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AMD3100 (Plerixafor) Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF

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: NCT00396266
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : November 25, 2010
Last Update Posted : March 7, 2014
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Lymphoma, Non-Hodgkin
Intervention Drug: G-CSF Plus Plerixafor
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Hide Arm/Group Description Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Period Title: Overall Study
Started 8 14
Completed 8 14
Not Completed 0 0
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) Total
Hide Arm/Group Description Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Total of all reporting groups
Overall Number of Baseline Participants 8 14 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 14 participants 22 participants
57.9  (8.7) 57.5  (10.3) 57.6  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 14 participants 22 participants
Female
3
  37.5%
4
  28.6%
7
  31.8%
Male
5
  62.5%
10
  71.4%
15
  68.2%
1.Primary Outcome
Title Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
Hide Description Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Time Frame Day 1 to approximately Day 38 (before start of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all participants who received at least 1 dose of plerixafor.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) Total
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All patients.
Overall Number of Participants Analyzed 8 14 22
Measure Type: Number
Unit of Measure: participants
AE Severity (Mild) 4 8 12
AE Severity (Moderate) 4 6 10
AE Severity (Severe) 0 0 0
AE Relationship to Drug (Not related) 0 0 0
AE Relationship to Drug (Probably not related) 2 3 5
AE Relationship to Drug (Possibly related) 0 5 5
AE Relationship to Drug(Probably related) 4 5 9
AE Relationship to Drug (Definitely related) 2 1 3
2.Secondary Outcome
Title Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells
Hide Description To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.
Time Frame Time 0 to 11 hours after the first dose of plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description

The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).

One participant excluded from the analysis because data was missing.

Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) Total
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All patients.
Overall Number of Participants Analyzed 8 13 21
Measure Type: Number
Unit of Measure: participants
≥ 2-fold Increase 8 13 21
< 2-fold Increase 0 0 0
3.Secondary Outcome
Title Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-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 of participants who had transplants. One participant received a tandem transplant.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) Total
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All patients.
Overall Number of Participants Analyzed 8 14 22
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants
8 15 23
Measure Type: Number
Unit of Measure: number of transplants
≤ Day 12 7 10 17
Day 13 to Day 21 1 5 6
≥ Day 22 0 0 0
4.Secondary Outcome
Title Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment
Hide Description In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation.
Time Frame Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed due to sample degradation.
Arm/Group Title Non-hodgkin's Lymphoma (NHL)
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Single-dose Maximum Observed Concentration of Plerixafor (Cmax)
Hide Description Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.
Time Frame Day 5 - 0 to 10 hours post-first plerixafor dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
Arm/Group Title PK Subgroup
Hide Arm/Group Description:
Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
926  (237)
6.Secondary Outcome
Title Single-dose Time to Maximum Concentration of Plerixafor (Tmax)
Hide Description Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.
Time Frame Day 5 - 0 to 10 hours post-first plerixafor dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
Arm/Group Title PK Subgroup
Hide Arm/Group Description:
Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
0.5
(0.3 to 1.0)
7.Secondary Outcome
Title Single-dose Half-life of Plerixafor (T1/2)
Hide Description Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis.
Time Frame Day 5 - 0 to 10 hours post-first plerixafor dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
Arm/Group Title PK Subgroup
Hide Arm/Group Description:
Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: hours
5.1  (2.2)
8.Secondary Outcome
Title Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10)
Hide Description Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis.
Time Frame Day 5 - 0 to 10 hours post-first plerixafor dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
Arm/Group Title PK Subgroup
Hide Arm/Group Description:
Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
3594  (697)
9.Secondary Outcome
Title Single-dose Apparent Clearance of Plerixafor (CL/F)
Hide Description Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis.
Time Frame Day 5 - 0 to 10 hours post-first plerixafor dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
Arm/Group Title PK Subgroup
Hide Arm/Group Description:
Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mL/hour
4767  (1063)
10.Secondary Outcome
Title Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients
Hide Description Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.
Time Frame Day 5 - 0 to 10 hours post-first plerixafor dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
Arm/Group Title PK Subgroup
Hide Arm/Group Description:
Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mL
33668  (10531)
11.Secondary Outcome
Title Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor
Hide Description A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).
Time Frame Day 4 (10 hours post first plerixafor dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.
Arm/Group Title PD Subgroup
Hide Arm/Group Description:
Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: ratio
4.2
(3.0 to 5.5)
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

