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Trial record 11 of 371 for:    LENALIDOMIDE AND Dexamethasone

Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00179647
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : March 3, 2010
Last Update Posted : March 16, 2010
Sponsor:
Collaborator:
Prologue Research International
Information provided by:
Celgene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: lenalidomide
Drug: dexamethasone
Enrollment 1913
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
Period Title: Overall Study
Started 1913
Completed 0 [1]
Not Completed 1913
Reason Not Completed
Adverse Event             294
Lack of Efficacy             478
Withdrawal by Subject             83
Lost to Follow-up             4
Death             94
Not specified             960
[1]
Subjects participated in study until they presented with reason for discontinuation.
Arm/Group Title Lenalidomide
Hide Arm/Group Description This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
Overall Number of Baseline Participants 1913
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1913 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1090
  57.0%
>=65 years
823
  43.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1913 participants
63.4  (10.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1913 participants
Female
762
  39.8%
Male
1151
  60.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1913 participants
United States 1183
Canada 730
1.Primary Outcome
Title Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.
Hide Description Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Time Frame Median time-on-study=18.3 weeks
Outcome Measure Data Not Reported
2.Primary Outcome
Title Overall Incidence of Adverse Events
Hide Description Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Time Frame Median time-on-study=18.3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received study drug
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
Overall Number of Participants Analyzed 1913
Measure Type: Number
Unit of Measure: Participants
1877
Time Frame Median time-on-study=18.3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%) # Events
Total   878/1913 (45.90%)    
Blood and lymphatic system disorders   
ANEMIA  1  68/1913 (3.55%)  75
DISSEMINATED INTRAVASCULAR COAGULATION  1  1/1913 (0.05%)  1
FEBRILE NEUTROPENIA  1  64/1913 (3.35%)  75
HYPERVISCOSITY SYNDROME  1  1/1913 (0.05%)  1
LEUKOPENIA  1  6/1913 (0.31%)  6
LYMPHOPENIA  1  1/1913 (0.05%)  2
NEUTROPENIA  1  45/1913 (2.35%)  46
PANCYTOPENIA  1  31/1913 (1.62%)  31
