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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 two courses of apheresis.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 66 21 10 3 100
Measure Type: Number
Unit of Measure: Proportion of Participants
0.288 0.429 0.70 0.667 0.37
4.Secondary Outcome
Title Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Hide Description 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.
Time Frame approximately 2 months (1 month post transplant)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 60 16 8 1 85
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants with PMN engraftment
60 20 10 2 92
Median (Full Range)
Unit of Measure: Days
12.0
(2.0 to 19.0)
12.0
(11.0 to 15.0)
13.0
(9.0 to 16.0)
10.0
(7.0 to 13.0)
12.0
(2.0 to 19.0)
5.Secondary Outcome
Title Median Number of Days to Platelet (PLT) Engraftment
Hide Description The number of days from transplantation to successful engraftment as measured by platelet value of >=20*10^9/L for 7 days without transfusion.
Time Frame Approximately 2 months (1 month post transplant)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 59 16 7 1 83
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants with PLT engraftment
59 20 9 2 90
Median (Full Range)
Unit of Measure: Days
21.0
(7.0 to 88.0)
21.0
(15.0 to 81.0)
19.0
(16.0 to 24.0)
26.0
(3.0 to 49.0)
21.0
(3.0 to 88.0)
6.Secondary Outcome
Title Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation
Hide Description 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.
Time Frame Approximately 13 months (12 months post transplant )
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 46 14 8 0 68
Measure Type: Number
Unit of Measure: Participants
44 14 7 65
7.Secondary Outcome
Title Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration
Hide Description The number of participants with Bcl2 translocation in post-treatment samples.
Time Frame Up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Non-Hodgkin's Lymphoma
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF
Time Frame Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 66 21 10 3 100
Measure Type: Number
Unit of Measure: Participants
54 18 10 2 84
9.Secondary Outcome
Title Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF
Time Frame Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers All Patients
Hide Arm/Group Description:
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.
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.
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 66 21 10 3 100
Measure Type: Number
Unit of Measure: Participants
21 9 7 2 39
10.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) on Day 4
Hide Description Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.
Time Frame Day 4 (following first plerixafor administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
Arm/Group Title PK Subpopulation
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
796  (305)
11.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) on Day 7
Hide Description Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.
Time Frame Day 7 (following fourth plerixafor administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
Arm/Group Title PK Subpopulation
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
894  (227)
12.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) on Day 4
Hide Description Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data
Time Frame Day 4 (following first plerixafor administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
Arm/Group Title PK Subpopulation
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: Hours
0.500
(0.0500 to .750)
13.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) on Day 7
Hide Description Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data
Time Frame Day 7 (following fourth plerixafor administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
Arm/Group Title PK Subpopulation
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: Hours
0.500
(0.417 to 0.600)
14.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4
Hide Description 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.
Time Frame Days 4 -5 (following first plerixafor administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
Arm/Group Title PK Subpopulation
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
4578  (1715)
15.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7
Hide Description 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.
Time Frame Days 7-8 (following fourth plerixafor administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
Arm/Group Title PK Subpopulation
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5496  (1339)
Time Frame First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration, and the rest period.
Adverse Event Reporting Description

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Each AE table includes all events, regardless of reported relationship to study treatment or grade.

