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Trial record 54 of 371 for:    LENALIDOMIDE AND Dexamethasone

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00056160
Recruitment Status : Completed
First Posted : March 7, 2003
Results First Posted : March 3, 2010
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: CC-5013
Drug: Dexamethasone
Enrollment 353
Recruitment Details Subjects in the Placebo/Dex treatment group did not continue participation beyond the period "Up To Unblinding (07 Jun 2005"). Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)".
Pre-assignment Details Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)". Data for the period "Extended Follow-up Cutoff (23 Jul 2008)" subsumes data for the period "Up To Unblinding (07 Jun 2005)".
Arm/Group Title CC-5013/Dex Placebo/Dex
Hide Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Period Title: Up to Unblinding (07 Jun 2005)
Started 177 176
Completed 64 13
Not Completed 113 163
Reason Not Completed
Adverse Event             35             18
Progression of disease             57             124
Lack of Efficacy             3             5
Withdrawal by Subject             8             8
Death             2             1
Not specified             8             7
Period Title: Extended Follow-up Cutoff (23 Jul 2008)
Started 177 0
Completed 6 0
Not Completed 171 0
Reason Not Completed
Adverse Event             44             0
Progression of disease             87             0
Lack of Efficacy             3             0
Withdrawal by Subject             11             0
Death             5             0
Not specified             21             0
Period Title: Final Follow-up
Started 6 0
Completed 0 0
Not Completed 6 0
Reason Not Completed
Transferred into expanded access study.             3             0
Transferred into RevAssist Program             2             0
Adverse Event             1             0
Arm/Group Title CC-5013/Dex Placebo/Dex Total
Hide Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone Total of all reporting groups
Overall Number of Baseline Participants 177 176 353
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
94
  53.1%
103
  58.5%
197
  55.8%
>=65 years
83
  46.9%
73
  41.5%
156
  44.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 176 participants 353 participants
63.3  (9.84) 62.5  (9.81) 62.9  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
Female
71
  40.1%
72
  40.9%
143
  40.5%
Male
106
  59.9%
104
  59.1%
210
  59.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 176 participants 353 participants
United States 142 150 292
Canada 35 26 61
1.Primary Outcome
Title Time to Tumor Progression (TTP)
Hide Description Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Time Frame 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
Arm/Group Title CC-5013/Dex Placebo/Dex
Hide Arm/Group Description:
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Overall Number of Participants Analyzed 177 176
Median (95% Confidence Interval)
Unit of Measure: Weeks
60.1
(41.1 to 80.0)
20.1
(16.1 to 21.1)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was calculated as the time from randomization to death from any cause.
Time Frame 170 weeks (median overall survival of CC-5013/Dex treatment group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
Arm/Group Title CC-5013/Dex Placebo/Dex
Hide Arm/Group Description:
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Overall Number of Participants Analyzed 177 176
Median (95% Confidence Interval)
Unit of Measure: Weeks
170.1
(142.1 to 204.9)
136.4
(104.1 to 176.9)
3.Secondary Outcome
Title Myeloma Response
Hide Description The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
Time Frame Up to Unblinding (07 Jun 2005)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.
Arm/Group Title CC-5013/Dex Placebo/Dex
Hide Arm/Group Description:
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Overall Number of Participants Analyzed 177 176
Measure Type: Number
Unit of Measure: Participants
107 34
4.Secondary Outcome
Title Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
Hide Description The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
Time Frame 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
Arm/Group Title CC-5013/Dex Placebo/Dex
Hide Arm/Group Description:
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Overall Number of Participants Analyzed 177 176
Mean (Standard Deviation)
Unit of Measure: Weeks
29.9  (30.02) 15.0  (16.98)
Time Frame Up to 254 weeks (median=48 weeks; mean=77 weeks)
Adverse Event Reporting Description Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.
