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Trial record 1 of 1 for:    amd3100-2104
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Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

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ClinicalTrials.gov Identifier: NCT00322387
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : July 14, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Non-Hodgkin
Multiple Myeloma
Intervention Drug: G-CSF and plerixafor
Enrollment 40
Recruitment Details Patients with NHL or MM eligible for the study were recruited from 5 centers in the United States. The first patient was enrolled (signed informed consent) in April 2004 and the last patient's last study visit was July 2006.
Pre-assignment Details Forty-four participants were enrolled; four participants never received plerixafor treatment so are excluded from summary tables.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Hide Arm/Group Description Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms. Participants with multiple myeloma were assigned to any of the 4 treatment arms.
Period Title: Treatment Period
Started 14 [1] 26 [2]
Completed 14 [3] 25 [3]
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
[1]
Plerixafor PM=7, Plerixafor AM=6, Low CD34+ Count/Plerixafor PM=0, and Plerixafor After Chemo=1
[2]
Plerixafor PM=12, Plerixafor AM=9, Low CD34+ Count/Plerixafor PM=1, and Plerixafor After Chemo=4
[3]
Completed refers to completed all treatment visits.
Period Title: Follow-up Period
Started 14 [1] 26 [2]
Completed 12 [3] 23 [3]
Not Completed 2 3
Reason Not Completed
Final assessment not done             1             3
Death             1             0
[1]
Participants who had transplants
[2]
Participants who had transplants. One participant did not complete therapy but had a transplant.
[3]
Follow-up visit 12 months post-transplant
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) Total
Hide Arm/Group Description Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms. Participants with multiple myeloma were assigned to any of the 4 treatment arms. Total of all reporting groups
Overall Number of Baseline Participants 14 26 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 26 participants 40 participants
54.7  (10.8) 56.1  (7.6) 55.6  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 26 participants 40 participants
Female
8
  57.1%
11
  42.3%
19
  47.5%
Male
6
  42.9%
15
  57.7%
21
  52.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 26 participants 40 participants
Hispanic or Latino
0
   0.0%
2
   7.7%
2
   5.0%
Not Hispanic or Latino
14
 100.0%
24
  92.3%
38
  95.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Hide Description Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population who received at least one dose of plerixafor.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo All Participants
Hide Arm/Group Description:
Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

[Not Specified]
Overall Number of Participants Analyzed 7 6 1 12 9 1 4 40
Measure Type: Number
Unit of Measure: participants
Participants reporting ≥ 1 Adverse Event 7 6 1 12 9 1 3 39
AE Severity (Mild) 3 3 0 2 2 0 0 10
AE Severity (Moderate) 2 1 1 6 3 0 2 15
AE Severity (Severe) 2 2 0 4 4 1 1 14
AE Severity (Life Threatening) 1 1 0 2 3 0 0 7
AE Relationship to Drug (Not related) 0 5 0 0 2 0 2 9
AE Relationship to Drug (Probably not related) 3 0 0 3 0 0 0 6
AE Relationship to Drug (Possibly related) 1 0 0 3 5 0 0 9
AE Relationship to Drug (Probably related) 1 1 1 3 1 0 0 7
AE Relationship to Drug (Definitely related) 2 0 0 3 1 1 1 8
2.Secondary Outcome
Title Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Hide Description The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Time Frame Days 4-5 (first dose of plerixafor to apheresis)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo
Hide Arm/Group Description:
Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Overall Number of Participants Analyzed 7 5 1 12 9 1 1
Mean (Standard Deviation)
Unit of Measure: ratio
2.2  (0.8) 1.5  (0.8) 1.2  (0.0) 1.8  (0.4) 6.5  (14.7) 24.0  (0.0) 3.1  (0.0)
3.Secondary Outcome
Title Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Hide Description Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Six participants with MM had 2 transplants.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo
Hide Arm/Group Description:
Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Overall Number of Participants Analyzed 7 6 1 12 9 1 4
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants
7 6 1 14 12 2 4
Measure Type: Number
Unit of Measure: transplants
≤ Day 12 6 4 0 14 9 1 0
Day 13 to Day 21 1 2 1 0 3 1 4
≥ Day 22 0 0 0 0 0 0 0
Time Frame Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, and the rest period.
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.
 
Arm/Group Title Non-Hodgkin's Lymphoma (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo
Hide Arm/Group Description Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen.

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Participants with MM who followed the Plerixafor After Chemo treatment arm regimen.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

