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Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT00322491
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : November 24, 2010
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
AnorMED
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Non-Hodgkin
Multiple Myeloma
Intervention Drug: G-CSF Plus Plerixafor
Enrollment 49
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 23 26
Completed 21 24
Not Completed 2 2
Reason Not Completed
Adverse Event             1             0
Death             1             2
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 23 26 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 26 participants 49 participants
56.5  (8.7) 57.6  (8.1) 57.1  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 49 participants
Female
9
  39.1%
10
  38.5%
19
  38.8%
Male
14
  60.9%
16
  61.5%
30
  61.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 49 participants
Caucasian 23 23 46
African-American 0 1 1
Hispanic/Latino 0 1 1
Other 0 1 1
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 (approximately day 38). 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) All Participants
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.
[Not Specified]
Overall Number of Participants Analyzed 23 26 49
Measure Type: Number
Unit of Measure: participants
Participants reporting ≥ 1 Adverse Event 23 26 49
AE Severity (Mild) 8 9 17
AE Severity (Moderate) 5 2 7
AE Severity (Severe) 10 15 25
AE Relationship to Drug (Not Related) 0 4 4
AE Relationship to Drug (Probably Not Related) 1 4 5
AE Relationship to Drug (Possibly Related) 12 5 17
AE Relationship to Drug (Probably Related) 8 11 19
AE Relationship to Drug (Definitely Related) 2 2 4
2.Secondary Outcome
Title Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor
Hide Description The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)
Time Frame Days 4-5 (first dose of plerixafor to apheresis)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
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.
[Not Specified]
Overall Number of Participants Analyzed 23 26 49
Measure Type: Number
Unit of Measure: participants
≥ 2-fold Increase 20 17 37
< 2-fold Increase 3 9 12
3.Secondary Outcome
Title Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Hide Description Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a transplant. Two participants in the MM group received a second transplant.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
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.
[Not Specified]
Overall Number of Participants Analyzed 22 25 47
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants
22 27 49
Measure Type: Number
Unit of Measure: number of transplants
≤ Day 12 19 20 39
Day 13 to Day 21 3 7 10
≥ Day 22 0 0 0
4.Other Pre-specified Outcome
Title Median Cumulative Number of CD34+ Cells Collected During Apheresis
Hide Description Median cumulative total number of CD34+ cells collected during apheresis.
Time Frame Days 5-8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of plerixafor
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
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.
[Not Specified]
Overall Number of Participants Analyzed 23 26 49
Median (Full Range)
Unit of Measure: CD34+ cells (*10^6 / kg)
5.2
(1.5 to 18.9)
11.1
(4.4 to 22.5)
5.9
(1.5 to 22.5)
5.Other Pre-specified Outcome
Title Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Hide Description Participants were monitored for platelet (PLT) 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
A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
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.
[Not Specified]
Overall Number of Participants Analyzed 22 24 46
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants
22 26 48
Measure Type: Number
Unit of Measure: number of transplants
≤ Day 12 7 7 14
Day 13 to Day 21 10 18 28
≥ Day 22 5 1 6
6.Other Pre-specified Outcome
Title Number of Participants With Durable Engraftment 12 Months After Transplantation
Hide Description The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Time Frame Approximately 13 months (12 months post-transplant )
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
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.
[Not Specified]
Overall Number of Participants Analyzed 21 23 44
Measure Type: Number
Unit of Measure: participants
21 22 43
Time Frame First day of G-CSF administration to the day prior to chemotherapy/ablative treatment in preparation of first transplant. This period includes the G-CSF, plerixafor treatment and rest period.
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.