 
Arm/Group Title CC-5013/Dex Placebo/Dex
Hide Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
All-Cause Mortality
CC-5013/Dex Placebo/Dex
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CC-5013/Dex Placebo/Dex
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   111/177 (62.71%)      90/175 (51.43%)    
Blood and lymphatic system disorders     
ANAEMIA  1  2/177 (1.13%)  3 3/175 (1.71%)  3
FEBRILE NEUTROPENIA  1  5/177 (2.82%)  5 0/175 (0.00%)  0
HYPERVISCOSITY SYNDROME  1  0/177 (0.00%)  0 1/175 (0.57%)  1
LYMPHADENOPATHY  1  1/177 (0.56%)  1 0/175 (0.00%)  0
NEUTROPENIA  1  4/177 (2.26%)  4 1/175 (0.57%)  1
PANCYTOPENIA  1  2/177 (1.13%)  2 0/175 (0.00%)  0
THROMBOCYTOPENIA  1  3/177 (1.69%)  3 2/175 (1.14%)  2
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  3/177 (1.69%)  3 0/175 (0.00%)  0
ANGINA PECTORIS  1  2/177 (1.13%)  2 0/175 (0.00%)  0
ARTERIOSPASM CORONARY  1  1/177 (0.56%)  1 0/175 (0.00%)  0
ATRIAL FIBRILLATION  1  10/177 (5.65%)  11 1/175 (0.57%)  1
ATRIAL FLUTTER  1  2/177 (1.13%)  2 0/175 (0.00%)  0
CARDIAC ARREST  1  0/177 (0.00%)  0 1/175 (0.57%)  1
CARDIAC FAILURE CONGESTIVE  1  4/177 (2.26%)  4 0/175 (0.00%)  0
CARDIO-RESPIRATORY ARREST  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CORONARY ARTERY DISEASE  1  3/177 (1.69%)  3 0/175 (0.00%)  0
MYOCARDIAL INFARCTION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
PULMONARY OEDEMA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
SINUS TACHYCARDIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
TACHYCARDIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Endocrine disorders     
ADRENAL INSUFFICIENCY  1  2/177 (1.13%)  3 0/175 (0.00%)  0
Eye disorders     
BLINDNESS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
BLINDNESS TRANSIENT  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CATARACT UNILATERAL  1  0/177 (0.00%)  0 1/175 (0.57%)  1
RETINAL DETACHMENT  1  1/177 (0.56%)  1 0/175 (0.00%)  0
RETINAL VEIN OCCLUSION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  3/177 (1.69%)  4 1/175 (0.57%)  1
APPENDICITIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
COLITIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
COLITIS PSEUDOMEMBRANOUS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
CONSTIPATION  1  2/177 (1.13%)  2 0/175 (0.00%)  0
DIARRHOEA  1  4/177 (2.26%)  4 0/175 (0.00%)  0
DIVERTICULAR PERFORATION  1  0/177 (0.00%)  0 1/175 (0.57%)  1
DIVERTICULITIS  1  1/177 (0.56%)  1 1/175 (0.57%)  1
DIVERTICULUM INTESTINAL HAEMORRHAGIC  1  0/177 (0.00%)  0 1/175 (0.57%)  1
GASTRITIS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
GASTROENTERITIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
GINGIVAL BLEEDING  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HAEMORRHOIDAL HAEMORRHAGE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
INGUINAL HERNIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
INTESTINAL ISCHAEMIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
LARGE INTESTINAL PERFORATION  1  0/177 (0.00%)  0 1/175 (0.57%)  1
LOWER GASTROINTESTINAL HAEMORRHAGE  1  1/177 (0.56%)  1 0/175 (0.00%)  0
NAUSEA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
SMALL INTESTINAL OBSTRUCTION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
VOMITING  1  1/177 (0.56%)  1 1/175 (0.57%)  1
General disorders     
ASTHENIA  1  2/177 (1.13%)  2 0/175 (0.00%)  0
CATHETER SITE PAIN  1  0/177 (0.00%)  0 1/175 (0.57%)  1
