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Trial record 2 of 2 for:    NCT00103610

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00103610
Recruitment Status : Completed
First Posted : February 14, 2005
Results First Posted : September 29, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lymphoma, Non-Hodgkin
Interventions Drug: Granulocyte colony-stimulating factor plus plerixafor
Drug: Granulocyte colony-stimulating factor plus placebo
Enrollment 298
Recruitment Details Participants with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplant were recruited from 31 centers in the U.S. and 1 in Canada. The first participant was randomized on 18 January 2005 and the last participant’s last study visit occurred on 20 December 2007. A total of 298 participants were randomized.
Pre-assignment Details  
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Period Title: Overall Study
Started 150 148
Completed 112 68
Not Completed 38 80
Reason Not Completed
Entered Rescue Procedure             10             52
Death             16             12
Elective Withdrawal             4             0
Lost to Follow-up             3             1
Adverse Event             2             2
Other             2             7
Failed mobilization             1             5
Noncompliance             0             1
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo Total
Hide Arm/Group Description Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Total of all reporting groups
Overall Number of Baseline Participants 150 148 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 148 participants 298 participants
55.1  (10.9) 57.5  (10.3) 56.3  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 148 participants 298 participants
Female
50
  33.3%
46
  31.1%
96
  32.2%
Male
100
  66.7%
102
  68.9%
202
  67.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 150 participants 148 participants 298 participants
Caucasian 136 140 276
African-American 6 1 7
Asian 2 2 4
Hispanic/Latino 5 4 9
Other 1 1 2
1.Primary Outcome
Title Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
Hide Description Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Time Frame Days 5 to 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 150 148
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving target in ≤4 days 0.593 0.196
Proportion not achieving target in ≤4 days 0.407 0.804
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.
Time Frame up to Day 38
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 150 145
Measure Type: Number
Unit of Measure: participants
Adverse Events (AEs) 146 138
Related AEs 98 60
AEs Leading to early treatment termination 3 3
AEs Leading to early study termination 2 4
Grade 3 (severe) or 4 (life-threatening) AEs 11 14
SAEs 8 10
3.Secondary Outcome
Title Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
Hide Description Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Time Frame up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 150 148
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving target in ≤4 days 0.867 0.473
Proportion not achieving target in ≤4 days 0.133 0.527
4.Secondary Outcome
Title Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
Hide Description The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.
Time Frame up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population.
Arm/Group Title G-CSF + Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 147 142
Median (Inter-Quartile Range)
Unit of Measure: Days
3.0 [1] 
(1.0 to NA)
NA [2] 
(NA to NA)
[1]
Not enough participants reached the threshold to support estimating the upper range.
[2]
Not enough participants reached the threshold to estimate the values.
5.Secondary Outcome
Title Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Hide Description The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Time Frame Up to Month 13
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell transplant.
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 135 82
Median (Inter-Quartile Range)
Unit of Measure: Days
10.0
(10.0 to 11.0)
10.0
(10.0 to 11.0)
6.Secondary Outcome
Title Median Number of Days to Platelet (PLT) Engraftment
Hide Description The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.
Time Frame Up to Month 13
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell transplant
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 135 82
Median (Inter-Quartile Range)
Unit of Measure: Days
20.0
(17.0 to 25.0)
20.0
(18.0 to 25.0)
7.Secondary Outcome
Title Graft Durability at 100 Days Post Transplantation
Hide Description The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
Time Frame approximately Day 138
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell transplant and were evaluable at 100 days post-transplant
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 135 82
Measure Type: Number
Unit of Measure: proportion of participants
Proportion of participants with durable graft 0.948 0.951
Proportion of participants without durable graft 0.052 0.049
8.Secondary Outcome
Title Graft Durability at 6 Months Post Transplantation
Hide Description The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
Time Frame approximately Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell transplant and were evaluable at 6 months post-transplant
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 123 78
Measure Type: Number
Unit of Measure: proportion of participants
Proportion of participants with a durable graft 0.976 0.987
Proportion of participants without a durable graft 0.024 0.013
9.Secondary Outcome
Title Graft Durability at 12 Months Post Transplantation
Hide Description The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
Time Frame approximately Month 13
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell transplant and were evaluable at 12 months post-transplant
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description:
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 112 65
Measure Type: Number
Unit of Measure: proportion of participants
Proportion of participants with a durable graft 0.982 1.0
Proportion of participants without a durable graft 0.018 0.0
Time Frame Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
Adverse Event Reporting Description

Three participants did not receive any study treatment and were excluded from the safety analyses.