All-Cause Mortality
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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 (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   0/6 (0.00%)   0/1 (0.00%)   2/12 (16.67%)   2/9 (22.22%)   0/1 (0.00%)   1/4 (25.00%) 
Blood and lymphatic system disorders               
Febrile neutropenia  1 [1]  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  0/1 (0.00%)  1/4 (25.00%) 
Gastrointestinal disorders               
Nausea  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Vomiting  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Infections and infestations               
Staphylococcal sepsis  1 [2]  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders               
Cystitis haemorrhagic  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Five participants experienced neutropenia starting before the first dose of plerixafor.
[2]
One participant experienced stapylococcal sepsis immediately after salvage chemotherapy 24 days after the participant received plerixafor.
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 (NHL): Plerixafor PM Non-Hodgkin's Lymphoma (NHL): Plerixafor AM Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo Multiple Myeloma (MM): Plerixafor PM Multiple Myeloma (MM): Plerixafor AM Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM Multiple Myeloma (MM): Plerixafor After Chemo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   6/6 (100.00%)   1/1 (100.00%)   12/12 (100.00%)   9/9 (100.00%)   1/1 (100.00%)   2/4 (50.00%) 
Blood and lymphatic system disorders               
Anaemia  1  2/7 (28.57%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Thrombocytopenia  1  0/7 (0.00%)  3/6 (50.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Cardiac disorders               
Tachycardia  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Ear and labyrinth disorders               
Tinnitus  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Eye disorders               
Eyelid oedema  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Vision blurred  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/1 (100.00%)  0/4 (0.00%) 
Gastrointestinal disorders               
Abdominal distension  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Abdominal pain  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Abdominal pain lower  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Abdominal pain upper  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Anal fistula  1  0/7 (0.00%)  0/6 (0.00%)  1/1 (100.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  2/7 (28.57%)  1/6 (16.67%)  0/1 (0.00%)  6/12 (50.00%)  3/9 (33.33%)  1/1 (100.00%)  0/4 (0.00%) 
Dyspepsia  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Flatulence  1  2/7 (28.57%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Gastrointestinal toxicity  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Haemorrhoids  1  0/7 (0.00%)  0/6 (0.00%)  1/1 (100.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Hypoaesthesia oral  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  1/1 (100.00%)  0/4 (0.00%) 
Nausea  1  4/7 (57.14%)  0/6 (0.00%)  0/1 (0.00%)  6/12 (50.00%)  7/9 (77.78%)  0/1 (0.00%)  1/4 (25.00%) 
Paraesthesia oral  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Rectal fissure  1  0/7 (0.00%)  0/6 (0.00%)  1/1 (100.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Stomach discomfort  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Swollen tongue  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Vomiting  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  2/12 (16.67%)  2/9 (22.22%)  0/1 (0.00%)  0/4 (0.00%) 
General disorders               
Asthenia  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  0/1 (0.00%)  0/4 (0.00%) 
Catheter related complication  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  3/9 (33.33%)  0/1 (0.00%)  0/4 (0.00%) 
Catheter site discharge  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Catheter site erythema  1  0/7 (0.00%)  0/6 (0.00%)  1/1 (100.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Catheter site haemorrhage  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Catheter site pain  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Chills  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Disease progression  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Fatigue  1  1/7 (14.29%)  1/6 (16.67%)  0/1 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Infusion site vesicles  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Injection site bruising  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  0/1 (0.00%)  0/4 (0.00%) 
Injection site erythema  1  2/7 (28.57%)  0/6 (0.00%)  0/1 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Injection site pain  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Injection site pruritus  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Injection site urticaria  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/1 (100.00%)  0/4 (0.00%) 
Local swelling  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Oedema peripheral  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  0/1 (0.00%)  0/4 (0.00%) 
Pain  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Pyrexia  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  0/1 (0.00%)  0/4 (0.00%) 
Infections and infestations               
Clostridium difficile colitis  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Nail infection  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Onychomycosis  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Oral candidiasis  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Upper respiratory tract infection  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Vulvovaginal mycotic infection  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications               
Contusion  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Investigations               
Blood lactate dehydrogenase increased  1  1/7 (14.29%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Carbon monoxide diffusing capacity decreased  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Platelet count decreased  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Weight increased  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Hyperuricaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Hypocalcaemia  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Hypokalaemia  1  1/7 (14.29%)  1/6 (16.67%)  0/1 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  0/1 (0.00%)  0/4 (0.00%) 
Hypomagnesaemia  1  0/7 (0.00%)  2/6 (33.33%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  3/12 (25.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Back pain  1  0/7 (0.00%)  2/6 (33.33%)  0/1 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  0/1 (0.00%)  2/4 (50.00%) 
Bone pain  1  4/7 (57.14%)  2/6 (33.33%)  0/1 (0.00%)  7/12 (58.33%)  7/9 (77.78%)  0/1 (0.00%)  0/4 (0.00%) 
Joint swelling  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Kyphosis  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Muscle spasms  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Musculoskeletal chest pain  1  0/7 (0.00%)  2/6 (33.33%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Musculoskeletal discomfort  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Musculoskeletal pain  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Pain in extremity  1  1/7 (14.29%)  0/6 (0.00%)  1/1 (100.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Nervous system disorders               
Dizziness  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  3/9 (33.33%)  0/1 (0.00%)  0/4 (0.00%) 
Headache  1  5/7 (71.43%)  0/6 (0.00%)  1/1 (100.00%)  2/12 (16.67%)  3/9 (33.33%)  1/1 (100.00%)  0/4 (0.00%) 
Hypoaesthesia  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Paraesthesia  1  3/7 (42.86%)  2/6 (33.33%)  1/1 (100.00%)  3/12 (25.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Sensory loss  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Syncope  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Psychiatric disorders               
Anxiety  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Insomnia  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  3/9 (33.33%)  0/1 (0.00%)  0/4 (0.00%) 
Nightmare  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders               
Nocturia  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Pollakiuria  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders               
Genital lesion  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Dyspnoea  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Pharyngolaryngeal pain  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Rhinorrhoea  1  0/7 (0.00%)  0/6 (0.00%)  1/1 (100.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Sinus congestion  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Sneezing  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Wheezing  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders               
Cold sweat  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Ecchymosis  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Hyperhidrosis  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/1 (0.00%)  0/4 (0.00%) 
Periorbital oedema  1  0/7 (0.00%)  0/6 (0.00%)  0/1 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Rash  1  1/7 (14.29%)  0/6 (0.00%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Vascular disorders               
Hypotension  1  0/7 (0.00%)  1/6 (16.67%)  0/1 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
The number and complexity of the cohorts make generalizations regarding the data problematic. Each cohort was small, and mobilizing and high-dose conditioning regimens varied across sites. AEs may include residual effects of chemotherapy.
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.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00322387     History of Changes
Other Study ID Numbers: AMD3100-2104
First Submitted: May 4, 2006
First Posted: May 5, 2006
Results First Submitted: June 15, 2010
Results First Posted: July 14, 2010
Last Update Posted: March 13, 2014