CHEST PAIN  1  2/177 (1.13%)  2 0/175 (0.00%)  0
FATIGUE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
OEDEMA PERIPHERAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
PYREXIA  1  7/177 (3.95%)  8 6/175 (3.43%)  8
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Hepatobiliary disorders     
HEPATIC FAILURE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
HEPATITIS TOXIC  1  0/177 (0.00%)  0 1/175 (0.57%)  1
Infections and infestations     
ABSCESS INTESTINAL  1  0/177 (0.00%)  0 1/175 (0.57%)  1
ABSCESS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
ANAL INFECTION  1  0/177 (0.00%)  0 1/175 (0.57%)  1
APPENDICEAL ABSCESS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
ARTHRITIS BACTERIAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CATHETER RELATED INFECTION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CELLULITIS  1  2/177 (1.13%)  2 0/175 (0.00%)  0
CELLULITIS STAPHYLOCOCCAL  1  0/177 (0.00%)  0 1/175 (0.57%)  1
CLOSTRIDIUM COLITIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
ENCEPHALITIS HERPES  1  0/177 (0.00%)  0 1/175 (0.57%)  1
ENTEROBACTER BACTERAEMIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HERPES VIRAL INFECTION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HERPES ZOSTER  1  1/177 (0.56%)  1 0/175 (0.00%)  0
INFECTION  1  2/177 (1.13%)  2 1/175 (0.57%)  1
INTERSTITIAL PNEUMONIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
LOBAR PNEUMONIA  1  4/177 (2.26%)  6 1/175 (0.57%)  1
NEUTROPENIC SEPSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
OSTEOMYELITIS  1  1/177 (0.56%)  1 1/175 (0.57%)  1
PNEUMOCOCCAL BACTERAEMIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
PNEUMOCYSTIS CARINII PNEUMONIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
PNEUMONIA BACTERIAL  1  1/177 (0.56%)  1 1/175 (0.57%)  1
PNEUMONIA CYTOMEGALOVIRAL  1  0/177 (0.00%)  0 1/175 (0.57%)  1
PNEUMONIA FUNGAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
PNEUMONIA  1  30/177 (16.95%)  39 15/175 (8.57%)  17
PNEUMONIA PRIMARY ATYPICAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
PNEUMONIA STAPHYLOCOCCAL  1  0/177 (0.00%)  0 1/175 (0.57%)  1
PNEUMONIA STREPTOCOCCAL  1  0/177 (0.00%)  0 1/175 (0.57%)  1
SEPSIS  1  3/177 (1.69%)  3 2/175 (1.14%)  2
SINUSITIS FUNGAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SINUSITIS  1  2/177 (1.13%)  2 0/175 (0.00%)  0
STAPHYLOCOCCAL SEPSIS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
STREPTOCOCCAL BACTERAEMIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
STREPTOCOCCAL SEPSIS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
SUBACUTE ENDOCARDITIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
TOOTH ABSCESS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  2/177 (1.13%)  2 1/175 (0.57%)  1
URINARY TRACT INFECTION  1  4/177 (2.26%)  5 0/175 (0.00%)  0
UROSEPSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
VIRAL INFECTION  1  0/177 (0.00%)  0 1/175 (0.57%)  1
Injury, poisoning and procedural complications     
ACETABULUM FRACTURE  1  1/177 (0.56%)  1 0/175 (0.00%)  0
FEMUR FRACTURE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
FIBULA FRACTURE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
HIP FRACTURE  1  1/177 (0.56%)  1 1/175 (0.57%)  1
MULTIPLE FRACTURES  1  1/177 (0.56%)  1 0/175 (0.00%)  0
RADIUS FRACTURE  1  1/177 (0.56%)  1 0/175 (0.00%)  0
RIB FRACTURE  1  2/177 (1.13%)  2 1/175 (0.57%)  1
SPINAL COMPRESSION FRACTURE  1  1/177 (0.56%)  1 2/175 (1.14%)  2