In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.

 
Arm/Group Title G-CSF Plus Plerixafor G-CSF Plus Placebo
Hide Arm/Group Description Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All-Cause Mortality
G-CSF Plus Plerixafor G-CSF Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
G-CSF Plus Plerixafor G-CSF Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/150 (5.33%)   10/145 (6.90%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/150 (0.67%)  0/145 (0.00%) 
Thrombocytopenia  1  1/150 (0.67%)  0/145 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/150 (0.00%)  2/145 (1.38%) 
Gastrointestinal disorders     
Abdominal pain lower  1  0/150 (0.00%)  1/145 (0.69%) 
General disorders     
Non-cardiac chest pain  1  0/150 (0.00%)  1/145 (0.69%) 
Pyrexia  1  1/150 (0.67%)  0/145 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/150 (0.00%)  1/145 (0.69%) 
Bacterial sepsis  1  0/150 (0.00%)  1/145 (0.69%) 
Catheter bacteraemia  1  1/150 (0.67%)  0/145 (0.00%) 
Pseudomonal sepsis  1  0/150 (0.00%)  1/145 (0.69%) 
Sinusitis  1  0/150 (0.00%)  1/145 (0.69%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/150 (0.67%)  0/145 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system  1  0/150 (0.00%)  1/145 (0.69%) 
Metastases to skin  1 [1]  1/150 (0.67%)  0/145 (0.00%) 
Nervous system disorders     
Convulsion  1  1/150 (0.67%)  0/145 (0.00%) 
Dizziness  1  1/150 (0.67%)  0/145 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  0/150 (0.00%)  1/145 (0.69%) 
Vascular disorders     
Hypotension  1  1/150 (0.67%)  0/145 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
A coding error occurred in coding changes from MedDRA version 6.1 to 10.0. An infectious AE coded with the preferred term bacteraemia (MedDRA version 6.1) is now coded as metastases to skin (MedDRA version 10.0).
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
G-CSF Plus Plerixafor G-CSF Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   145/150 (96.67%)   136/145 (93.79%) 
Blood and lymphatic system disorders     
Anaemia  1  3/150 (2.00%)  5/145 (3.45%) 
Lymphadenopathy  1  1/150 (0.67%)  2/145 (1.38%) 
Thrombocytopenia  1  5/150 (3.33%)  5/145 (3.45%) 
Cardiac disorders     
Angina pectoris  1  0/150 (0.00%)  1/145 (0.69%) 
Arrhythmia  1  0/150 (0.00%)  1/145 (0.69%) 
Atrial fibrillation  1  1/150 (0.67%)  1/145 (0.69%) 
Extrasystoles  1  2/150 (1.33%)  0/145 (0.00%) 
Palpitations  1  2/150 (1.33%)  3/145 (2.07%) 
Supraventricular tachycardia  1  1/150 (0.67%)  0/145 (0.00%) 
Tachycardia  1  5/150 (3.33%)  4/145 (2.76%) 