 
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) 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   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   1/26 (3.85%) 
General disorders     
Heparin-induced thrombocytopenia  1  0/23 (0.00%)  1/26 (3.85%) 
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%
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   23/23 (100.00%)   26/26 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  4/23 (17.39%)  5/26 (19.23%) 
Lymphopenia  1  3/23 (13.04%)  5/26 (19.23%) 
Thrombocytopenia  1  5/23 (21.74%)  3/26 (11.54%) 
Cardiac disorders     
Palpitations  1  0/23 (0.00%)  1/26 (3.85%) 
Eye disorders     
Ocular hyperaemia  1  1/23 (4.35%)  0/26 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/23 (4.35%)  0/26 (0.00%) 
Abdominal distension  1  0/23 (0.00%)  2/26 (7.69%) 
Abdominal pain  1  4/23 (17.39%)  0/26 (0.00%) 
Constipation  1  1/23 (4.35%)  1/26 (3.85%) 
Diarrhoea  1  13/23 (56.52%)  10/26 (38.46%) 
Dyspepsia  1  2/23 (8.70%)  1/26 (3.85%) 
Flatulence  1  3/23 (13.04%)  1/26 (3.85%) 
Gingival bleeding  1  1/23 (4.35%)  0/26 (0.00%) 
Hyperchlorhydria  1  0/23 (0.00%)  1/26 (3.85%) 
Nausea  1  9/23 (39.13%)  8/26 (30.77%) 
Oral pain  1  1/23 (4.35%)  0/26 (0.00%) 
Paraesthesia oral  1  0/23 (0.00%)  3/26 (11.54%) 
Salivary hypersecretion  1  1/23 (4.35%)  0/26 (0.00%) 
Stomach discomfort  1  1/23 (4.35%)  0/26 (0.00%) 
Vomiting  1  1/23 (4.35%)  1/26 (3.85%) 
General disorders     
Asthenia  1  1/23 (4.35%)  0/26 (0.00%) 
Catheter related complication  1  1/23 (4.35%)  1/26 (3.85%) 
Catheter site discharge  1  0/23 (0.00%)  1/26 (3.85%) 
Catheter site erythema  1  1/23 (4.35%)  0/26 (0.00%) 
Catheter site haemorrhage  1  2/23 (8.70%)  1/26 (3.85%) 
Catheter site pain  1  2/23 (8.70%)  0/26 (0.00%) 
Catheter site pruritus  1  0/23 (0.00%)  1/26 (3.85%) 
Catheter site related reaction  1  0/23 (0.00%)  2/26 (7.69%) 
Catheter thrombosis  1  1/23 (4.35%)  0/26 (0.00%) 
Chest discomfort  1  1/23 (4.35%)  1/26 (3.85%) 
Chest pain  1  0/23 (0.00%)  2/26 (7.69%) 
Chills  1  0/23 (0.00%)  2/26 (7.69%) 
Fatigue  1  7/23 (30.43%)  4/26 (15.38%) 
Feeling cold  1  0/23 (0.00%)  1/26 (3.85%) 
Hunger  1  2/23 (8.70%)  0/26 (0.00%) 
Injection site erythema  1  6/23 (26.09%)  3/26 (11.54%) 
Injection site haemorrhage  1  2/23 (8.70%)  0/26 (0.00%) 
Injection site irritation  1  0/23 (0.00%)  1/26 (3.85%) 
Injection site pruritus  1  0/23 (0.00%)  1/26 (3.85%) 
Injection site swelling  1  1/23 (4.35%)  0/26 (0.00%) 
Irritability  1  1/23 (4.35%)  0/26 (0.00%) 
Oedema  1  1/23 (4.35%)  1/26 (3.85%) 
Oedema peripheral  1  0/23 (0.00%)  1/26 (3.85%) 
Pain  1  2/23 (8.70%)  2/26 (7.69%) 
Pyrexia  1  3/23 (13.04%)  1/26 (3.85%) 
Secretion discharge  1  1/23 (4.35%)  0/26 (0.00%) 
Infections and infestations     
Catheter related infection  1  0/23 (0.00%)  1/26 (3.85%) 
Oral candidiasis  1  0/23 (0.00%)  1/26 (3.85%) 
Tooth abscess  1  0/23 (0.00%)  1/26 (3.85%) 
Upper respiratory tract infection  1  1/23 (4.35%)  0/26 (0.00%) 
Urinary tract infection  1  0/23 (0.00%)  1/26 (3.85%) 
Injury, poisoning and procedural complications     
Blood stem cell harvest failure  1  1/23 (4.35%)  0/26 (0.00%) 
Neck injury  1  1/23 (4.35%)  0/26 (0.00%) 
