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Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT00103662
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 Multiple Myeloma
Interventions Drug: Granulocyte colony-stimulating factor plus plerixafor
Drug: Granulocyte colony-stimulating factor plus placebo
Enrollment 302
Recruitment Details Participants with multiple myeloma (MM) eligible for autologous hematopoietic stem cell transplant were recruited from 40 centers (38 in the U.S., 1 in Germany, 1 in Canada). The first participant was randomized on 04 February 2005 and the last participant’s last study visit occurred on 22 January 2008. A total of 302 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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Period Title: Overall Study
Started 148 154
Completed 129 [1] 121 [1]
Not Completed 19 33
Reason Not Completed
Entered Rescue Procedure             0             7
Death             7             7
Elective Withdrawal             5             5
Lost to Follow-up             0             1
Other             6             9
Failed mobilization             0             4
Intercurrent illness             1             0
[1]
1 participant was wrongly terminated due to 'other'; the participant stayed on study until death.
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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected. Total of all reporting groups
Overall Number of Baseline Participants 148 154 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 154 participants 302 participants
58.2  (8.4) 58.4  (8.6) 58.3  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 154 participants 302 participants
Female
48
  32.4%
47
  30.5%
95
  31.5%
Male
100
  67.6%
107
  69.5%
207
  68.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants 154 participants 302 participants
Caucasian 117 128 245
African-American 18 14 32
Asian 1 3 4
Hispanic/Latino 11 4 15
Other 1 5 6
1.Primary Outcome
Title Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Hide Description Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
Time Frame up to Day 6
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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 148 154
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving target in ≤2 days 0.716 0.344
Proportion not achieving target in ≤2 days 0.284 0.656
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
Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four 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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 147 151
Measure Type: Number
Unit of Measure: participants
Adverse Events (AEs) 140 140
Related AEs 95 67
AEs Leading to early treatment termination 1 2
AEs Leading to early termination 3 0
Grade 3 (severe) or 4 (life-threatening) AEs 11 11
Serious Adverse Events (SAEs) 4 6
3.Secondary Outcome
Title Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Hide Description Proportion of participants achieving a target of ≥ 6*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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 148 154
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving target in ≤4 days 0.757 0.513
Proportion not achieving target in ≤4 days 0.243 0.487
4.Secondary Outcome
Title Proportion of Participants Achieving a Target of ≥ 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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 148 154
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving target in ≤4 days 0.953 0.883
Proportion not achieving target in ≤4 days 0.047 0.117
5.Secondary Outcome
Title Median Number of Days to ≥6*10^6 CD34+ Cells/kg
Hide Description The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.
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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 144 150
Median (Inter-Quartile Range)
Unit of Measure: Days
1.0
(1.0 to 2.0)
4.0 [1] 
(2.0 to NA)
[1]
Not enough participants reached the threshold to support estimating the upper range.
6.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 and was evaluated up to 12 months post transplant.
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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 142 136
Median (Inter-Quartile Range)
Unit of Measure: Days
11.0
(10.0 to 12.0)
11.0
(11.0 to 12.0)
7.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 and was evaluated up to 12 months post transplant.
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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 142 136
Median (Inter-Quartile Range)
Unit of Measure: Days
18.0
(16.0 to 22.0)
18.0
(16.0 to 21.0)
8.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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 142 136
Measure Type: Number
Unit of Measure: proportion of participants
Proportion of participants with a durable graft 0.986 0.978
Proportion of participants without a durable graft 0.014 0.022
9.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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 135 127
Measure Type: Number
Unit of Measure: proportion of participants
Proportion of participants with a durable graft 0.985 0.984
Proportion of participants without a durable graft 0.015 0.016
10.Secondary Outcome
Title Graft Durability at 12 Months Post Transplantation
Hide Description The proportion of participants maintaining a durable graft at 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 ≥ 6*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 ≥ 6*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 128 120
Measure Type: Number
Unit of Measure: proportion of participants
Proportion of participants with a durable graft 0.992 0.992
Proportion of participants without a durable graft 0.008 0.008
Time Frame Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8).