Ventricular extrasystoles  1  1/150 (0.67%)  0/145 (0.00%) 
Ventricular tachyarrhythmia  1  0/150 (0.00%)  1/145 (0.69%) 
Ear and labyrinth disorders     
Tinnitus  1  1/150 (0.67%)  3/145 (2.07%) 
Vertigo  1  3/150 (2.00%)  0/145 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  1/150 (0.67%)  0/145 (0.00%) 
Eye disorders     
Eye swelling  1  1/150 (0.67%)  0/145 (0.00%) 
Vision blurred  1  1/150 (0.67%)  1/145 (0.69%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/150 (1.33%)  1/145 (0.69%) 
Abdominal distension  1  9/150 (6.00%)  3/145 (2.07%) 
Abdominal pain  1  10/150 (6.67%)  4/145 (2.76%) 
Abdominal pain upper  1  4/150 (2.67%)  0/145 (0.00%) 
Constipation  1  2/150 (1.33%)  3/145 (2.07%) 
Diarrhoea  1  65/150 (43.33%)  20/145 (13.79%) 
Diarrhoea haemorrhagic  1  0/150 (0.00%)  1/145 (0.69%) 
Dry mouth  1  5/150 (3.33%)  4/145 (2.76%) 
Dyspepsia  1  4/150 (2.67%)  0/145 (0.00%) 
Dysphagia  1  1/150 (0.67%)  0/145 (0.00%) 
Eructation  1  1/150 (0.67%)  0/145 (0.00%) 
Flatulence  1  11/150 (7.33%)  7/145 (4.83%) 
Frequent bowel movements  1  5/150 (3.33%)  6/145 (4.14%) 
Glossodynia  1  0/150 (0.00%)  1/145 (0.69%) 
Haematochezia  1  1/150 (0.67%)  0/145 (0.00%) 
Haemorrhoidal haemorrhage  1  0/150 (0.00%)  1/145 (0.69%) 
Haemorrhoids  1  0/150 (0.00%)  1/145 (0.69%) 
Hypoaesthesia oral  1  4/150 (2.67%)  0/145 (0.00%) 
Inflammatory bowel disease  1  0/150 (0.00%)  1/145 (0.69%) 
Nausea  1  50/150 (33.33%)  24/145 (16.55%) 
Oral mucosal blistering  1  1/150 (0.67%)  0/145 (0.00%) 
Oral mucosal petechiae  1  0/150 (0.00%)  1/145 (0.69%) 
Paraesthesia oral  1  11/150 (7.33%)  13/145 (8.97%) 
Periodontitis  1  1/150 (0.67%)  0/145 (0.00%) 
Proctalgia  1  0/150 (0.00%)  1/145 (0.69%) 
Rectal haemorrhage  1  1/150 (0.67%)  1/145 (0.69%) 
Retching  1  2/150 (1.33%)  0/145 (0.00%) 
Salivary hypersecretion  1  1/150 (0.67%)  0/145 (0.00%) 
Stomach discomfort  1  4/150 (2.67%)  0/145 (0.00%) 
Tooth disorder  1  1/150 (0.67%)  0/145 (0.00%) 
Vomiting  1  12/150 (8.00%)  8/145 (5.52%) 
General disorders     
Asthenia  1  0/150 (0.00%)  2/145 (1.38%) 
Catheter related complication  1  1/150 (0.67%)  0/145 (0.00%) 
Catheter site discharge  1  2/150 (1.33%)  3/145 (2.07%) 
Catheter site erythema  1  3/150 (2.00%)  8/145 (5.52%) 
Catheter site haematoma  1  2/150 (1.33%)  1/145 (0.69%) 
Catheter site haemorrhage  1  6/150 (4.00%)  7/145 (4.83%) 
Catheter site oedema  1  0/150 (0.00%)  3/145 (2.07%) 
Catheter site pain  1  18/150 (12.00%)  21/145 (14.48%) 
Catheter site pruritus  1  2/150 (1.33%)  3/145 (2.07%) 
Catheter site rash  1  2/150 (1.33%)  2/145 (1.38%) 
