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Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

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ClinicalTrials.gov Identifier: NCT00560794
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : January 7, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphoblastic Leukemia
Intervention Biological: Blinatumomab (MT103)
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Blinatumomab
Hide Arm/Group Description Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Period Title: Overall Study
Started 21
Completed 1 Treatment Cycle 20
Completed 10
Not Completed 11
Reason Not Completed
Adverse Event             2
Patient was not Compliant             1
Minimal Residual Disease Relapse             1
Hematological Relapse             1
Received Bone Marrow Transplant             6
Arm/Group Title Blinatumomab
Hide Arm/Group Description Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Full Analysis Set included all participants who received ≥ 1 infusion of blinatumomab who completed at least the first treatment cycle and for whom at least one minimal residual disease (MRD) response assessment was available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
49.8  (18.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
20-30 years 3
31-40 years 5
41-50 years 2
51-60 years 1
61-70 years 7
> 70 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
12
  60.0%
Male
8
  40.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 20 participants
20
Genetic Alterations   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
bcr/abl translocation above detection limit 5
t(4;11) translocation above detection limit 2
Rearrangements of Ig / TCR genes only 13
Rearrangements of Ig / TCR genes & translocations 3
[1]
Measure Description:

bcr/abl: breakpoint cluster region; Ig: immunoglobulin; TCR: T-cell receptor. For bcr/abl above detection limit and t(4;11) translocation above detection limit participants may have rearrangements in addition to translocations.

For Rearrangements of immunoglobulin / TCR genes participants did not show any translocation.

1.Primary Outcome
Title Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment
Hide Description

MRD Response is defined as:

  • If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.
  • If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.
Time Frame Within 4 treatment cycles, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.0
(56.3 to 94.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments The null hypothesis stated that the true MRD response probability (π) ≤ 5%.
Method 1-sided exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With an MRD Response After Each Treatment Cycle
Hide Description

MRD Response is defined as:

  • If Philadelphia Chromosome (Ph)+ or t(4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.
  • If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.
Time Frame At the end of each treatment cycle - Weeks 4, 10, 16, and 22.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MRD negativity achieved after cycle 1
80.0
(56.3 to 94.3)
MRD negativity achieved after cycle 2
80.0
(56.3 to 94.3)
MRD negativity achieved after cycle 3
80.0
(56.3 to 94.3)
MRD negativity achieved after cycle 4
80.0
(56.3 to 94.3)
3.Secondary Outcome
Title Time to Hematological Relapse
Hide Description

The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy.

Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods.

Time Frame Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
The median time to hematological relapse was not reached due to the low number of events
4.Secondary Outcome
Title Time to MRD Progression
Hide Description

Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation.

MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks.

Time Frame Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: days
221.0 [1] 
(170.0 to NA)
[1]
Could not be estimated due to the low number of events
5.Secondary Outcome
Title Time to MRD Relapse
Hide Description

Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring.

MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks.

Time Frame Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Median was not reached during the study due to the low number of events
6.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.

The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.

A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs.