 
Arm/Group Title Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/66 (6.06%)   0/21 (0.00%)   1/10 (10.00%)   1/3 (33.33%) 
Cardiac disorders         
Atrial fibrillation  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Intestinal obstruction  1  0/66 (0.00%)  0/21 (0.00%)  0/10 (0.00%)  1/3 (33.33%) 
Pancreatitis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Infections and infestations         
Catheter site infection  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Central line infection  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia aspiration  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Other Cancers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/66 (96.97%)   20/21 (95.24%)   9/10 (90.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  1/66 (1.52%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Leukocytosis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Lymph node pain  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Lymphadenopathy  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Neutropenia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Thrombocytopenia  1  4/66 (6.06%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Cardiac disorders         
Arrhythmia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Atrial fibrillation  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Cardiac flutter  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Palpitations  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Tachycardia  1  1/66 (1.52%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Ear and labyrinth disorders         
Tinnitus  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Eye disorders         
Diplopia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Erythema of eyelid  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Eye swelling  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Ocular icterus  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Abdominal distension  1  4/66 (6.06%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Abdominal pain  1  4/66 (6.06%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Constipation  1  5/66 (7.58%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Diarrhoea  1  21/66 (31.82%)  7/21 (33.33%)  4/10 (40.00%)  0/3 (0.00%) 
Dry mouth  1  4/66 (6.06%)  3/21 (14.29%)  0/10 (0.00%)  0/3 (0.00%) 
Dyspepsia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Flatulence  1  8/66 (12.12%)  4/21 (19.05%)  0/10 (0.00%)  0/3 (0.00%) 
Frequent bowel movements  1  5/66 (7.58%)  3/21 (14.29%)  0/10 (0.00%)  0/3 (0.00%) 
Hypoaesthesia oral  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Nausea  1  15/66 (22.73%)  6/21 (28.57%)  3/10 (30.00%)  1/3 (33.33%) 
Paraesthesia oral  1  5/66 (7.58%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Retching  1  1/66 (1.52%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Toothache  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Vomiting  1  5/66 (7.58%)  2/21 (9.52%)  0/10 (0.00%)  1/3 (33.33%) 
General disorders         
Asthenia  1  4/66 (6.06%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Catheter related complication  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Catheter site erythema  1  1/66 (1.52%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Catheter site pain  1  4/66 (6.06%)  1/21 (4.76%)  2/10 (20.00%)  1/3 (33.33%) 
Catheter thrombosis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Chest discomfort  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Chills  1  3/66 (4.55%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Discomfort  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Fatigue  1  28/66 (42.42%)  8/21 (38.10%)  4/10 (40.00%)  2/3 (66.67%) 
Feeling jittery  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Influenza like illness  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Infusion site erythema  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Injection site discolouration  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Injection site erythema  1  18/66 (27.27%)  6/21 (28.57%)  2/10 (20.00%)  1/3 (33.33%) 
Injection site haematoma  1  4/66 (6.06%)  1/21 (4.76%)  1/10 (10.00%)  0/3 (0.00%) 
Injection site haemorrhage  1  1/66 (1.52%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Injection site inflammation  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Injection site pain  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  2/3 (66.67%) 
Injection site paraesthesia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Injection site pruritus  1  5/66 (7.58%)  0/21 (0.00%)  0/10 (0.00%)  2/3 (66.67%) 
Injection site reaction  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Injection site swelling  1  1/66 (1.52%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Malaise  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Non-cardiac chest pain  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Oedema  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Oedema peripheral  1  6/66 (9.09%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Pain  1  7/66 (10.61%)  3/21 (14.29%)  1/10 (10.00%)  0/3 (0.00%) 
Pyrexia  1  1/66 (1.52%)  2/21 (9.52%)  0/10 (0.00%)  0/3 (0.00%) 
Infections and infestations         
Laryngitis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Onychomycosis  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Oral candidiasis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Pneumocystis jiroveci infection  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Urinary tract infection  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications         
Allergic transfusion reaction  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Contusion  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Wound secretion  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Investigations         
Aspartate aminotransferase increased  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Blood alkaline phosphatase increased  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Blood culture positive  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Blood pressure decreased  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Blood urea increased  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Body temperature increased  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Breath sounds abnormal  1  0/66 (0.00%)  0/21 (0.00%)  0/10 (0.00%)  1/3 (33.33%) 