Catheter site related reaction  1  2/150 (1.33%)  4/145 (2.76%) 
Chest discomfort  1  1/150 (0.67%)  2/145 (1.38%) 
Chest pain  1  0/150 (0.00%)  2/145 (1.38%) 
Chills  1  3/150 (2.00%)  6/145 (4.14%) 
Fatigue  1  40/150 (26.67%)  33/145 (22.76%) 
Feeling abnormal  1  1/150 (0.67%)  0/145 (0.00%) 
Feeling cold  1  2/150 (1.33%)  0/145 (0.00%) 
Feeling hot  1  0/150 (0.00%)  2/145 (1.38%) 
Immediate post-injection reaction  1  0/150 (0.00%)  1/145 (0.69%) 
Influenza like illness  1  2/150 (1.33%)  2/145 (1.38%) 
Injection site bruising  1  1/150 (0.67%)  3/145 (2.07%) 
Injection site discomfort  1  1/150 (0.67%)  0/145 (0.00%) 
Injection site erythema  1  48/150 (32.00%)  10/145 (6.90%) 
Injection site haematoma  1  1/150 (0.67%)  0/145 (0.00%) 
Injection site haemorrhage  1  1/150 (0.67%)  3/145 (2.07%) 
Injection site irritation  1  7/150 (4.67%)  0/145 (0.00%) 
Injection site pain  1  3/150 (2.00%)  4/145 (2.76%) 
Injection site pruritus  1  12/150 (8.00%)  1/145 (0.69%) 
Injection site rash  1  1/150 (0.67%)  1/145 (0.69%) 
Injection site reaction  1  3/150 (2.00%)  2/145 (1.38%) 
Injection site swelling  1  2/150 (1.33%)  0/145 (0.00%) 
Injection site urticaria  1  4/150 (2.67%)  0/145 (0.00%) 
Local swelling  1  1/150 (0.67%)  0/145 (0.00%) 
Localised oedema  1  0/150 (0.00%)  1/145 (0.69%) 
Malaise  1  1/150 (0.67%)  0/145 (0.00%) 
Mucosal inflammation  1  1/150 (0.67%)  0/145 (0.00%) 
Non-cardiac chest pain  1  2/150 (1.33%)  3/145 (2.07%) 
Oedema  1  1/150 (0.67%)  0/145 (0.00%) 
Oedema peripheral  1  16/150 (10.67%)  18/145 (12.41%) 
Pain  1  12/150 (8.00%)  15/145 (10.34%) 
Peripheral coldness  1  2/150 (1.33%)  0/145 (0.00%) 
Pyrexia  1  9/150 (6.00%)  8/145 (5.52%) 
Sensation of pressure  1  1/150 (0.67%)  0/145 (0.00%) 
Submandibular mass  1  0/150 (0.00%)  1/145 (0.69%) 
Infections and infestations     
Bacteraemia  1  1/150 (0.67%)  0/145 (0.00%) 
Body tinea  1  0/150 (0.00%)  1/145 (0.69%) 
Bronchitis  1  0/150 (0.00%)  1/145 (0.69%) 
Candidiasis  1  1/150 (0.67%)  0/145 (0.00%) 
Catheter bacteraemia  1  0/150 (0.00%)  1/145 (0.69%) 
Cellulitis  1  0/150 (0.00%)  1/145 (0.69%) 
Central line infection  1  3/150 (2.00%)  1/145 (0.69%) 
Erythema induratum  1  1/150 (0.67%)  1/145 (0.69%) 
Folliculitis  1  1/150 (0.67%)  0/145 (0.00%) 
Herpes zoster  1  1/150 (0.67%)  0/145 (0.00%) 
Nasopharyngitis  1  0/150 (0.00%)  3/145 (2.07%) 
Oral candidiasis  1  1/150 (0.67%)  1/145 (0.69%) 
Oral herpes  1  0/150 (0.00%)  1/145 (0.69%) 
Periodontal infection  1  0/150 (0.00%)  1/145 (0.69%) 
Rectal abscess  1  0/150 (0.00%)  1/145 (0.69%) 