Adverse Event Reporting Description

Four 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 ≥ 6*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 ≥ 6*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   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
G-CSF Plus Plerixafor G-CSF Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/147 (2.72%)   6/151 (3.97%) 
Cardiac disorders     
Atrial fibrillation  1  1/147 (0.68%)  0/151 (0.00%) 
Gastrointestinal disorders     
Nausea  1  0/147 (0.00%)  2/151 (1.32%) 
Vomiting  1  0/147 (0.00%)  1/151 (0.66%) 
Infections and infestations     
Enterobacter bacteraemia  1  0/147 (0.00%)  1/151 (0.66%) 
Metabolism and nutrition disorders     
Dehydration  1  0/147 (0.00%)  1/151 (0.66%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/147 (0.68%)  1/151 (0.66%) 
Nervous system disorders     
Hemiparesis  1  1/147 (0.68%)  0/151 (0.00%) 
Muscle spasticity  1  0/147 (0.00%)  1/151 (0.66%) 
Psychiatric disorders     
Agitation  1  0/147 (0.00%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  0/147 (0.00%)  1/151 (0.66%) 
Vascular disorders     
Deep vein thrombosis  1  1/147 (0.68%)  0/151 (0.00%) 
Jugular vein thrombosis  1  0/147 (0.00%)  1/151 (0.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events 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   140/147 (95.24%)   140/151 (92.72%) 
Blood and lymphatic system disorders     
Anaemia  1  2/147 (1.36%)  4/151 (2.65%) 
Lymphadenopathy  1  1/147 (0.68%)  0/151 (0.00%) 
Lymphopenia  1  1/147 (0.68%)  1/151 (0.66%) 
Splenomegaly  1  0/147 (0.00%)  1/151 (0.66%) 
Thrombocytopenia  1  2/147 (1.36%)  4/151 (2.65%) 
Cardiac disorders     
Angina pectoris  1  0/147 (0.00%)  1/151 (0.66%) 
Arrhythmia  1  0/147 (0.00%)  1/151 (0.66%) 
Atrioventricular block first degree  1  1/147 (0.68%)  0/151 (0.00%) 
Extrasystoles  1  0/147 (0.00%)  1/151 (0.66%) 
Myocardial ischaemia  1  0/147 (0.00%)  1/151 (0.66%) 
Palpitations  1  2/147 (1.36%)  4/151 (2.65%) 
Sinus tachycardia  1  1/147 (0.68%)  1/151 (0.66%) 
Supraventricular tachycardia  1  0/147 (0.00%)  1/151 (0.66%) 
Tachycardia  1  2/147 (1.36%)  4/151 (2.65%) 
Ventricular extrasystoles  1  1/147 (0.68%)  0/151 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/147 (0.68%)  0/151 (0.00%) 
Ear and labyrinth disorders     
Deafness  1  1/147 (0.68%)  0/151 (0.00%) 
Ear pain  1  0/147 (0.00%)  2/151 (1.32%) 
Tinnitus  1  1/147 (0.68%)  0/151 (0.00%) 
Eye disorders     
Eye irritation  1  0/147 (0.00%)  1/151 (0.66%) 
Eye pruritus  1  0/147 (0.00%)  1/151 (0.66%) 
Ocular hyperaemia  1  1/147 (0.68%)  0/151 (0.00%) 
Vision blurred  1  3/147 (2.04%)  0/151 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  3/147 (2.04%)  5/151 (3.31%) 
Abdominal mass  1  0/147 (0.00%)  1/151 (0.66%) 
Abdominal pain  1  3/147 (2.04%)  3/151 (1.99%) 
Abdominal pain upper  1  0/147 (0.00%)  4/151 (2.65%) 
Constipation  1  9/147 (6.12%)  5/151 (3.31%) 
Dental discomfort  1  1/147 (0.68%)  0/151 (0.00%) 
