Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00844649
First received: February 13, 2009
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: October 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Pancreatic Cancer
Interventions: Drug: Albumin-bound paclitaxel
Drug: Gemcitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)

Reporting Groups
  Description
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine (Gem) Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

Participant Flow:   Overall Study
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)     Gemcitabine (Gem)  
STARTED     431 [1]   430 [1]
Treated Population     421 [2]   402 [2]
COMPLETED     26 [3]   12 [3]
NOT COMPLETED     405     418  
Progressive Disease                 196                 245  
Adverse Event                 128                 73  
Physician Decision                 25                 18  
Protocol Violation                 10                 6  
Withdrawal by Subject                 28                 39  
Unspecified                 7                 10  
Withdrew prior to starting treatment                 11                 27  
[1] Started = Intent to Treat Population and includes all randomized participants
[2] Treated population = all randomized patients who received at least one dose of study drug
[3] Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For the KPS baseline characteristic, some of the participants did not have a baseline KPS recorded by the clinical site.

Reporting Groups
  Description
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine

ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.

Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest

Gemcitabine

Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).

Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Total Total of all reporting groups

Baseline Measures
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine     Gemcitabine     Total  
Number of Participants  
[units: participants]
  431     430     861  
Age  
[units: years]
Mean ± Standard Deviation
  61.4  ± 10.70     63.0  ± 9.27     62.2  ± 10.04  
Gender  
[units: participants]
     
Female     186     173     359  
Male     245     257     502  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     8     9     17  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     16     16     32  
White     378     375     753  
More than one race     25     26     51  
Unknown or Not Reported     3     4     7  
Karnofsky Performance Status (KPS) [1]
[units: participants]
     
100% = normal, no complaints, no signs of disease     69     69     138  
90% = normal activity, few symptoms of disease     179     199     378  
80% = normal activity, some symptoms of disease     149     128     277  
70% = caring for self, unable to work     30     33     63  
60% = needs help, can manage most tasks     2     0     2  
50% = needs help often and medical care     0     0     0  
40% = disabled; requires special care & assistance     0     0     0  
30% = severely disabled; death is imminent     0     0     0  
20% = hospitalized; requires supportive treatment     0     0     0  
10% = Moribund, fatal processes progressing fast     0     0     0  
0% = Dead     0     0     0  
Pancreatic Primary Tumor Location [2]
[units: participants]
     
Head     191     180     371  
Body     132     136     268  
Tail     105     110     215  
Unknown = not specified     3     4     7  
Number of Baseline Lesions (Target + Non-Target) [3]
[units: participants]
     
1     1     0     1  
2     32     25     57  
3     7     7     14  
4     37     43     80  
5     8     8     16  
>5     276     262     538  
[1] The Karnofsky Performance Status Scale (KPS) was designed to measure the level of participant activity and medical care requirements. A general measure of participant independence and has been widely used as a general assessment of participants with cancer. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. The primary purpose of its development was to allow physicians to evaluate a participant's ability to survive chemotherapy for cancer. Two participants from the Albumin bound paclitaxel arm and one from the Gemcitabine arm did not have KPS performed.
[2] Main location or area of the pancreas where the disease is detected at diagnosis. Unknown location refers to disease area not being specified.
[3] Target lesions are those measurable at baseline and are generally the largest lesions, most reliably measured and most representative of the participants sites of disease. Non target lesions are all of the sites of disease present at baseline not classified as target lesions. They include bone and cystic lesions and pleural/pericardial effusion/ascites. The Independent Radiology Reviewers (IRR) only evaluated scans for those with baseline and follow-up scans.



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. ]

2.  Secondary:   Progression-free Survival (PFS) by Independent Radiological Review (IRR)   [ Time Frame: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. ]

3.  Secondary:   Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)   [ Time Frame: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months ]

4.  Other Pre-specified:   Participants With Treatment Emergent Adverse Events (AE)   [ Time Frame: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days ]

5.  Other Pre-specified:   Number of Participants With Dose Reductions   [ Time Frame: Maximum time on treatment was 666 days ]

6.  Other Pre-specified:   Number of Participants With Dose Interruptions   [ Time Frame: Maximum time on treatment was 666 days ]

7.  Other Pre-specified:   Number of Participants With Dose Delays/Doses Not Given   [ Time Frame: Up to 666 days ]


  Serious Adverse Events
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Time Frame Day 1 up to 30 days after the last dose (a maximum of 666 days)
Additional Description No text entered.