VASCULAR GRAFT OCCLUSION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
WRIST FRACTURE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
Investigations     
BLOOD BILIRUBIN ABNORMAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
BLOOD CREATININE INCREASED  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HAEMOGLOBIN DECREASED  1  1/177 (0.56%)  1 0/175 (0.00%)  0
INTERNATIONAL NORMALISED RATIO INCREASED  1  2/177 (1.13%)  2 0/175 (0.00%)  0
LIVER FUNCTION TESTS ABNORMAL  1  1/177 (0.56%)  1 0/175 (0.00%)  0
WHITE BLOOD CELL COUNT DECREASED  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Metabolism and nutrition disorders     
DEHYDRATION  1  7/177 (3.95%)  9 5/175 (2.86%)  5
DIABETES WITH HYPEROSMOLARITY  1  0/177 (0.00%)  0 2/175 (1.14%)  2
DIABETIC KETOACIDOSIS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
FLUID OVERLOAD  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HYPERAMMONAEMIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
HYPERCALCAEMIA  1  2/177 (1.13%)  2 5/175 (2.86%)  5
HYPERGLYCAEMIA  1  2/177 (1.13%)  2 4/175 (2.29%)  4
HYPERKALAEMIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HYPOALBUMINAEMIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
HYPOCALCAEMIA  1  2/177 (1.13%)  2 1/175 (0.57%)  1
HYPOGLYCAEMIA  1  2/177 (1.13%)  4 0/175 (0.00%)  0
HYPOKALAEMIA  1  2/177 (1.13%)  2 1/175 (0.57%)  1
HYPOMAGNESAEMIA  1  2/177 (1.13%)  2 0/175 (0.00%)  0
METABOLIC ACIDOSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
BONE PAIN  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CHEST WALL PAIN  1  1/177 (0.56%)  1 0/175 (0.00%)  0
MUSCLE WEAKNESS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
MYALGIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
MYOPATHY STEROID  1  0/177 (0.00%)  0 2/175 (1.14%)  2
OSTEONECROSIS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BRONCHIOLOALVEOLAR CARCINOMA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
LEUKAEMIA PLASMACYTIC  1  0/177 (0.00%)  0 2/175 (1.14%)  2
LUNG NODULE  1  0/177 (0.00%)  0 1/175 (0.57%)  1
METASTASES TO LIVER  1  2/177 (1.13%)  2 0/175 (0.00%)  0
MYELODYSPLASTIC SYNDROME  1  2/177 (1.13%)  2 0/175 (0.00%)  0
PLASMACYTOMA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
SQUAMOUS CELL CARCINOMA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SQUAMOUS CELL CARCINOMA OF SKIN  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Nervous system disorders     
CEREBELLAR INFARCTION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CEREBRAL INFARCTION  1  0/177 (0.00%)  0 1/175 (0.57%)  1
CEREBRAL ISCHAEMIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CEREBROVASCULAR ACCIDENT  1  5/177 (2.82%)  5 1/175 (0.57%)  1
CONVULSIONS  1  0/177 (0.00%)  0 3/175 (1.71%)  3
DEPRESSED LEVEL OF CONSCIOUSNESS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
DIZZINESS  1  2/177 (1.13%)  2 0/175 (0.00%)  0
INTRACRANIAL HAEMORRHAGE  1  1/177 (0.56%)  1 0/175 (0.00%)  0
INTRACRANIAL VENOUS SINUS THROMBOSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
LEUKOENCEPHALOPATHY  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SOMNOLENCE  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SPINAL CORD COMPRESSION  1  0/177 (0.00%)  0 2/175 (1.14%)  2
SUBDURAL HAEMATOMA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SYNCOPE  1  3/177 (1.69%)  4 1/175 (0.57%)  1
TRANSIENT ISCHAEMIC ATTACK  1  1/177 (0.56%)  1 1/175 (0.57%)  1