THROMBOCYTOPENIA  1  79/1913 (4.13%)  92
Cardiac disorders   
ACUTE CORONARY SYNDROME  1  2/1913 (0.10%)  3
ACUTE MYOCARDIAL INFARCTION  1  2/1913 (0.10%)  2
ANGINA PECTORIS  1  6/1913 (0.31%)  7
ANGINA UNSTABLE  1  1/1913 (0.05%)  1
ARRHYTHMIA  1  2/1913 (0.10%)  2
ATRIAL FIBRILLATION  1  32/1913 (1.67%)  36
ATRIAL FLUTTER  1  4/1913 (0.21%)  4
BRADYCARDIA  1  3/1913 (0.16%)  3
CARDIAC AMYLOIDOSIS  1  1/1913 (0.05%)  1
CARDIAC ARREST  1  5/1913 (0.26%)  5
CARDIAC FAILURE  1  2/1913 (0.10%)  2
CARDIAC FAILURE CONGESTIVE  1  24/1913 (1.25%)  27
CARDIO-RESPIRATORY ARREST  1  4/1913 (0.21%)  4
CARDIOMYOPATHY  1  1/1913 (0.05%)  1
CARDIOPULMONARY FAILURE  1  1/1913 (0.05%)  1
CORONARY ARTERY DISEASE  1  3/1913 (0.16%)  3
CORONARY ARTERY INSUFFICIENCY  1  1/1913 (0.05%)  1
MYOCARDIAL INFARCTION  1  14/1913 (0.73%)  14
MYOCARDIAL ISCHAEMIA  1  1/1913 (0.05%)  1
PALPITATIONS  1  1/1913 (0.05%)  1
PERICARDITIS  1  1/1913 (0.05%)  1
PULMONARY OEDEMA  1  1/1913 (0.05%)  1
RIGHT VENTRICULAR FAILURE  1  2/1913 (0.10%)  2
SICK SINUS SYNDROME  1  3/1913 (0.16%)  3
SINUS TACHYCARDIA  1  2/1913 (0.10%)  2
TACHYCARDIA  1  2/1913 (0.10%)  2
VENTRICULAR TACHYCARDIA  1  2/1913 (0.10%)  2
Congenital, familial and genetic disorders   
ARTERIOVENOUS MALFORMATION  1  1/1913 (0.05%)  1
Ear and labyrinth disorders   
DEAFNESS NEUROSENSORY  1  1/1913 (0.05%)  1
DEAFNESS UNILATERAL  1  1/1913 (0.05%)  1
Endocrine disorders   
ADRENAL INSUFFICIENCY  1  3/1913 (0.16%)  3
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION  1  1/1913 (0.05%)  1
Eye disorders   
DIPLOPIA  1  1/1913 (0.05%)  1
HYALITIS  1  1/1913 (0.05%)  1
RETINAL VEIN THROMBOSIS  1  1/1913 (0.05%)  1
VISUAL DISTURBANCE  1  1/1913 (0.05%)  1
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/1913 (0.05%)  1
ABDOMINAL HAEMATOMA  1  1/1913 (0.05%)  1
ABDOMINAL PAIN  1  7/1913 (0.37%)  7
ABDOMINAL STRANGULATED HERNIA  1  1/1913 (0.05%)  1
ACUTE DIVERTICULITIS  1  2/1913 (0.10%)  2
APPENDICITIS  1  1/1913 (0.05%)  1
COLITIS  1  3/1913 (0.16%)  3
COLONIC FISTULA  1  1/1913 (0.05%)  1
COLONIC PERFORATION  1  1/1913 (0.05%)  1
CONSTIPATION  1  5/1913 (0.26%)  5
DIARRHOEA  1  18/1913 (0.94%)  18
DIVERTICULAR PERFORATION  1  3/1913 (0.16%)  3
DIVERTICULITIS  1  2/1913 (0.10%)  2
DUODENITIS  1  1/1913 (0.05%)  1
DYSPHAGIA  1  1/1913 (0.05%)  1
ENTERITIS  1  1/1913 (0.05%)  1
ENTEROCOLITIS  1  1/1913 (0.05%)  1
FAECAL INCONTINENCE  1  1/1913 (0.05%)  1
GASTRIC ULCER  1  1/1913 (0.05%)  1
GASTROENTERITIS  1  1/1913 (0.05%)  1
GASTROINTESTINAL HAEMORRHAGE  1  20/1913 (1.05%)  20
GASTROINTESTINAL NECROSIS  1  1/1913 (0.05%)  1