Reporting Groups
  Description
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

Serious Adverse Events
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine     Gemcitabine  
Total, serious adverse events      
# participants affected / at risk     212/421 (50.36%)     172/402 (42.79%)  
Blood and lymphatic system disorders      
Febrile neutropenia † 1    
# participants affected / at risk     11/421 (2.61%)     2/402 (0.50%)  
Anaemia † 1    
# participants affected / at risk     9/421 (2.14%)     2/402 (0.50%)  
Neutropenia † 1    
# participants affected / at risk     4/421 (0.95%)     1/402 (0.25%)  
Pancytopenia † 1    
# participants affected / at risk     3/421 (0.71%)     0/402 (0.00%)  
Haemolytic uraemic syndrome † 1    
# participants affected / at risk     2/421 (0.48%)     1/402 (0.25%)  
Leukopenia † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Haemorrhagic anaemia † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/421 (0.24%)     3/402 (0.75%)  
Thrombotic thrombocytopenic purpura † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Leukocytosis † 1    
# participants affected / at risk     0/421 (0.00%)     2/402 (0.50%)  
Cardiac disorders      
Cardiac failure congestive † 1    
# participants affected / at risk     3/421 (0.71%)     1/402 (0.25%)  
Atrial Fibrillation † 1    
# participants affected / at risk     2/421 (0.48%)     3/402 (0.75%)  
Myocardial Infarction † 1    
# participants affected / at risk     2/421 (0.48%)     1/402 (0.25%)  
Acute coronary syndrome † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Atrial tachycardia † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cardiac arrest † 1    
# participants affected / at risk     1/421 (0.24%)     3/402 (0.75%)  
Cardiogenic shock † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Angina unstable † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Cardiopulmonary Failure † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Myocardial ischaemia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Pericardial effusion † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Eye disorders      
Visual acuity reduced † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Gastrointestinal disorders      
Vomiting † 1    
# participants affected / at risk     18/421 (4.28%)     12/402 (2.99%)  
Abdominal Pain † 1    
# participants affected / at risk     11/421 (2.61%)     10/402 (2.49%)  
Nausea † 1    
# participants affected / at risk     11/421 (2.61%)     8/402 (1.99%)  
Diarrhoea † 1    
# participants affected / at risk     9/421 (2.14%)     3/402 (0.75%)  
Ascites † 1    
# participants affected / at risk     4/421 (0.95%)     5/402 (1.24%)  
Intestinal obstruction † 1    
# participants affected / at risk     4/421 (0.95%)     1/402 (0.25%)  
Small intestinal obstruction † 1    
# participants affected / at risk     4/421 (0.95%)     1/402 (0.25%)  
Duodenal Obstruction † 1    
# participants affected / at risk     3/421 (0.71%)     2/402 (0.50%)  
Colitis † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Ileus † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Pancreatitis † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Upper gastrointestinal haemorrhage † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Abdominal pain upper † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Colitis Ischaemic † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Faecaloma † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Impaired gastric empyting † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Intestinal perforation † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Melaena † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Mesenteric vein thrombosis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Obstruction gastric † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Oesophageal varices haemorrhage † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Pancreatic cyst rupture † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Pancreatic pseudocyst † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Regurgitation † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Colitis microscopic † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Haematemesis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Large Intestine perforation † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Pancreatic haemorrhage † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Small intestinal haemorrhage † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Splenic artery aneurysm † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Constipation † 1    
# participants affected / at risk     5/421 (1.19%)     6/402 (1.49%)  
Duodenal stenosis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Gastric haemorrhage † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     0/421 (0.00%)     6/402 (1.49%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     27/421 (6.41%)     9/402 (2.24%)  
Oedema peripheral † 1    
# participants affected / at risk     6/421 (1.43%)     3/402 (0.75%)  
Asthenia † 1    
# participants affected / at risk     3/421 (0.71%)     5/402 (1.24%)  
Fatigue † 1    
# participants affected / at risk     3/421 (0.71%)     2/402 (0.50%)  
General physical health deterioration † 1    
# participants affected / at risk     2/421 (0.48%)     1/402 (0.25%)  
Chills † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Mucosal inflammation † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Multi-organ failure † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Pain † 1    
# participants affected / at risk     1/421 (0.24%)     2/402 (0.50%)  
Systemic inflammatory response syndrome † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Device occlusion † 1    
# participants affected / at risk     0/421 (0.00%)     2/402 (0.50%)  
Face oedema † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Localised oedema † 1    
# participants affected / at risk     0/421 (0.00%)     3/402 (0.75%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Sudden death † 1    
# participants affected / at risk     0/421 (0.00%)     2/402 (0.50%)  
Adverse drug reaction † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Generalized oedema † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hepatobiliary disorders      
Cholangitis † 1    
# participants affected / at risk     10/421 (2.38%)     5/402 (1.24%)  
Bile duct obstruction † 1    