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) Multiple Myeloma (MM)
Hide Arm/Group Description Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All-Cause Mortality
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   2/14 (14.29%) 
General disorders     
Catheter site haemorrhage  1  1/8 (12.50%)  1/14 (7.14%) 
Catheter site pain  1  0/8 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Catheter bacteraemia  1  0/8 (0.00%)  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   14/14 (100.00%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/8 (12.50%)  0/14 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  0/8 (0.00%)  1/14 (7.14%) 
Abdominal pain upper  1  0/8 (0.00%)  2/14 (14.29%) 
Constipation  1  1/8 (12.50%)  0/14 (0.00%) 
Diarrhoea  1  1/8 (12.50%)  7/14 (50.00%) 
Dyspepsia  1  0/8 (0.00%)  1/14 (7.14%) 
Flatulence  1  0/8 (0.00%)  1/14 (7.14%) 
Hypoaesthesia oral  1  0/8 (0.00%)  1/14 (7.14%) 
Nausea  1  3/8 (37.50%)  4/14 (28.57%) 
Retching  1  1/8 (12.50%)  0/14 (0.00%) 
Toothache  1  0/8 (0.00%)  1/14 (7.14%) 
General disorders     
Asthenia  1  0/8 (0.00%)  1/14 (7.14%) 
Catheter site erythema  1  1/8 (12.50%)  6/14 (42.86%) 
Catheter site haematoma  1  1/8 (12.50%)  0/14 (0.00%) 
Catheter site haemorrhage  1  0/8 (0.00%)  1/14 (7.14%) 
Catheter site pain  1  2/8 (25.00%)  3/14 (21.43%) 
Catheter site pruritus  1  0/8 (0.00%)  1/14 (7.14%) 
Catheter site rash  1  0/8 (0.00%)  1/14 (7.14%) 
Catheter site related reaction  1  1/8 (12.50%)  0/14 (0.00%) 
Chest discomfort  1  0/8 (0.00%)  1/14 (7.14%) 
Chest pain  1  1/8 (12.50%)  0/14 (0.00%) 
Chills  1  0/8 (0.00%)  1/14 (7.14%) 
Fatigue  1  3/8 (37.50%)  6/14 (42.86%) 
Influenza like illness  1  0/8 (0.00%)  1/14 (7.14%) 
Injection site bruising  1  0/8 (0.00%)  1/14 (7.14%) 
Injection site erythema  1  4/8 (50.00%)  6/14 (42.86%) 
Injection site irritation  1  1/8 (12.50%)  1/14 (7.14%) 
Injection site pain  1  1/8 (12.50%)  3/14 (21.43%) 
Injection site pruritus  1  1/8 (12.50%)  2/14 (14.29%) 
Injection site swelling  1  0/8 (0.00%)  2/14 (14.29%) 
Oedema peripheral  1  0/8 (0.00%)  1/14 (7.14%) 
Pyrexia  1  0/8 (0.00%)  3/14 (21.43%) 
Swelling  1  0/8 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Influenza  1  0/8 (0.00%)  1/14 (7.14%) 
Upper respiratory tract infection  1  0/8 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications     
Contusion  1  0/8 (0.00%)  1/14 (7.14%) 
Investigations     
Blood glucose increased  1  0/8 (0.00%)  1/14 (7.14%) 
Heart rate increased  1  1/8 (12.50%)  0/14 (0.00%) 
Urine output increased  1  1/8 (12.50%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/8 (12.50%)  0/14 (0.00%) 
Hypokalaemia  1  1/8 (12.50%)  0/14 (0.00%) 
Hypomagnesaemia  1  0/8 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/8 (25.00%)  1/14 (7.14%) 
Back pain  1  4/8 (50.00%)  2/14 (14.29%) 
Bone pain  1  1/8 (12.50%)  6/14 (42.86%) 
Joint stiffness  1  0/8 (0.00%)  1/14 (7.14%) 
Muscle spasms  1  2/8 (25.00%)  2/14 (14.29%) 
Musculoskeletal discomfort  1  1/8 (12.50%)  2/14 (14.29%) 
Musculoskeletal pain  1  1/8 (12.50%)  0/14 (0.00%) 
Musculoskeletal stiffness  1  0/8 (0.00%)  1/14 (7.14%) 
Myalgia  1  1/8 (12.50%)  2/14 (14.29%) 
Pain in extremity  1  1/8 (12.50%)  1/14 (7.14%) 
Nervous system disorders     
Dizziness  1  0/8 (0.00%)  2/14 (14.29%) 
Headache  1  3/8 (37.50%)  1/14 (7.14%) 
Hypoaesthesia  1  0/8 (0.00%)  1/14 (7.14%) 
Paraesthesia  1  4/8 (50.00%)  1/14 (7.14%) 
Sensory loss  1  0/8 (0.00%)  1/14 (7.14%) 
Psychiatric disorders     
Anxiety  1  1/8 (12.50%)  1/14 (7.14%) 
Renal and urinary disorders     
Pollakiuria  1  1/8 (12.50%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/8 (0.00%)  1/14 (7.14%) 
Dyspnoea  1  1/8 (12.50%)  2/14 (14.29%) 
Dyspnoea exertional  1  1/8 (12.50%)  2/14 (14.29%) 
Nasal congestion  1  0/8 (0.00%)  1/14 (7.14%) 
Pharyngolaryngeal pain  1  1/8 (12.50%)  0/14 (0.00%) 
Productive cough  1  1/8 (12.50%)  0/14 (0.00%) 
Rhinorrhoea  1  0/8 (0.00%)  1/14 (7.14%) 
Sleep apnoea syndrome  1  0/8 (0.00%)  1/14 (7.14%) 
Throat irritation  1  1/8 (12.50%)  0/14 (0.00%) 
Throat tightness  1  1/8 (12.50%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/8 (12.50%)  0/14 (0.00%) 
Night sweats  1  1/8 (12.50%)  0/14 (0.00%) 
Swelling face  1  0/8 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Flushing  1  1/8 (12.50%)  2/14 (14.29%) 
Pallor  1  1/8 (12.50%)  0/14 (0.00%) 
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: NCT00396266    
Other Study ID Numbers: AMD3100-C201
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: October 30, 2010
Results First Posted: November 25, 2010
Last Update Posted: March 7, 2014