GASTROINTESTINAL PERFORATION  1  1/1913 (0.05%)  1
HAEMATOCHEZIA  1  1/1913 (0.05%)  1
ILEUS PARALYTIC  1  5/1913 (0.26%)  5
IMPAIRED GASTRIC EMPTYING  1  1/1913 (0.05%)  1
INFLUENZA  1  5/1913 (0.26%)  5
INTESTINAL MASS  1  1/1913 (0.05%)  1
INTESTINAL PERFORATION  1  1/1913 (0.05%)  1
INTRA-ABDOMINAL HAEMORRHAGE  1  1/1913 (0.05%)  1
LARGE INTESTINAL PERFORATION  1  1/1913 (0.05%)  1
MELAENA  1  1/1913 (0.05%)  2
MOUTH HAEMORRHAGE  1  1/1913 (0.05%)  1
NAUSEA  1  11/1913 (0.58%)  11
OESOPHAGITIS  1  1/1913 (0.05%)  1
PALATAL DISORDER  1  1/1913 (0.05%)  1
PANCREATITIS  1  5/1913 (0.26%)  5
PEPTIC ULCER  1  1/1913 (0.05%)  1
PEPTIC ULCER HAEMORRHAGE  1  2/1913 (0.10%)  2
RECTAL HAEMORRHAGE  1  3/1913 (0.16%)  3
RECTOVAGINAL FISTULA  1  1/1913 (0.05%)  1
RETROPERITONEAL HAEMORRHAGE  1  1/1913 (0.05%)  1
RUPTURED DIVERTICULUM  1  1/1913 (0.05%)  1
SMALL INTESTINAL OBSTRUCTION  1  3/1913 (0.16%)  3
STOMATITIS  1  2/1913 (0.10%)  2
UPPER GASTROINTESTINAL HAEMORRHAGE  1  2/1913 (0.10%)  2
VOMITING  1  16/1913 (0.84%)  16
General disorders   
ASTHENIA  1  35/1913 (1.83%)  36
CATHETER SITE CELLULITIS  1  1/1913 (0.05%)  1
CATHETER SITE HAEMORRHAGE  1  1/1913 (0.05%)  1
CHEST PAIN  1  9/1913 (0.47%)  9
DEATH  1  3/1913 (0.16%)  3
DIFFICULTY IN WALKING  1  1/1913 (0.05%)  1
DRUG WITHDRAWAL SYNDROME  1  1/1913 (0.05%)  1
FALL  1  7/1913 (0.37%)  7
FATIGUE  1  29/1913 (1.52%)  29
FEELING COLD  1  1/1913 (0.05%)  1
GAIT ABNORMAL  1  2/1913 (0.10%)  2
HERNIA  1  1/1913 (0.05%)  2
INJECTION SITE THROMBOSIS  1  1/1913 (0.05%)  1
INTRACTABLE PAIN  1  2/1913 (0.10%)  2
LETHARGY  1  4/1913 (0.21%)  4
MULTI-ORGAN FAILURE  1  5/1913 (0.26%)  5
OEDEMA  1  3/1913 (0.16%)  3
OEDEMA PERIPHERAL  1  2/1913 (0.10%)  2
ORGAN FAILURE  1  1/1913 (0.05%)  1
PAIN  1  14/1913 (0.73%)  16
PERFORMANCE STATUS DECREASED  1  1/1913 (0.05%)  1
PYREXIA  1  68/1913 (3.55%)  74
RIGORS  1  7/1913 (0.37%)  7
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  2/1913 (0.10%)  2
ULCER  1  1/1913 (0.05%)  1
Hepatobiliary disorders   
BILE DUCT STONE  1  1/1913 (0.05%)  1
CHOLANGITIS  1  2/1913 (0.10%)  2
CHOLECYSTITIS  1  3/1913 (0.16%)  3
CHOLELITHIASIS  1  2/1913 (0.10%)  2
HEPATIC FAILURE  1  1/1913 (0.05%)  1
HEPATITIS  1  1/1913 (0.05%)  1
HYPERBILIRUBINAEMIA  1  10/1913 (0.52%)  11
JAUNDICE  1  3/1913 (0.16%)  3
JAUNDICE CHOLESTATIC  1  1/1913 (0.05%)  1
Immune system disorders   
DRUG HYPERSENSITIVITY  1  1/1913 (0.05%)  1
GRAFT VERSUS HOST DISEASE  1  1/1913 (0.05%)  1
Infections and infestations   
ABDOMINAL ABSCESS  1  1/1913 (0.05%)  1
ARTHRITIS BACTERIAL  1  2/1913 (0.10%)  2