Psychiatric disorders     
ANXIETY  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CONFUSIONAL STATE  1  1/177 (0.56%)  1 1/175 (0.57%)  1
DELIRIUM  1  1/177 (0.56%)  1 0/175 (0.00%)  0
DELUSION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
MAJOR DEPRESSIVE DISORDER  1  1/177 (0.56%)  1 0/175 (0.00%)  0
MENTAL STATUS CHANGES  1  1/177 (0.56%)  1 3/175 (1.71%)  3
PSYCHOTIC DISORDER  1  0/177 (0.00%)  0 2/175 (1.14%)  2
SUICIDE ATTEMPT  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Renal and urinary disorders     
AZOTAEMIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
FANCONI SYNDROME ACQUIRED  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HAEMATURIA  1  1/177 (0.56%)  1 1/175 (0.57%)  1
RENAL FAILURE ACUTE  1  3/177 (1.69%)  3 2/175 (1.14%)  2
RENAL FAILURE  1  3/177 (1.69%)  3 5/175 (2.86%)  5
RENAL TUBULAR NECROSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ACQUIRED BRONCHOMALACIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
BRONCHITIS  1  1/177 (0.56%)  1 1/175 (0.57%)  1
BRONCHOSPASM  1  1/177 (0.56%)  1 0/175 (0.00%)  0
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  1/177 (0.56%)  1 2/175 (1.14%)  2
COUGH  1  0/177 (0.00%)  0 1/175 (0.57%)  1
DYSPNOEA EXACERBATED  1  0/177 (0.00%)  0 1/175 (0.57%)  1
DYSPNOEA  1  4/177 (2.26%)  4 1/175 (0.57%)  1
EMPHYSEMATOUS BULLA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
EPISTAXIS  1  1/177 (0.56%)  1 1/175 (0.57%)  1
HYPOXIA  1  2/177 (1.13%)  24 1/175 (0.57%)  1
PLEURAL EFFUSION  1  1/177 (0.56%)  1 1/175 (0.57%)  1
PULMONARY EMBOLISM  1  6/177 (3.39%)  6 1/175 (0.57%)  1
RESPIRATORY FAILURE  1  1/177 (0.56%)  1 2/175 (1.14%)  2
Skin and subcutaneous tissue disorders     
DERMATITIS  1  0/177 (0.00%)  0 1/175 (0.57%)  1
RASH  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SKIN DESQUAMATION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
SKIN DISCOLOURATION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Vascular disorders     
AORTIC STENOSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
ARTERIAL THROMBOSIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
DEEP VEIN THROMBOSIS  1  18/177 (10.17%)  18 6/175 (3.43%)  6
HYPERTENSION  1  1/177 (0.56%)  1 1/175 (0.57%)  1
HYPERTENSIVE CRISIS  1  1/177 (0.56%)  1 0/175 (0.00%)  0
HYPOTENSION  1  0/177 (0.00%)  0 2/175 (1.14%)  2
ORTHOSTATIC HYPOTENSION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
PERIPHERAL ISCHAEMIA  1  1/177 (0.56%)  1 0/175 (0.00%)  0
PERIPHERAL ISCHAEMIA  1  0/177 (0.00%)  0 1/175 (0.57%)  1
SUPERIOR VENA CAVAL OCCLUSION  1  1/177 (0.56%)  1 0/175 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CC-5013/Dex Placebo/Dex
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   177/177 (100.00%)      175/175 (100.00%)    
Blood and lymphatic system disorders     
ANAEMIA  1  72/177 (40.68%)  139 37/175 (21.14%)  44
LEUKOPENIA  1  15/177 (8.47%)  20 3/175 (1.71%)  3
NEUTROPENIA  1  87/177 (49.15%)  348 12/175 (6.86%)  22
THROMBOCYTOPENIA  1  45/177 (25.42%)  83 19/175 (10.86%)  28
Endocrine disorders     
CUSHINGOID  1  12/177 (6.78%)  13 13/175 (7.43%)  13
Eye disorders     
CATARACT  1  9/177 (5.08%)  10 1/175 (0.57%)  1
CATARACT UNILATERAL  1  10/177 (5.65%)  15 2/175 (1.14%)  3
VISION BLURRED  1  50/177 (28.25%)  79 30/175 (17.14%)  56
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  11/177 (6.21%)  12 15/175 (8.57%)  18