Time Frame From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Any adverse event 21
Adverse events of at least CTC grade 3 17
Treatment-related adverse events 21
Related adverse events of at least CTC grade 3 13
Serious adverse evets 10
Related serious adverse events 9
AEs leading to discontinuation of blinatumomab 1
AEs leading to death 0
7.Secondary Outcome
Title Change From Screening Value in B-cell Count During Cycle 1
Hide Description B-cells were measured by flow cytometry.
Time Frame At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received blinatumomab with available pharmacodynamic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cells/μL
Start of infusion (N=19) 0.0181  (0.0803)
45 minutes (N=19) -0.0098  (0.0402)
2 hours (N=18) -0.0361  (0.0621)
6 hours (N=19) -0.0435  (0.0685)
12 hours (N=16) -0.0417  (0.0689)
24 hours (N=18) -0.0403  (0.0700)
Day 2 (N=17) -0.0310  (0.0589)
Day 7 (N=18) -0.0462  (0.0717)
Day 14 (N=18) -0.0490  (0.0745)
Day 21 (N=18) -0.0494  (0.0747)
Day 28 (N=17) -0.0392  (0.0634)
Day 35 (N=18) -0.0493  (0.0748)
8.Secondary Outcome
Title Change From Screening Value in T-cell Count During Cycle 1
Hide Description T-cells were measured by flow cytometry.
Time Frame At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received blinatumomab with available pharmacodynamic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cells/μL
Start of infusion (N=19) -0.0418  (0.2925)
45 minutes (N=19) -0.3208  (0.3137)
2 hours (N=18) -0.4976  (0.3454)
6 hours (N=19) -0.5227  (0.3432)
12 hours (N=16) -0.5390  (0.3649)
24 hours (N=18) -0.4780  (0.3774)
Day 2 (N=17) -0.3328  (0.3704)
Day 7 (N=18) 0.1231  (0.3051)
Day 14 (N=18) 0.1172  (0.4671)
Day 21 (N=18) 0.1975  (0.5596)
Day 28 (N=17) 0.1687  (0.3119)
Day 35 (N=18) 0.2271  (0.3739)
9.Secondary Outcome
Title Serum Cytokine Peak Levels in Cycle 1
Hide Description The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL.
Time Frame Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: pg/mL
IL-2 NA [1]   (NA)
IL-4 NA [2]   (NA)
IL-6 693.2  (1122.9)
IL-8 NA [2]   (NA)
IL-10 1135.3  (1155.6)
IFN-γ 408.5  (614.3)
TNF-α NA [1]   (NA)
[1]
Levels less than the limit of quantitation
[2]
Levels less than the limit of detection
10.Secondary Outcome
Title Serum Blinatumomab Concentration at Steady State
Hide Description The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL.
Time Frame Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: pg/mL
696  (147)
11.Secondary Outcome
Title Area Under the Drug Concentration-time Curve From Time Zero to Infinity
Hide Description [Not Specified]
Time Frame Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
481  (106)
12.Secondary Outcome
Title Apparent Volume of Distribution
Hide Description [Not Specified]
Time Frame Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: L/m²
2.00  (0.95)
13.Secondary Outcome
Title Clearance of Blinatumomab
Hide Description [Not Specified]
Time Frame Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: L/hr/m²
0.939  (0.199)
14.Secondary Outcome
Title Terminal Half-life of Blinatumomab
Hide Description [Not Specified]
Time Frame Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: hours
1.47  (0.53)
Time Frame From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Adverse Event Reporting Description

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Summary of Adverse Events includes only those participants who received at least one dose of investigational product.