Diarrhoea  1  47/147 (31.97%)  29/151 (19.21%) 
Dry mouth  1  6/147 (4.08%)  6/151 (3.97%) 
Duodenogastric reflux  1  0/147 (0.00%)  1/151 (0.66%) 
Dyspepsia  1  2/147 (1.36%)  1/151 (0.66%) 
Dysphagia  1  2/147 (1.36%)  1/151 (0.66%) 
Eructation  1  1/147 (0.68%)  0/151 (0.00%) 
Faeces discoloured  1  1/147 (0.68%)  0/151 (0.00%) 
Flatulence  1  9/147 (6.12%)  4/151 (2.65%) 
Frequent bowel movements  1  6/147 (4.08%)  5/151 (3.31%) 
Gastritis  1  0/147 (0.00%)  1/151 (0.66%) 
Gastrooesophageal reflux disease  1  0/147 (0.00%)  1/151 (0.66%) 
Haemorrhoids  1  0/147 (0.00%)  1/151 (0.66%) 
Hypoaesthesia oral  1  3/147 (2.04%)  1/151 (0.66%) 
Localised intraabdominal fluid collection  1  1/147 (0.68%)  1/151 (0.66%) 
Mouth ulceration  1  0/147 (0.00%)  1/151 (0.66%) 
Nausea  1  51/147 (34.69%)  39/151 (25.83%) 
Oral soft tissue disorder  1  0/147 (0.00%)  1/151 (0.66%) 
Paraesthesia oral  1  11/147 (7.48%)  13/151 (8.61%) 
Retching  1  1/147 (0.68%)  0/151 (0.00%) 
Stomach discomfort  1  2/147 (1.36%)  1/151 (0.66%) 
Stomatitis  1  3/147 (2.04%)  0/151 (0.00%) 
Tongue haematoma  1  1/147 (0.68%)  0/151 (0.00%) 
Toothache  1  1/147 (0.68%)  0/151 (0.00%) 
Vomiting  1  17/147 (11.56%)  9/151 (5.96%) 
General disorders     
Asthenia  1  5/147 (3.40%)  3/151 (1.99%) 
Catheter related complication  1  1/147 (0.68%)  5/151 (3.31%) 
Catheter site discharge  1  1/147 (0.68%)  1/151 (0.66%) 
Catheter site erythema  1  1/147 (0.68%)  4/151 (2.65%) 
Catheter site haematoma  1  2/147 (1.36%)  0/151 (0.00%) 
Catheter site haemorrhage  1  6/147 (4.08%)  6/151 (3.97%) 
Catheter site inflammation  1  1/147 (0.68%)  0/151 (0.00%) 
Catheter site oedema  1  0/147 (0.00%)  1/151 (0.66%) 
Catheter site pain  1  14/147 (9.52%)  19/151 (12.58%) 
Catheter site pruritus  1  1/147 (0.68%)  1/151 (0.66%) 
Catheter site related reaction  1  7/147 (4.76%)  4/151 (2.65%) 
Chest discomfort  1  3/147 (2.04%)  2/151 (1.32%) 
Chest pain  1  2/147 (1.36%)  2/151 (1.32%) 
Chills  1  4/147 (2.72%)  4/151 (2.65%) 
Discomfort  1  0/147 (0.00%)  1/151 (0.66%) 
Fatigue  1  40/147 (27.21%)  41/151 (27.15%) 
Feeling abnormal  1  0/147 (0.00%)  1/151 (0.66%) 
Feeling cold  1  2/147 (1.36%)  2/151 (1.32%) 
Feeling hot  1  0/147 (0.00%)  1/151 (0.66%) 
Gait disturbance  1  0/147 (0.00%)  1/151 (0.66%) 
Influenza like illness  1  3/147 (2.04%)  1/151 (0.66%) 
Infusion site mass  1  1/147 (0.68%)  0/151 (0.00%) 
Infusion site thrombosis  1  0/147 (0.00%)  1/151 (0.66%) 
Injection site bruising  1  3/147 (2.04%)  2/151 (1.32%) 
Injection site discharge  1  1/147 (0.68%)  0/151 (0.00%) 
Injection site erythema  1  32/147 (21.77%)  5/151 (3.31%) 
Injection site haemorrhage  1  4/147 (2.72%)  1/151 (0.66%) 
Injection site induration  1  1/147 (0.68%)  0/151 (0.00%) 
Injection site irritation  1  3/147 (2.04%)  3/151 (1.99%) 
Injection site pain  1  3/147 (2.04%)  1/151 (0.66%) 
Injection site paraesthesia  1  1/147 (0.68%)  0/151 (0.00%) 
Injection site pruritus  1  5/147 (3.40%)  1/151 (0.66%) 