# participants affected / at risk     4/421 (0.95%)     3/402 (0.75%)  
Jaundice † 1    
# participants affected / at risk     4/421 (0.95%)     1/402 (0.25%)  
Hyperbilirubinaemia † 1    
# participants affected / at risk     2/421 (0.48%)     1/402 (0.25%)  
Cholecystitis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cholecystitis acute † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Hepatic function abnormal † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Hepatotoxicity † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cholangitis acute † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Gallbladder perforation † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hepatic cirrhosis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hepatic failure † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Jaundice cholestatic † 1    
# participants affected / at risk     4/421 (0.95%)     3/402 (0.75%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     17/421 (4.04%)     11/402 (2.74%)  
Cellulitis † 1    
# participants affected / at risk     8/421 (1.90%)     5/402 (1.24%)  
Sepsis † 1    
# participants affected / at risk     5/421 (1.19%)     5/402 (1.24%)  
Septic Shock † 1    
# participants affected / at risk     4/421 (0.95%)     5/402 (1.24%)  
Bacterial Sepsis † 1    
# participants affected / at risk     3/421 (0.71%)     0/402 (0.00%)  
Lower Respiratory tract infection † 1    
# participants affected / at risk     3/421 (0.71%)     2/402 (0.50%)  
Catheter site infection † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Clostridium difficile colitis † 1    
# participants affected / at risk     2/421 (0.48%)     1/402 (0.25%)  
Klebsiella bacteraemia † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Liver Abscess † 1    
# participants affected / at risk     2/421 (0.48%)     3/402 (0.75%)  
Neutropenic sepsis † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Bacteraemia † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Biliary sepsis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cellulitis of male external genital organ † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Clostridial infection † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Device related infection † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Escherichia bacteraemia † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Gastroenteritis viral † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Infection † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Laryngitis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Lung Infection † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Oral Candidiasis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Perirectal abscess † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Pneumonia bacterial † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Pneumonia primary atypical † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Postoperative wound infection † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Pseudomonal sepsis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Skin Infection † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Tooth abscess † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Tooth Infection † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Urosepsis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Biliary abscess † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Breast cellulitis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Gastroenteritis clostridial † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Infected dermal cyst † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Klebsiella sepsis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Lung infection pseudomonal † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Streptococcal bacteraemia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Perihepatic abscess † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Injury, poisoning and procedural complications      
Urinary Tract Infection † 1    
# participants affected / at risk     6/421 (1.43%)     1/402 (0.25%)  
Accidental overdose † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Fall † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Subdural haematoma † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cervical vertebral fracture † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
In-stent coronary artery restenosis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Investigations      
Liver Function test abnormal † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Alanine aminotransferase increased † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Blood alkaline phosphatase increased † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Gamma-glutamyltransferase increased † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Haemoglobulin decreased † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Platelet count decreased † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Transaminases increased † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Heart rate increased † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Neutrophil count decreased † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Weight decreased † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Blood bilirubin increased † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Metabolism and nutrition disorders      
Dehyration † 1    
# participants affected / at risk     20/421 (4.75%)     12/402 (2.99%)  
Decreased Appetite † 1    
# participants affected / at risk     5/421 (1.19%)     0/402 (0.00%)  
Hyperkalaemia † 1    
# participants affected / at risk     0/421 (0.00%)     3/402 (0.75%)  
Hyponatraemia † 1    
# participants affected / at risk     2/421 (0.48%)     1/402 (0.25%)  
Diabetic ketoacidosis † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Failure to thrive † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Hyperglycaemia † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Hypoglycaemia † 1    