ARTHRITIS INFECTIVE  1  1/1913 (0.05%)  1
ASPERGILLOSIS  1  1/1913 (0.05%)  1
BACTERAEMIA  1  10/1913 (0.52%)  10
BACTERIAL INFECTION  1  1/1913 (0.05%)  1
BACTERIAL SEPSIS  1  2/1913 (0.10%)  2
BRONCHIECTASIS  1  1/1913 (0.05%)  1
BRONCHIOLITIS  1  1/1913 (0.05%)  1
BRONCHOPNEUMONIA  1  4/1913 (0.21%)  4
BRONCHOPULMONARY ASPERGILLOSIS  1  1/1913 (0.05%)  1
CANDIDA SEPSIS  1  1/1913 (0.05%)  1
CANDIDAL INFECTION  1  1/1913 (0.05%)  1
CATHETER SEPSIS  1  1/1913 (0.05%)  1
CELLULITIS  1  15/1913 (0.78%)  15
CENTRAL LINE INFECTION  1  3/1913 (0.16%)  4
CLOSTRIDIAL INFECTION  1  3/1913 (0.16%)  4
CLOSTRIDIUM COLITIS  1  10/1913 (0.52%)  10
ENDOCARDITIS INFECTIVE  1  1/1913 (0.05%)  1
ENTEROCOLITIS INFECTIOUS  1  4/1913 (0.21%)  4
EPIGLOTTITIS  1  2/1913 (0.10%)  2
ESCHERICHIA SEPSIS  1  2/1913 (0.10%)  2
ESCHERICHIA URINARY TRACT INFECTION  1  1/1913 (0.05%)  1
EYE INFECTION  1  1/1913 (0.05%)  1
FUNGAL INFECTION  1  1/1913 (0.05%)  1
FUNGAL SEPSIS  1  1/1913 (0.05%)  1
GASTROENTERITIS BACTERIAL  1  1/1913 (0.05%)  1
GASTROENTERITIS VIRAL  1  1/1913 (0.05%)  1
GRAM-POSITIVE BACTERIAL INFECTION  1  2/1913 (0.10%)  2
HERPES ZOSTER  1  7/1913 (0.37%)  7
INFECTION  1  19/1913 (0.99%)  19
INTERSTITIAL PNEUMONIA  1  1/1913 (0.05%)  1
LISTERIOSIS  1  3/1913 (0.16%)  3
LIVER FUNCTION TESTS ABNORMAL  1  5/1913 (0.26%)  5
LOBAR PNEUMONIA  1  12/1913 (0.63%)  13
LOCALISED INFECTION  1  5/1913 (0.26%)  6
LOWER RESPIRATORY TRACT INFECTION  1  4/1913 (0.21%)  4
LUNG ABSCESS  1  1/1913 (0.05%)  1
LUNG INFECTION  1  3/1913 (0.16%)  3
MENINGITIS  1  1/1913 (0.05%)  1
MENINGITIS PNEUMOCOCCAL  1  2/1913 (0.10%)  2
MUCORMYCOSIS  1  1/1913 (0.05%)  1
MYCOBACTERIUM AVIUM COMPLEX INFECTION  1  1/1913 (0.05%)  1
NECROTISING FASCIITIS  1  2/1913 (0.10%)  2
NEUTROPENIC SEPSIS  1  9/1913 (0.47%)  9
OPPORTUNISTIC INFECTION  1  2/1913 (0.10%)  2
ORAL CANDIDIASIS  1  1/1913 (0.05%)  1
ORAL INFECTION  1  1/1913 (0.05%)  1
OSTEOMYELITIS  1  1/1913 (0.05%)  1
PARAINFLUENZAE VIRUS INFECTION  1  2/1913 (0.10%)  2
PAROTITIS  1  1/1913 (0.05%)  1
PERITONSILLAR ABSCESS  1  1/1913 (0.05%)  1
PNEUMOCOCCAL BACTERAEMIA  1  1/1913 (0.05%)  1
PNEUMOCOCCAL SEPSIS  1  1/1913 (0.05%)  1
PNEUMOCYSTIS CARINII PNEUMONIA  1  3/1913 (0.16%)  3
PNEUMONIA  1  168/1913 (8.78%)  189
PNEUMONIA PNEUMOCOCCAL  1  1/1913 (0.05%)  1
PNEUMONIA PRIMARY ATYPICAL  1  1/1913 (0.05%)  1
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL  1  2/1913 (0.10%)  2
PNEUMONIA STAPHYLOCOCCAL  1  2/1913 (0.10%)  2
PNEUMONIA STREPTOCOCCAL  1  7/1913 (0.37%)  7
PNEUMONIA VIRAL  1  1/1913 (0.05%)  1
PSEUDOMONAL SEPSIS  1  1/1913 (0.05%)  1