Injection site rash  1  2/147 (1.36%)  0/151 (0.00%) 
Injection site reaction  1  1/147 (0.68%)  0/151 (0.00%) 
Injection site swelling  1  1/147 (0.68%)  1/151 (0.66%) 
Irritability  1  1/147 (0.68%)  0/151 (0.00%) 
Malaise  1  5/147 (3.40%)  1/151 (0.66%) 
Mucosal inflammation  1  0/147 (0.00%)  1/151 (0.66%) 
Non-cardiac chest pain  1  1/147 (0.68%)  0/151 (0.00%) 
Oedema peripheral  1  12/147 (8.16%)  10/151 (6.62%) 
Pain  1  11/147 (7.48%)  11/151 (7.28%) 
Peripheral coldness  1  0/147 (0.00%)  1/151 (0.66%) 
Pitting oedema  1  0/147 (0.00%)  1/151 (0.66%) 
Pyrexia  1  8/147 (5.44%)  11/151 (7.28%) 
Sensation of pressure  1  0/147 (0.00%)  1/151 (0.66%) 
Vessel puncture site haematoma  1  0/147 (0.00%)  1/151 (0.66%) 
Infections and infestations     
Bacteraemia  1  0/147 (0.00%)  1/151 (0.66%) 
Bronchopneumonia  1  1/147 (0.68%)  0/151 (0.00%) 
Bronchopulmonary aspergillosis  1  1/147 (0.68%)  0/151 (0.00%) 
Catheter site infection  1  0/147 (0.00%)  1/151 (0.66%) 
Herpes zoster  1  1/147 (0.68%)  0/151 (0.00%) 
Nasopharyngitis  1  2/147 (1.36%)  0/151 (0.00%) 
Oral candidiasis  1  1/147 (0.68%)  0/151 (0.00%) 
Pneumonia fungal  1  1/147 (0.68%)  0/151 (0.00%) 
Respiratory tract infection  1  0/147 (0.00%)  1/151 (0.66%) 
Rhinitis  1  1/147 (0.68%)  0/151 (0.00%) 
Sinusitis  1  1/147 (0.68%)  0/151 (0.00%) 
Tinea manuum  1  0/147 (0.00%)  1/151 (0.66%) 
Tinea pedis  1  1/147 (0.68%)  0/151 (0.00%) 
Tooth abscess  1  0/147 (0.00%)  1/151 (0.66%) 
Upper respiratory tract infection  1  3/147 (2.04%)  4/151 (2.65%) 
Urinary tract infection  1  0/147 (0.00%)  2/151 (1.32%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  1/147 (0.68%)  0/151 (0.00%) 
Citrate toxicity  1  6/147 (4.08%)  4/151 (2.65%) 
Contusion  1  4/147 (2.72%)  5/151 (3.31%) 
Post procedural discomfort  1  0/147 (0.00%)  1/151 (0.66%) 
Procedural hypertension  1  1/147 (0.68%)  0/151 (0.00%) 
Procedural nausea  1  1/147 (0.68%)  0/151 (0.00%) 
Procedural pain  1  1/147 (0.68%)  1/151 (0.66%) 
Skin laceration  1  0/147 (0.00%)  1/151 (0.66%) 
Tooth fracture  1  0/147 (0.00%)  1/151 (0.66%) 
Tooth injury  1  1/147 (0.68%)  0/151 (0.00%) 
Investigations     
Aspartate aminotransferase increased  1  1/147 (0.68%)  0/151 (0.00%) 
Blood alkaline phosphatase increased  1  3/147 (2.04%)  3/151 (1.99%) 
Blood calcium decreased  1  0/147 (0.00%)  1/151 (0.66%) 
Blood glucose decreased  1  0/147 (0.00%)  1/151 (0.66%) 
Blood magnesium decreased  1  1/147 (0.68%)  1/151 (0.66%) 
Blood potassium decreased  1  2/147 (1.36%)  1/151 (0.66%) 
Blood pressure increased  1  0/147 (0.00%)  1/151 (0.66%) 
Blood uric acid increased  1  6/147 (4.08%)  6/151 (3.97%) 
Body temperature increased  1  1/147 (0.68%)  0/151 (0.00%) 
C-reactive protein increased  1  1/147 (0.68%)  0/151 (0.00%) 
Cardiac murmur  1  1/147 (0.68%)  0/151 (0.00%) 
Culture positive  1  0/147 (0.00%)  1/151 (0.66%) 
Haemoglobin decreased  1  0/147 (0.00%)  1/151 (0.66%) 
Heart rate increased  1  0/147 (0.00%)  1/151 (0.66%) 