# participants affected / at risk     1/421 (0.24%)     3/402 (0.75%)  
Hypoalbuminaemia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hypovolaemia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Pseudohyponatraemia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hypokalaemia † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Musculoskeletal pain † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Musculoskeletal chest pain † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Back pain † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Joint swelling † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Muscular weakness † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Benign anorectal neoplasm † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Malignant ascites † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Metastatic pain † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Tumour associated fever † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Lymphangiosis carcinomatosa † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Meningioma benign † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Pancreatic carcinoma metastatic † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Nervous system disorders      
Cerebral ischaemia † 1    
# participants affected / at risk     2/421 (0.48%)     2/402 (0.50%)  
Peripheral motor neuropathy † 1    
# participants affected / at risk     2/421 (0.48%)     0/402 (0.00%)  
Autonomic nervous system imbalance † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cerebral infarction † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Cerebrovascular accident † 1    
# participants affected / at risk     1/421 (0.24%)     5/402 (1.24%)  
Dizziness † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Headache † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Hepatic encephalopathy † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Ischaemic cerebral infarction † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Neurotoxicity † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Syncope † 1    
# participants affected / at risk     1/421 (0.24%)     2/402 (0.50%)  
Ataxia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Cognitive disorder † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Depressed level of consciousness † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hemiparesis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hypoglycaemic coma † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Lethargy † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Optic neuritis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Presyncope † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Transient ischaemic attack † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Psychiatric disorders      
Mental status changes † 1    
# participants affected / at risk     2/421 (0.48%)     2/402 (0.50%)  
Confusional state † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Depression † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Hallucination † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Suicidal ideation † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Anxiety † 1    
# participants affected / at risk     0/421 (0.00%)     2/402 (0.50%)  
Biopolar I disorder † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Delirium † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Renal and urinary disorders      
Renal Failure † 1    
# participants affected / at risk     2/421 (0.48%)     3/402 (0.75%)  
Renal failure acute † 1    
# participants affected / at risk     2/421 (0.48%)     4/402 (1.00%)  
Renal colic † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Ureteric obstruction † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Haematuria † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Respiratory, thoracic and mediastinal disorders      
Pulmonary embolism † 1    
# participants affected / at risk     13/421 (3.09%)     20/402 (4.98%)  
Pleural effusion † 1    
# participants affected / at risk     7/421 (1.66%)     5/402 (1.24%)  
Dyspnoea † 1    
# participants affected / at risk     5/421 (1.19%)     2/402 (0.50%)  
Interstitial lung disease † 1    
# participants affected / at risk     4/421 (0.95%)     2/402 (0.50%)  
Pneumonitis † 1    
# participants affected / at risk     4/421 (0.95%)     1/402 (0.25%)  
Acute respiratory distress syndrome † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Diffuse alveolar damage † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Epistaxis † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Pulmonary alveolar haemorrhage † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Acute respiratory failure † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Hypoxia † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Pneumothorax † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Skin and subcutaneous tissue disorders      
Erythema † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Rash maculo-papular † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     9/421 (2.14%)     12/402 (2.99%)  
Capilary leak syndrome † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Hypotension † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Labile hypertension † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Malignant hypertension † 1    
# participants affected / at risk     1/421 (0.24%)     0/402 (0.00%)  
Thrombosis † 1    
# participants affected / at risk     1/421 (0.24%)     1/402 (0.25%)  
Arterial thrombosis limb † 1    
# participants affected / at risk     0/421 (0.00%)     2/402 (0.50%)  
Hypovolaemic shock † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Lymphoedema † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Orthostatic hypotension † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Phlebitis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Subclavian vein thrombosis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Venous stenosis † 1    
# participants affected / at risk     0/421 (0.00%)     1/402 (0.25%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 15.0




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anne McClain
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


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Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00844649     History of Changes
Other Study ID Numbers: CA046
Study First Received: February 13, 2009
Results First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Italy: The Italian Medicines Agency
Canada: Health Canada
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Australia: Department of Health and Ageing Therapeutic Goods Administration