ABDOMINAL PAIN  1  20/177 (11.30%)  27 12/175 (6.86%)  15
ABDOMINAL PAIN UPPER  1  11/177 (6.21%)  13 10/175 (5.71%)  12
CONSTIPATION  1  74/177 (41.81%)  99 35/175 (20.00%)  43
DIARRHOEA  1  85/177 (48.02%)  174 53/175 (30.29%)  85
DRY MOUTH  1  17/177 (9.60%)  18 8/175 (4.57%)  10
DYSPEPSIA  1  37/177 (20.90%)  41 28/175 (16.00%)  37
FLATULENCE  1  16/177 (9.04%)  18 9/175 (5.14%)  10
GASTROOESOPHAGEAL REFLUX DISEASE  1  10/177 (5.65%)  13 4/175 (2.29%)  5
LOOSE STOOLS  1  13/177 (7.34%)  14 10/175 (5.71%)  13
NAUSEA  1  58/177 (32.77%)  90 55/175 (31.43%)  79
ORAL PAIN  1  10/177 (5.65%)  12 1/175 (0.57%)  1
STOMATITIS  1  15/177 (8.47%)  23 14/175 (8.00%)  15
TOOTHACHE  1  10/177 (5.65%)  11 5/175 (2.86%)  5
VOMITING  1  26/177 (14.69%)  32 22/175 (12.57%)  24
General disorders     
ASTHENIA  1  43/177 (24.29%)  59 47/175 (26.86%)  66
CHEST PAIN  1  22/177 (12.43%)  34 15/175 (8.57%)  24
FATIGUE  1  114/177 (64.41%)  191 105/175 (60.00%)  164
INFLUENZA LIKE ILLNESS  1  10/177 (5.65%)  11 3/175 (1.71%)  5
LETHARGY  1  11/177 (6.21%)  12 4/175 (2.29%)  4
OEDEMA  1  15/177 (8.47%)  22 18/175 (10.29%)  22
OEDEMA PERIPHERAL  1  58/177 (32.77%)  87 42/175 (24.00%)  54
PAIN  1  20/177 (11.30%)  23 19/175 (10.86%)  25
PYREXIA  1  54/177 (30.51%)  85 35/175 (20.00%)  48
RIGORS  1  10/177 (5.65%)  15 14/175 (8.00%)  16
Infections and infestations     
CELLULITIS  1  10/177 (5.65%)  11 3/175 (1.71%)  3
HERPES SIMPLEX  1  15/177 (8.47%)  22 6/175 (3.43%)  6
ORAL CANDIDIASIS  1  14/177 (7.91%)  18 10/175 (5.71%)  11
PNEUMONIA  1  23/177 (12.99%)  31 4/175 (2.29%)  4
SINUSITIS  1  26/177 (14.69%)  41 11/175 (6.29%)  14
URINARY TRACT INFECTION  1  18/177 (10.17%)  31 7/175 (4.00%)  13
Investigations     
BLOOD CREATININE INCREASED  1  9/177 (5.08%)  13 6/175 (3.43%)  6
LIVER FUNCTION TESTS ABNORMAL  1  10/177 (5.65%)  11 3/175 (1.71%)  3
WEIGHT DECREASED  1  20/177 (11.30%)  24 8/175 (4.57%)  8
Metabolism and nutrition disorders     
ANOREXIA  1  35/177 (19.77%)  39 22/175 (12.57%)  23
APPETITE DECREASED  1  21/177 (11.86%)  25 12/175 (6.86%)  14
DEHYDRATION  1  21/177 (11.86%)  26 9/175 (5.14%)  10
FLUID RETENTION  1  9/177 (5.08%)  9 2/175 (1.14%)  3
HYPERGLYCAEMIA  1  37/177 (20.90%)  62 24/175 (13.71%)  28
HYPERKALAEMIA  1  10/177 (5.65%)  11 2/175 (1.14%)  2
HYPOCALCAEMIA  1  17/177 (9.60%)  22 4/175 (2.29%)  5
HYPOKALAEMIA  1  34/177 (19.21%)  91 12/175 (6.86%)  17
HYPOMAGNESAEMIA  1  21/177 (11.86%)  34 8/175 (4.57%)  8
HYPOPHOSPHATAEMIA  1  9/177 (5.08%)  11 5/175 (2.86%)  5
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  41/177 (23.16%)  63 35/175 (20.00%)  51
BACK PAIN  1  57/177 (32.20%)  71 38/175 (21.71%)  40
BONE PAIN  1  20/177 (11.30%)  31 15/175 (8.57%)  25
CHEST WALL PAIN  1  17/177 (9.60%)  18 9/175 (5.14%)  9
JOINT SWELLING  1  9/177 (5.08%)  11 2/175 (1.14%)  2
MUSCLE CRAMP  1  69/177 (38.98%)  120 41/175 (23.43%)  61
MUSCLE SPASMS  1  9/177 (5.08%)  11 5/175 (2.86%)  6
MUSCLE WEAKNESS  1  27/177 (15.25%)  37 29/175 (16.57%)  31
MUSCULOSKELETAL STIFFNESS  1  9/177 (5.08%)  9 6/175 (3.43%)  7
MYALGIA  1  21/177 (11.86%)  22 22/175 (12.57%)  26
PAIN IN LIMB  1  28/177 (15.82%)  38 13/175 (7.43%)  23
PERIPHERAL SWELLING  1  18/177 (10.17%)  21 4/175 (2.29%)  5
Nervous system disorders     
AGEUSIA  1  10/177 (5.65%)  13 7/175 (4.00%)  7
BALANCE IMPAIRED  1  10/177 (5.65%)  11 3/175 (1.71%)  3
DIZZINESS  1  51/177 (28.81%)  102 43/175 (24.57%)  54
DYSGEUSIA  1  34/177 (19.21%)  37 19/175 (10.86%)  23