Rhinitis  1  0/150 (0.00%)  1/145 (0.69%) 
Sinusitis  1  2/150 (1.33%)  0/145 (0.00%) 
Upper respiratory tract infection  1  3/150 (2.00%)  3/145 (2.07%) 
Urinary tract infection  1  1/150 (0.67%)  0/145 (0.00%) 
Viral upper respiratory tract infection  1  1/150 (0.67%)  0/145 (0.00%) 
Injury, poisoning and procedural complications     
Citrate toxicity  1  3/150 (2.00%)  2/145 (1.38%) 
Contusion  1  5/150 (3.33%)  4/145 (2.76%) 
Excoriation  1  1/150 (0.67%)  0/145 (0.00%) 
Limb injury  1  0/150 (0.00%)  1/145 (0.69%) 
Procedural pain  1  1/150 (0.67%)  2/145 (1.38%) 
Road traffic accident  1  1/150 (0.67%)  0/145 (0.00%) 
Skin laceration  1  1/150 (0.67%)  0/145 (0.00%) 
Subcutaneous haematoma  1  1/150 (0.67%)  0/145 (0.00%) 
Transfusion reaction  1  0/150 (0.00%)  1/145 (0.69%) 
Investigations     
Blood alkaline phosphatase increased  1  2/150 (1.33%)  3/145 (2.07%) 
Blood creatinine increased  1  1/150 (0.67%)  0/145 (0.00%) 
Blood magnesium decreased  1  1/150 (0.67%)  0/145 (0.00%) 
Blood potassium decreased  1  1/150 (0.67%)  0/145 (0.00%) 
Blood pressure decreased  1  0/150 (0.00%)  1/145 (0.69%) 
Blood pressure increased  1  0/150 (0.00%)  1/145 (0.69%) 
Blood uric acid increased  1  2/150 (1.33%)  8/145 (5.52%) 
Body temperature increased  1  0/150 (0.00%)  2/145 (1.38%) 
Breath sounds abnormal  1  2/150 (1.33%)  0/145 (0.00%) 
Electrocardiogram T wave inversion  1  0/150 (0.00%)  1/145 (0.69%) 
Hepatic enzyme increased  1  0/150 (0.00%)  1/145 (0.69%) 
Platelet count decreased  1  1/150 (0.67%)  3/145 (2.07%) 
Urine analysis abnormal  1  1/150 (0.67%)  0/145 (0.00%) 
Weight increased  1  2/150 (1.33%)  1/145 (0.69%) 
Metabolism and nutrition disorders     
Anorexia  1  1/150 (0.67%)  3/145 (2.07%) 
Decreased appetite  1  2/150 (1.33%)  1/145 (0.69%) 
Dehydration  1  0/150 (0.00%)  1/145 (0.69%) 
Fluid overload  1  1/150 (0.67%)  1/145 (0.69%) 
Gout  1  2/150 (1.33%)  0/145 (0.00%) 
Hyperglycaemia  1  1/150 (0.67%)  0/145 (0.00%) 
Hyperuricaemia  1  3/150 (2.00%)  4/145 (2.76%) 
Hypocalcaemia  1  4/150 (2.67%)  3/145 (2.07%) 
Hypoglycaemia  1  1/150 (0.67%)  0/145 (0.00%) 
Hypokalaemia  1  25/150 (16.67%)  20/145 (13.79%) 
Hypomagnesaemia  1  17/150 (11.33%)  12/145 (8.28%) 
Hypophosphataemia  1  2/150 (1.33%)  0/145 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  23/150 (15.33%)  19/145 (13.10%) 
Back pain  1  31/150 (20.67%)  30/145 (20.69%) 
Bone pain  1  40/150 (26.67%)  41/145 (28.28%) 
Joint stiffness  1  0/150 (0.00%)  1/145 (0.69%) 
Limb discomfort  1  1/150 (0.67%)  0/145 (0.00%) 
Muscle spasms  1  7/150 (4.67%)  6/145 (4.14%) 