Heart rate irregular  1  1/147 (0.68%)  4/151 (2.65%) 
Lymph node palpable  1  1/147 (0.68%)  0/151 (0.00%) 
Oxygen saturation decreased  1  0/147 (0.00%)  2/151 (1.32%) 
Platelet count decreased  1  0/147 (0.00%)  1/151 (0.66%) 
Weight decreased  1  1/147 (0.68%)  0/151 (0.00%) 
Weight increased  1  1/147 (0.68%)  1/151 (0.66%) 
Metabolism and nutrition disorders     
Anorexia  1  6/147 (4.08%)  6/151 (3.97%) 
Decreased appetite  1  6/147 (4.08%)  5/151 (3.31%) 
Hyperuricaemia  1  0/147 (0.00%)  3/151 (1.99%) 
Hypocalcaemia  1  6/147 (4.08%)  6/151 (3.97%) 
Hypokalaemia  1  19/147 (12.93%)  29/151 (19.21%) 
Hypomagnesaemia  1  9/147 (6.12%)  16/151 (10.60%) 
Hyponatraemia  1  1/147 (0.68%)  0/151 (0.00%) 
Hypophosphataemia  1  0/147 (0.00%)  1/151 (0.66%) 
Tetany  1  1/147 (0.68%)  0/151 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  16/147 (10.88%)  17/151 (11.26%) 
Back pain  1  23/147 (15.65%)  34/151 (22.52%) 
Bone pain  1  53/147 (36.05%)  64/151 (42.38%) 
Flank pain  1  0/147 (0.00%)  1/151 (0.66%) 
Jaw disorder  1  0/147 (0.00%)  1/151 (0.66%) 
Joint swelling  1  1/147 (0.68%)  0/151 (0.00%) 
Muscle disorder  1  1/147 (0.68%)  0/151 (0.00%) 
Muscle spasms  1  5/147 (3.40%)  8/151 (5.30%) 
Muscle twitching  1  1/147 (0.68%)  0/151 (0.00%) 
Muscular weakness  1  1/147 (0.68%)  0/151 (0.00%) 
Musculoskeletal chest pain  1  8/147 (5.44%)  5/151 (3.31%) 
Musculoskeletal discomfort  1  0/147 (0.00%)  1/151 (0.66%) 
Musculoskeletal pain  1  7/147 (4.76%)  5/151 (3.31%) 
Musculoskeletal stiffness  1  3/147 (2.04%)  2/151 (1.32%) 
Myalgia  1  2/147 (1.36%)  0/151 (0.00%) 
Neck pain  1  5/147 (3.40%)  0/151 (0.00%) 
Pain in extremity  1  8/147 (5.44%)  11/151 (7.28%) 
Pain in jaw  1  1/147 (0.68%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bone neoplasm malignant  1  1/147 (0.68%)  0/151 (0.00%) 
Lentigo  1  0/147 (0.00%)  1/151 (0.66%) 
Prostate cancer  1  1/147 (0.68%)  0/151 (0.00%) 
Nervous system disorders     
Balance disorder  1  1/147 (0.68%)  1/151 (0.66%) 
Burning sensation  1  1/147 (0.68%)  0/151 (0.00%) 
Coordination abnormal  1  1/147 (0.68%)  0/151 (0.00%) 
Dizziness  1  17/147 (11.56%)  10/151 (6.62%) 
Dysgeusia  1  7/147 (4.76%)  2/151 (1.32%) 
Dyskinesia  1  0/147 (0.00%)  1/151 (0.66%) 
Headache  1  30/147 (20.41%)  35/151 (23.18%) 
Hypoaesthesia  1  8/147 (5.44%)  7/151 (4.64%) 
Lethargy  1  0/147 (0.00%)  1/151 (0.66%) 
Neuropathy peripheral  1  0/147 (0.00%)  1/151 (0.66%) 
Paraesthesia  1  33/147 (22.45%)  34/151 (22.52%) 
Parosmia  1  1/147 (0.68%)  0/151 (0.00%) 
Restless legs syndrome  1  2/147 (1.36%)  2/151 (1.32%) 
Sensory disturbance  1  1/147 (0.68%)  0/151 (0.00%) 
Sinus headache  1  0/147 (0.00%)  1/151 (0.66%) 
Somnolence  1  0/147 (0.00%)  1/151 (0.66%) 
Tremor  1  3/147 (2.04%)  3/151 (1.99%) 
Psychiatric disorders     
Abnormal dreams  1  0/147 (0.00%)  1/151 (0.66%) 
Anticipatory anxiety  1  1/147 (0.68%)  0/151 (0.00%) 
Anxiety  1  9/147 (6.12%)  6/151 (3.97%) 
Confusional state  1  1/147 (0.68%)  0/151 (0.00%) 