PSOAS ABSCESS  1  1/1913 (0.05%)  1
RECTAL ABSCESS  1  1/1913 (0.05%)  1
RESPIRATORY SYNCYTIAL VIRUS INFECTION  1  1/1913 (0.05%)  1
RESPIRATORY TRACT INFECTION  1  8/1913 (0.42%)  8
SALMONELLA BACTERAEMIA  1  1/1913 (0.05%)  1
SEPSIS  1  39/1913 (2.04%)  39
SEPTIC SHOCK  1  17/1913 (0.89%)  17
SINUSITIS  1  3/1913 (0.16%)  3
SINUSITIS ACUTE  1  1/1913 (0.05%)  1
SKIN AND SUBCUTANEOUS TISSUE ABSCESS  1  1/1913 (0.05%)  1
STAPHYLOCOCCAL BACTERAEMIA  1  2/1913 (0.10%)  2
STAPHYLOCOCCAL INFECTION  1  2/1913 (0.10%)  2
STAPHYLOCOCCAL SEPSIS  1  3/1913 (0.16%)  3
STREPTOCOCCAL SEPSIS  1  1/1913 (0.05%)  1
TONSILLITIS ACUTE  1  1/1913 (0.05%)  1
UPPER RESPIRATORY TRACT INFECTION  1  10/1913 (0.52%)  10
URINARY TRACT INFECTION  1  22/1913 (1.15%)  22
URINARY TRACT INFECTION ENTEROCOCCAL  1  1/1913 (0.05%)  1
UROSEPSIS  1  5/1913 (0.26%)  5
VIRAL INFECTION  1  1/1913 (0.05%)  1
WOUND INFECTION  1  2/1913 (0.10%)  2
Injury, poisoning and procedural complications   
ANKLE FRACTURE  1  1/1913 (0.05%)  1
CERVICAL VERTEBRAL FRACTURE  1  1/1913 (0.05%)  1
COMPRESSION FRACTURE  1  2/1913 (0.10%)  2
FEMUR FRACTURE  1  3/1913 (0.16%)  3
FRACTURE  1  1/1913 (0.05%)  1
HIP FRACTURE  1  5/1913 (0.26%)  5
HUMERUS FRACTURE  1  4/1913 (0.21%)  5
MEDICATION ERROR  1  5/1913 (0.26%)  6
OVERDOSE  1  5/1913 (0.26%)  5
PAIN TRAUMA ACTIVATED  1  1/1913 (0.05%)  1
RADIATION OESOPHAGITIS  1  1/1913 (0.05%)  1
RIB FRACTURE  1  1/1913 (0.05%)  1
SPINAL COMPRESSION FRACTURE  1  6/1913 (0.31%)  6
SUBDURAL HAEMATOMA  1  1/1913 (0.05%)  1
THERAPEUTIC AGENT POISONING  1  1/1913 (0.05%)  1
THERMAL BURN  1  1/1913 (0.05%)  1
TIBIA FRACTURE  1  1/1913 (0.05%)  1
TRANSFUSION REACTION  1  1/1913 (0.05%)  1
UPPER LIMB FRACTURE  1  1/1913 (0.05%)  1
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  2/1913 (0.10%)  2
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/1913 (0.10%)  2
BLOOD AMYLASE INCREASED  1  1/1913 (0.05%)  1
BLOOD BILIRUBIN INCREASED  1  3/1913 (0.16%)  3
BLOOD CREATININE INCREASED  1  17/1913 (0.89%)  17
BLOOD GLUCOSE INCREASED  1  1/1913 (0.05%)  1
BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED  1  1/1913 (0.05%)  1
BLOOD UREA INCREASED  1  1/1913 (0.05%)  1
ELECTROCARDIOGRAM QT PROLONGED  1  1/1913 (0.05%)  1
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  1/1913 (0.05%)  2
HAEMATOCRIT DECREASED  1  1/1913 (0.05%)  1
HAEMOGLOBIN DECREASED  1  5/1913 (0.26%)  6
HEART RATE INCREASED  1  1/1913 (0.05%)  1
INTERNATIONAL NORMALISED RATIO INCREASED  1  2/1913 (0.10%)  2
NEUTROPHIL COUNT DECREASED  1  1/1913 (0.05%)  1
OXYGEN SATURATION DECREASED  1  2/1913 (0.10%)  2