 
Arm/Group Title Blinatumomab
Hide Arm/Group Description Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
All-Cause Mortality
Blinatumomab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Blinatumomab
Affected / at Risk (%)
Total   10/21 (47.62%) 
Blood and lymphatic system disorders   
Leukopenia  1  1/21 (4.76%) 
Lymphopenia  1  6/21 (28.57%) 
Thrombocytopenia  1  1/21 (4.76%) 
Infections and infestations   
Bacterial sepsis  1  1/21 (4.76%) 
Bronchopneumonia  1  1/21 (4.76%) 
Catheter related infection  1  1/21 (4.76%) 
Escherichia sepsis  1  1/21 (4.76%) 
Injury, poisoning and procedural complications   
Medical device complication  1  1/21 (4.76%) 
Thrombosis in device  1  1/21 (4.76%) 
Nervous system disorders   
Convulsion  1  1/21 (4.76%) 
Epilepsy  1  1/21 (4.76%) 
Somnolence  1  1/21 (4.76%) 
Syncope  1  1/21 (4.76%) 
Vascular disorders   
Hypertension  1  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Blinatumomab
Affected / at Risk (%)
Total   21/21 (100.00%) 
Blood and lymphatic system disorders   
Leukopenia  1  7/21 (33.33%) 
Lymphopenia  1  5/21 (23.81%) 
Thrombocytopenia  1  6/21 (28.57%) 
Cardiac disorders   
Bradycardia  1  2/21 (9.52%) 
Tachycardia  1  4/21 (19.05%) 
Eye disorders   
Lacrimation increased  1  2/21 (9.52%) 
Gastrointestinal disorders   
Constipation  1  4/21 (19.05%) 
Diarrhoea  1  5/21 (23.81%) 
Dry mouth  1  2/21 (9.52%) 
Nausea  1  5/21 (23.81%) 
Vomiting  1  3/21 (14.29%) 
General disorders   
Catheter site erythema  1  2/21 (9.52%) 
Catheter site pain  1  2/21 (9.52%) 
Chills  1  9/21 (42.86%) 
Fatigue  1  8/21 (38.10%) 
Oedema peripheral  1  8/21 (38.10%) 
Pyrexia  1  21/21 (100.00%) 
Immune system disorders   
Immunodeficiency  1  2/21 (9.52%) 
Infections and infestations   
Bronchitis  1  2/21 (9.52%) 
Cystitis  1  2/21 (9.52%) 
Nasopharyngitis  1  7/21 (33.33%) 
Oral herpes  1  2/21 (9.52%) 
Pharyngitis  1  2/21 (9.52%) 
Sinusitis  1  2/21 (9.52%) 
Investigations   
Alanine aminotransferase increased  1  4/21 (19.05%) 
Blood alkaline phosphatase increased  1  2/21 (9.52%) 
Blood immunoglobulin A decreased  1  14/21 (66.67%) 
Blood immunoglobulin G decreased  1  13/21 (61.90%) 
Blood immunoglobulin M decreased  1  10/21 (47.62%) 
Blood lactate dehydrogenase increased  1  2/21 (9.52%) 
Blood potassium decreased  1  3/21 (14.29%) 
C-reactive protein increased  1  6/21 (28.57%) 
Coagulation factor XIII level increased  1  2/21 (9.52%) 
Fibrin D dimer increased  1  4/21 (19.05%) 
Gamma-glutamyltransferase increased  1  5/21 (23.81%) 
Immunoglobulins decreased  1  2/21 (9.52%) 
Monocyte count increased  1  2/21 (9.52%) 
Weight decreased  1  4/21 (19.05%) 
Weight increased  1  7/21 (33.33%) 
Metabolism and nutrition disorders   
Anorexia  1  2/21 (9.52%) 
Hyperglycaemia  1  4/21 (19.05%) 
Hypokalaemia  1  10/21 (47.62%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/21 (9.52%) 
Back pain  1  6/21 (28.57%) 
Growing pains  1  5/21 (23.81%) 
Myalgia  1  2/21 (9.52%) 
Neck pain  1  2/21 (9.52%) 
Pain in extremity  1  2/21 (9.52%) 
Nervous system disorders   
Dizziness  1  5/21 (23.81%) 
Headache  1  10/21 (47.62%) 
Tremor  1  5/21 (23.81%) 
Psychiatric disorders   
Insomnia  1  5/21 (23.81%) 
Renal and urinary disorders   
Haematuria  1  5/21 (23.81%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/21 (14.29%) 
Dyspnoea  1  5/21 (23.81%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  3/21 (14.29%) 
Night sweats  1  2/21 (9.52%) 
Periorbital oedema  1  4/21 (19.05%) 
Rash  1  5/21 (23.81%) 
Vascular disorders   
Hypertension  1  2/21 (9.52%) 
Hypotension  1  5/21 (23.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier: NCT00560794    
Other Study ID Numbers: MT103-202
2006-006520-19 ( EudraCT Number )
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: December 23, 2014
Results First Posted: January 7, 2015
Last Update Posted: January 26, 2015