Post procedural discomfort  1  1/23 (4.35%)  0/26 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/23 (4.35%)  1/26 (3.85%) 
Aspartate aminotransferase increased  1  1/23 (4.35%)  1/26 (3.85%) 
Bacteria stool identified  1  0/23 (0.00%)  1/26 (3.85%) 
Blood alkaline phosphatase decreased  1  0/23 (0.00%)  3/26 (11.54%) 
Blood alkaline phosphatase increased  1  3/23 (13.04%)  6/26 (23.08%) 
Blood lactate dehydrogenase increased  1  0/23 (0.00%)  1/26 (3.85%) 
Blood magnesium decreased  1  1/23 (4.35%)  0/26 (0.00%) 
Haemoglobin decreased  1  2/23 (8.70%)  0/26 (0.00%) 
Heart rate irregular  1  1/23 (4.35%)  0/26 (0.00%) 
Lymphocyte count abnormal  1  1/23 (4.35%)  0/26 (0.00%) 
White blood cell count increased  1  1/23 (4.35%)  0/26 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  2/23 (8.70%)  1/26 (3.85%) 
Hypokalaemia  1  5/23 (21.74%)  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/23 (4.35%)  1/26 (3.85%) 
Back pain  1  4/23 (17.39%)  1/26 (3.85%) 
Bone pain  1  7/23 (30.43%)  6/26 (23.08%) 
Joint stiffness  1  0/23 (0.00%)  1/26 (3.85%) 
Muscle spasms  1  3/23 (13.04%)  3/26 (11.54%) 
Muscle twitching  1  1/23 (4.35%)  0/26 (0.00%) 
Muscular weakness  1  1/23 (4.35%)  0/26 (0.00%) 
Musculoskeletal discomfort  1  1/23 (4.35%)  1/26 (3.85%) 
Musculoskeletal pain  1  2/23 (8.70%)  2/26 (7.69%) 
Myalgia  1  1/23 (4.35%)  1/26 (3.85%) 
Pain in extremity  1  1/23 (4.35%)  0/26 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma  1  1/23 (4.35%)  0/26 (0.00%) 
Nervous system disorders     
Dizziness  1  0/23 (0.00%)  2/26 (7.69%) 
Headache  1  9/23 (39.13%)  4/26 (15.38%) 
Hypoaesthesia  1  2/23 (8.70%)  1/26 (3.85%) 
Migraine  1  0/23 (0.00%)  1/26 (3.85%) 
Paraesthesia  1  4/23 (17.39%)  11/26 (42.31%) 
Peripheral sensory neuropathy  1  2/23 (8.70%)  1/26 (3.85%) 
Sinus headache  1  1/23 (4.35%)  0/26 (0.00%) 
Tremor  1  1/23 (4.35%)  1/26 (3.85%) 
Psychiatric disorders     
Abnormal dreams  1  0/23 (0.00%)  1/26 (3.85%) 
Anxiety  1  3/23 (13.04%)  2/26 (7.69%) 
Depression  1  0/23 (0.00%)  1/26 (3.85%) 
Insomnia  1  5/23 (21.74%)  6/26 (23.08%) 
Nervousness  1  1/23 (4.35%)  1/26 (3.85%) 
Renal and urinary disorders     
Haematuria  1  0/23 (0.00%)  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/23 (13.04%)  2/26 (7.69%) 
Dyspnoea  1  0/23 (0.00%)  3/26 (11.54%) 
Dyspnoea exertional  1  1/23 (4.35%)  0/26 (0.00%) 
Nasal congestion  1  1/23 (4.35%)  0/26 (0.00%) 
Pharyngolaryngeal pain  1  1/23 (4.35%)  1/26 (3.85%) 
Productive cough  1  0/23 (0.00%)  1/26 (3.85%) 
Rhinorrhoea  1  0/23 (0.00%)  1/26 (3.85%) 
Skin and subcutaneous tissue disorders     
Ecchymosis  1  1/23 (4.35%)  2/26 (7.69%) 
Erythema  1  1/23 (4.35%)  0/26 (0.00%) 
Hyperhidrosis  1  1/23 (4.35%)  1/26 (3.85%) 
Hypoaesthesia facial  1  0/23 (0.00%)  2/26 (7.69%) 
Night sweats  1  3/23 (13.04%)  1/26 (3.85%) 
Rash  1  0/23 (0.00%)  1/26 (3.85%) 
Vascular disorders     
Haemorrhage  1  1/23 (4.35%)  0/26 (0.00%) 
Hot flush  1  1/23 (4.35%)  0/26 (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
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00322491     History of Changes
Other Study ID Numbers: AMD3100-2105
First Submitted: May 4, 2006
First Posted: May 8, 2006
Results First Submitted: October 30, 2010
Results First Posted: November 24, 2010
Last Update Posted: March 13, 2014