Cardiac murmur  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Culture positive  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Haemoglobin decreased  1  3/66 (4.55%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Oxygen saturation decreased  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Platelet count decreased  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders         
Cachexia  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Decreased appetite  1  4/66 (6.06%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Electrolyte imbalance  1  1/66 (1.52%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Fluid overload  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Gout  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Hyperuricaemia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Hypokalaemia  1  13/66 (19.70%)  2/21 (9.52%)  2/10 (20.00%)  2/3 (66.67%) 
Hypomagnesaemia  1  13/66 (19.70%)  3/21 (14.29%)  3/10 (30.00%)  1/3 (33.33%) 
Hypophosphataemia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  9/66 (13.64%)  2/21 (9.52%)  1/10 (10.00%)  0/3 (0.00%) 
Back pain  1  4/66 (6.06%)  2/21 (9.52%)  1/10 (10.00%)  0/3 (0.00%) 
Bone pain  1  17/66 (25.76%)  7/21 (33.33%)  2/10 (20.00%)  0/3 (0.00%) 
Joint stiffness  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Muscle spasms  1  2/66 (3.03%)  1/21 (4.76%)  2/10 (20.00%)  0/3 (0.00%) 
Muscular weakness  1  2/66 (3.03%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Musculoskeletal chest pain  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Musculoskeletal discomfort  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Musculoskeletal pain  1  1/66 (1.52%)  2/21 (9.52%)  0/10 (0.00%)  0/3 (0.00%) 
Musculoskeletal stiffness  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Myalgia  1  2/66 (3.03%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Neck pain  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Pain in extremity  1  1/66 (1.52%)  2/21 (9.52%)  0/10 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Testicular choriocarcinoma  1  0/66 (0.00%)  0/21 (0.00%)  0/10 (0.00%)  1/3 (33.33%) 
Nervous system disorders         
Dizziness  1  7/66 (10.61%)  3/21 (14.29%)  0/10 (0.00%)  0/3 (0.00%) 
Dysgeusia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Headache  1  14/66 (21.21%)  4/21 (19.05%)  2/10 (20.00%)  0/3 (0.00%) 
Hypoaesthesia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Lethargy  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Neuropathy peripheral  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Paraesthesia  1  11/66 (16.67%)  6/21 (28.57%)  1/10 (10.00%)  0/3 (0.00%) 
Restless legs syndrome  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Sinus headache  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
Anxiety  1  7/66 (10.61%)  0/21 (0.00%)  2/10 (20.00%)  1/3 (33.33%) 
Depression  1  1/66 (1.52%)  1/21 (4.76%)  1/10 (10.00%)  0/3 (0.00%) 
Dysphoria  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Insomnia  1  7/66 (10.61%)  3/21 (14.29%)  2/10 (20.00%)  0/3 (0.00%) 
Restlessness  1  1/66 (1.52%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Renal and urinary disorders         
Urine odour abnormal  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders         
Pelvic pain  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/66 (4.55%)  2/21 (9.52%)  0/10 (0.00%)  1/3 (33.33%) 
Dysphonia  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Dyspnoea  1  4/66 (6.06%)  0/21 (0.00%)  0/10 (0.00%)  1/3 (33.33%) 
Dyspnoea exertional  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Epistaxis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Oropharyngeal pain  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Paranasal sinus hypersecretion  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Pleural effusion  1  0/66 (0.00%)  0/21 (0.00%)  0/10 (0.00%)  1/3 (33.33%) 
Postnasal drip  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Rales  1  3/66 (4.55%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Rhinorrhoea  1  2/66 (3.03%)  0/21 (0.00%)  1/10 (10.00%)  1/3 (33.33%) 
Sneezing  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders         
Blister  1  0/66 (0.00%)  0/21 (0.00%)  0/10 (0.00%)  1/3 (33.33%) 
Dry skin  1  2/66 (3.03%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Ecchymosis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Erythema  1  1/66 (1.52%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Hyperhidrosis  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Hypoaesthesia facial  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Night sweats  1  4/66 (6.06%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Pruritus  1  1/66 (1.52%)  4/21 (19.05%)  0/10 (0.00%)  0/3 (0.00%) 
Pruritus generalised  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Rash  1  1/66 (1.52%)  2/21 (9.52%)  0/10 (0.00%)  0/3 (0.00%) 
Rash macular  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Rash papular  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Skin discolouration  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Skin lesion  1  0/66 (0.00%)  1/21 (4.76%)  0/10 (0.00%)  0/3 (0.00%) 
Swelling face  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Flushing  1  4/66 (6.06%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Hot flush  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Hypertension  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Hypotension  1  0/66 (0.00%)  0/21 (0.00%)  1/10 (10.00%)  0/3 (0.00%) 
Neovascularisation  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Pallor  1  1/66 (1.52%)  0/21 (0.00%)  0/10 (0.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI agrees to submit the draft of any proposed public release or proposed publication to Genzyme and Genzyme may review the proposed public release or draft of the publication for up to 30 days prior to submission for public release, presentation or use. PI agrees (1) to withhold submission for an additional period not to exceed 60 days to allow Genzyme to take action to protect patent rights or trade secret rights (2) to give due consideration to any editorial comments of Genzyme.
Results Point of Contact
Name/Title: Medical Monitor
Organization: Genzyme
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00396331     History of Changes
Other Study ID Numbers: AMD31002112
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: November 2, 2010
Results First Posted: December 2, 2010
Last Update Posted: March 13, 2014