HEADACHE  1  56/177 (31.64%)  79 54/175 (30.86%)  66
HYPERTENSION  1  17/177 (9.60%)  17 11/175 (6.29%)  15
NEUROPATHY  1  21/177 (11.86%)  25 12/175 (6.86%)  13
PARAESTHESIA  1  24/177 (13.56%)  31 18/175 (10.29%)  23
PERIPHERAL NEUROPATHY  1  27/177 (15.25%)  33 19/175 (10.86%)  23
SOMNOLENCE  1  10/177 (5.65%)  10 7/175 (4.00%)  8
SYNCOPE  1  9/177 (5.08%)  16 1/175 (0.57%)  1
TREMOR  1  36/177 (20.34%)  44 12/175 (6.86%)  15
Psychiatric disorders     
ANXIETY  1  32/177 (18.08%)  38 20/175 (11.43%)  22
CONFUSIONAL STATE  1  22/177 (12.43%)  25 14/175 (8.00%)  16
DEPRESSION  1  29/177 (16.38%)  31 19/175 (10.86%)  19
INSOMNIA  1  84/177 (47.46%)  99 70/175 (40.00%)  84
IRRITABILITY  1  20/177 (11.30%)  21 11/175 (6.29%)  11
MOOD ALTERATION  1  5/177 (2.82%)  6 17/175 (9.71%)  17
MOOD SWINGS  1  9/177 (5.08%)  9 4/175 (2.29%)  4
Renal and urinary disorders     
NOCTURIA  1  6/177 (3.39%)  6 10/175 (5.71%)  11
URINARY FREQUENCY  1  11/177 (6.21%)  13 7/175 (4.00%)  8
Respiratory, thoracic and mediastinal disorders     
BRONCHITIS  1  19/177 (10.73%)  24 3/175 (1.71%)  7
COUGH  1  53/177 (29.94%)  91 48/175 (27.43%)  53
DYSPNOEA EXERTIONAL  1  14/177 (7.91%)  16 12/175 (6.86%)  12
DYSPNOEA  1  51/177 (28.81%)  64 39/175 (22.29%)  47
EPISTAXIS  1  16/177 (9.04%)  21 11/175 (6.29%)  12
HICCUPS  1  11/177 (6.21%)  26 9/175 (5.14%)  9
HOARSENESS  1  19/177 (10.73%)  20 14/175 (8.00%)  14
NASAL CONGESTION  1  20/177 (11.30%)  20 7/175 (4.00%)  8
NASOPHARYNGITIS  1  39/177 (22.03%)  82 11/175 (6.29%)  13
PHARYNGITIS  1  33/177 (18.64%)  55 18/175 (10.29%)  22
PRODUCTIVE COUGH  1  12/177 (6.78%)  13 7/175 (4.00%)  7
RHINORRHOEA  1  9/177 (5.08%)  12 5/175 (2.86%)  6
UPPER RESPIRATORY TRACT INFECTION  1  63/177 (35.59%)  123 39/175 (22.29%)  59
Skin and subcutaneous tissue disorders     
CONTUSION  1  20/177 (11.30%)  23 13/175 (7.43%)  15
DRY SKIN  1  19/177 (10.73%)  24 10/175 (5.71%)  13
ECCHYMOSIS  1  9/177 (5.08%)  9 1/175 (0.57%)  1
ERYTHEMA  1  10/177 (5.65%)  12 6/175 (3.43%)  6
FACE OEDEMA  1  13/177 (7.34%)  15 13/175 (7.43%)  13
NIGHT SWEATS  1  16/177 (9.04%)  20 13/175 (7.43%)  16
PRURITUS  1  20/177 (11.30%)  30 10/175 (5.71%)  11
RASH  1  55/177 (31.07%)  83 28/175 (16.00%)  30
SWEATING INCREASED  1  19/177 (10.73%)  21 10/175 (5.71%)  11
Vascular disorders     
DEEP VEIN THROMBOSIS  1  10/177 (5.65%)  10 0/175 (0.00%)  0
FLUSHING  1  12/177 (6.78%)  13 12/175 (6.86%)  12
HYPOTENSION  1  20/177 (11.30%)  21 5/175 (2.86%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.
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 investigator shall have the right to publish and/or present the clinical data generated from the study provided that such Investigator shall furnish sponsor with a copy of the proposed publication or presentation at least 60 days in advance of submission, delete any confidential information, and delay submission for up to 90 days to permit the preparation and filing of appropriate intellectual property applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Knight, M.D.
Organization: Celgene Corporation
Phone: 908-673-9749
EMail: rknight@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00056160     History of Changes
Other Study ID Numbers: CC-5013-MM-009
First Submitted: March 6, 2003
First Posted: March 7, 2003
Results First Submitted: December 24, 2009
Results First Posted: March 3, 2010
Last Update Posted: October 19, 2017