Muscle twitching  1  0/150 (0.00%)  1/145 (0.69%) 
Muscular weakness  1  2/150 (1.33%)  1/145 (0.69%) 
Musculoskeletal chest pain  1  1/150 (0.67%)  5/145 (3.45%) 
Musculoskeletal discomfort  1  2/150 (1.33%)  0/145 (0.00%) 
Musculoskeletal pain  1  3/150 (2.00%)  4/145 (2.76%) 
Musculoskeletal stiffness  1  2/150 (1.33%)  0/145 (0.00%) 
Myalgia  1  3/150 (2.00%)  7/145 (4.83%) 
Neck pain  1  3/150 (2.00%)  5/145 (3.45%) 
Osteoarthritis  1  0/150 (0.00%)  1/145 (0.69%) 
Pain in extremity  1  7/150 (4.67%)  10/145 (6.90%) 
Pain in jaw  1  0/150 (0.00%)  1/145 (0.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system  1  0/150 (0.00%)  1/145 (0.69%) 
Non-Hodgkin's lymphoma  1  0/150 (0.00%)  1/145 (0.69%) 
Nervous system disorders     
Amnesia  1  0/150 (0.00%)  1/145 (0.69%) 
Areflexia  1  1/150 (0.67%)  0/145 (0.00%) 
Balance disorder  1  1/150 (0.67%)  0/145 (0.00%) 
Convulsion  1  1/150 (0.67%)  0/145 (0.00%) 
Dizziness  1  13/150 (8.67%)  8/145 (5.52%) 
Dizziness postural  1  0/150 (0.00%)  1/145 (0.69%) 
Dysgeusia  1  2/150 (1.33%)  1/145 (0.69%) 
Headache  1  37/150 (24.67%)  27/145 (18.62%) 
Hypoaesthesia  1  3/150 (2.00%)  6/145 (4.14%) 
Hypogeusia  1  0/150 (0.00%)  1/145 (0.69%) 
Neuropathy peripheral  1  1/150 (0.67%)  0/145 (0.00%) 
Nystagmus  1  0/150 (0.00%)  1/145 (0.69%) 
Paraesthesia  1  27/150 (18.00%)  30/145 (20.69%) 
Peripheral sensory neuropathy  1  1/150 (0.67%)  0/145 (0.00%) 
Poor quality sleep  1  0/150 (0.00%)  1/145 (0.69%) 
Sedation  1  1/150 (0.67%)  0/145 (0.00%) 
Sensory disturbance  1  0/150 (0.00%)  1/145 (0.69%) 
Syncope  1  2/150 (1.33%)  0/145 (0.00%) 
Syncope vasovagal  1  1/150 (0.67%)  0/145 (0.00%) 
Tremor  1  2/150 (1.33%)  6/145 (4.14%) 
Psychiatric disorders     
Abnormal dreams  1  1/150 (0.67%)  0/145 (0.00%) 
Anxiety  1  7/150 (4.67%)  7/145 (4.83%) 
Confusional state  1  0/150 (0.00%)  1/145 (0.69%) 
Depression  1  2/150 (1.33%)  0/145 (0.00%) 
Hallucination  1  1/150 (0.67%)  0/145 (0.00%) 
Insomnia  1  11/150 (7.33%)  4/145 (2.76%) 
Nightmare  1  1/150 (0.67%)  0/145 (0.00%) 
Restlessness  1  0/150 (0.00%)  1/145 (0.69%) 
Sleep disorder  1  1/150 (0.67%)  0/145 (0.00%) 
Renal and urinary disorders     
Dysuria  1  3/150 (2.00%)  2/145 (1.38%) 
Haematuria  1  0/150 (0.00%)  1/145 (0.69%) 
Pollakiuria  1  1/150 (0.67%)  1/145 (0.69%) 
Urine odour abnormal  1  1/150 (0.67%)  0/145 (0.00%) 
Reproductive system and breast disorders     
Breast swelling  1  1/150 (0.67%)  0/145 (0.00%) 
Testicular pain  1  1/150 (0.67%)  0/145 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/150 (4.67%)  4/145 (2.76%) 