Depression  1  1/147 (0.68%)  1/151 (0.66%) 
Emotional distress  1  0/147 (0.00%)  1/151 (0.66%) 
Insomnia  1  10/147 (6.80%)  11/151 (7.28%) 
Restlessness  1  2/147 (1.36%)  0/151 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/147 (0.00%)  2/151 (1.32%) 
Nocturia  1  1/147 (0.68%)  0/151 (0.00%) 
Pollakiuria  1  2/147 (1.36%)  1/151 (0.66%) 
Proteinuria  1  1/147 (0.68%)  0/151 (0.00%) 
Reproductive system and breast disorders     
Pelvic pain  1  0/147 (0.00%)  1/151 (0.66%) 
Vaginal pain  1  0/147 (0.00%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/147 (0.68%)  3/151 (1.99%) 
Dyspnoea  1  3/147 (2.04%)  4/151 (2.65%) 
Dyspnoea exertional  1  2/147 (1.36%)  4/151 (2.65%) 
Nasal congestion  1  1/147 (0.68%)  0/151 (0.00%) 
Nasal mucosal disorder  1  1/147 (0.68%)  0/151 (0.00%) 
Paranasal sinus hypersecretion  1  0/147 (0.00%)  3/151 (1.99%) 
Pharyngolaryngeal pain  1  3/147 (2.04%)  6/151 (3.97%) 
Postnasal drip  1  1/147 (0.68%)  1/151 (0.66%) 
Productive cough  1  1/147 (0.68%)  1/151 (0.66%) 
Rhinorrhoea  1  1/147 (0.68%)  2/151 (1.32%) 
Rhonchi  1  1/147 (0.68%)  0/151 (0.00%) 
Sinus congestion  1  2/147 (1.36%)  0/151 (0.00%) 
Wheezing  1  0/147 (0.00%)  1/151 (0.66%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  1/147 (0.68%)  0/151 (0.00%) 
Alopecia  1  1/147 (0.68%)  0/151 (0.00%) 
Cold sweat  1  2/147 (1.36%)  0/151 (0.00%) 
Dermatitis contact  1  1/147 (0.68%)  1/151 (0.66%) 
Dry skin  1  1/147 (0.68%)  2/151 (1.32%) 
Ecchymosis  1  2/147 (1.36%)  2/151 (1.32%) 
Eczema  1  1/147 (0.68%)  0/151 (0.00%) 
Ephelides  1  1/147 (0.68%)  0/151 (0.00%) 
Erythema  1  3/147 (2.04%)  1/151 (0.66%) 
Erythema nodosum  1  0/147 (0.00%)  1/151 (0.66%) 
Hyperhidrosis  1  4/147 (2.72%)  5/151 (3.31%) 
Hypoaesthesia facial  1  5/147 (3.40%)  0/151 (0.00%) 
Ingrowing nail  1  0/147 (0.00%)  1/151 (0.66%) 
Night sweats  1  4/147 (2.72%)  2/151 (1.32%) 
Pruritus  1  4/147 (2.72%)  2/151 (1.32%) 
Rash  1  3/147 (2.04%)  2/151 (1.32%) 
Rash generalised  1  0/147 (0.00%)  1/151 (0.66%) 
Scar  1  0/147 (0.00%)  1/151 (0.66%) 
Skin irritation  1  4/147 (2.72%)  1/151 (0.66%) 
Skin lesion  1  0/147 (0.00%)  1/151 (0.66%) 
Vascular disorders     
Flushing  1  2/147 (1.36%)  1/151 (0.66%) 
Hot flush  1  2/147 (1.36%)  1/151 (0.66%) 
Hypertension  1  2/147 (1.36%)  5/151 (3.31%) 
Hypotension  1  2/147 (1.36%)  5/151 (3.31%) 
Orthostatic hypotension  1  1/147 (0.68%)  0/151 (0.00%) 
Pallor  1  0/147 (0.00%)  1/151 (0.66%) 
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 Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Layout table for additonal information
Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00103662     History of Changes
Obsolete Identifiers: NCT00248417
Other Study ID Numbers: AMD3100-3102
2005-003599-39 ( EudraCT Number )
First Submitted: February 11, 2005
First Posted: February 14, 2005
Results First Submitted: February 2, 2009
Results First Posted: September 29, 2010
Last Update Posted: March 13, 2014