Dyspnoea  1  6/150 (4.00%)  5/145 (3.45%) 
Dyspnoea exertional  1  2/150 (1.33%)  1/145 (0.69%) 
Haemoptysis  1  0/150 (0.00%)  1/145 (0.69%) 
Nasal congestion  1  2/150 (1.33%)  2/145 (1.38%) 
Nasal dryness  1  1/150 (0.67%)  0/145 (0.00%) 
Obstructive airways disorder  1  1/150 (0.67%)  0/145 (0.00%) 
Paranasal sinus hypersecretion  1  2/150 (1.33%)  0/145 (0.00%) 
Pharyngolaryngeal pain  1  2/150 (1.33%)  2/145 (1.38%) 
Pleural effusion  1  0/150 (0.00%)  1/145 (0.69%) 
Rales  1  0/150 (0.00%)  1/145 (0.69%) 
Rhinorrhoea  1  5/150 (3.33%)  2/145 (1.38%) 
Sinus congestion  1  0/150 (0.00%)  1/145 (0.69%) 
Sneezing  1  0/150 (0.00%)  1/145 (0.69%) 
Throat irritation  1  1/150 (0.67%)  0/145 (0.00%) 
Upper respiratory tract congestion  1  0/150 (0.00%)  2/145 (1.38%) 
Wheezing  1  1/150 (0.67%)  0/145 (0.00%) 
Skin and subcutaneous tissue disorders     
Blister  1  1/150 (0.67%)  0/145 (0.00%) 
Dermatitis  1  0/150 (0.00%)  1/145 (0.69%) 
Dermatitis contact  1  1/150 (0.67%)  0/145 (0.00%) 
Ecchymosis  1  1/150 (0.67%)  0/145 (0.00%) 
Erythema  1  5/150 (3.33%)  2/145 (1.38%) 
Hyperhidrosis  1  8/150 (5.33%)  3/145 (2.07%) 
Hypoaesthesia facial  1  1/150 (0.67%)  1/145 (0.69%) 
Night sweats  1  10/150 (6.67%)  4/145 (2.76%) 
Pruritus  1  1/150 (0.67%)  3/145 (2.07%) 
Pruritus generalised  1  0/150 (0.00%)  1/145 (0.69%) 
Rash  1  6/150 (4.00%)  8/145 (5.52%) 
Rash generalised  1  0/150 (0.00%)  1/145 (0.69%) 
Rash pruritic  1  0/150 (0.00%)  1/145 (0.69%) 
Skin irritation  1  1/150 (0.67%)  0/145 (0.00%) 
Skin lesion  1  0/150 (0.00%)  1/145 (0.69%) 
Urticaria  1  1/150 (0.67%)  0/145 (0.00%) 
Urticaria localised  1  1/150 (0.67%)  0/145 (0.00%) 
Vascular disorders     
Flushing  1  8/150 (5.33%)  5/145 (3.45%) 
Haematoma  1  1/150 (0.67%)  0/145 (0.00%) 
Hot flush  1  3/150 (2.00%)  2/145 (1.38%) 
Hypertension  1  1/150 (0.67%)  3/145 (2.07%) 
Hypotension  1  8/150 (5.33%)  2/145 (1.38%) 
Pallor  1  1/150 (0.67%)  1/145 (0.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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
Layout table for Results Point of Contact information
Name/Title: Genzyme MedInfo
Organization: Genzyme Corporation
EMail: medinfo@genzyme.com
Layout table for additonal information
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00103610    
Obsolete Identifiers: NCT00248508
Other Study ID Numbers: AMD3100-3101
First Submitted: February 11, 2005
First Posted: February 14, 2005
Results First Submitted: February 6, 2009
Results First Posted: September 29, 2010
Last Update Posted: March 13, 2014