PROTHROMBIN TIME PROLONGED  1  1/1913 (0.05%)  1
TRANSAMINASES INCREASED  1  1/1913 (0.05%)  1
TROPONIN  1  1/1913 (0.05%)  1
TROPONIN INCREASED  1  1/1913 (0.05%)  1
VENOUS PRESSURE JUGULAR INCREASED  1  1/1913 (0.05%)  1
WEIGHT DECREASED  1  2/1913 (0.10%)  2
WHITE BLOOD CELL COUNT DECREASED  1  2/1913 (0.10%)  2
Metabolism and nutrition disorders   
ANOREXIA  1  7/1913 (0.37%)  8
APPETITE DECREASED  1  2/1913 (0.10%)  2
CACHEXIA  1  2/1913 (0.10%)  2
DEHYDRATION  1  41/1913 (2.14%)  48
DIABETES MELLITUS  1  3/1913 (0.16%)  3
DIABETIC HYPEROSMOLAR NON-KETOACIDOSIS  1  1/1913 (0.05%)  1
DIABETIC KETOACIDOSIS  1  1/1913 (0.05%)  1
DYSLIPIDAEMIA  1  1/1913 (0.05%)  1
ELECTROLYTE IMBALANCE  1  4/1913 (0.21%)  7
FAILURE TO THRIVE  1  7/1913 (0.37%)  7
GOUT  1  1/1913 (0.05%)  1
HYPERCALCEMIA  1  16/1913 (0.84%)  16
HYPERGLYCAEMIA  1  19/1913 (0.99%)  19
HYPERKALEMIA  1  8/1913 (0.42%)  8
HYPERURICAEMIA  1  1/1913 (0.05%)  1
HYPOCALCAEMIA  1  6/1913 (0.31%)  7
HYPOGLYCAEMIA  1  2/1913 (0.10%)  2
HYPOKALEMIA  1  11/1913 (0.58%)  12
HYPONATRAEMIA  1  8/1913 (0.42%)  9
HYPOPHOSPHATAEMIA  1  1/1913 (0.05%)  1
METABOLIC ACIDOSIS  1  1/1913 (0.05%)  1
POLYDIPSIA  1  1/1913 (0.05%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  12/1913 (0.63%)  12
ARTHRITIS  1  1/1913 (0.05%)  1
ASEPTIC NECROSIS BONE  1  2/1913 (0.10%)  2
BACK PAIN  1  29/1913 (1.52%)  30
BONE LESION  1  1/1913 (0.05%)  1
BONE PAIN  1  5/1913 (0.26%)  6
CHEST WALL PAIN  1  7/1913 (0.37%)  8
CHONDROCALCINOSIS PYROPHOSPHATE  1  2/1913 (0.10%)  2
GROIN PAIN  1  1/1913 (0.05%)  1
JOINT EFFUSION  1  1/1913 (0.05%)  1
JOINT SWELLING  1  1/1913 (0.05%)  1
MUSCLE CRAMP  1  1/1913 (0.05%)  1
MUSCLE SPASMS  1  1/1913 (0.05%)  1
MUSCLE TWITCHING  1  1/1913 (0.05%)  1
MUSCLE WEAKNESS  1  7/1913 (0.37%)  8
MYOSITIS  1  2/1913 (0.10%)  2
NECK PAIN  1  2/1913 (0.10%)  2
PAIN IN LIMB  1  3/1913 (0.16%)  4
PATHOLOGICAL FRACTURE  1  5/1913 (0.26%)  5
PERIPHERAL SWELLING  1  1/1913 (0.05%)  1
RHABDOMYOLYSIS  1  1/1913 (0.05%)  1
SPONDYLOLISTHESIS ACQUIRED  1  1/1913 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
B-CELL LYMPHOMA  1  1/1913 (0.05%)  1
BREAST CANCER  1  4/1913 (0.21%)  4
GASTROINTESTINAL TRACT CANCER  1  1/1913 (0.05%)  1
LEUKAEMIA PLASMACYTIC  1  2/1913 (0.10%)  2
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED  1  1/1913 (0.05%)  1
MALIGNANT PLEURAL EFFUSION  1  1/1913 (0.05%)  1
METASTASES TO BRAIN  1  1/1913 (0.05%)  1
METASTASES TO SKIN  1  1/1913 (0.05%)  1
METASTATIC MALIGNANT MELANOMA  1  1/1913 (0.05%)  1
MULTIPLE MYELOMA  1  50/1913 (2.61%)  50
PANCREATIC CARCINOMA METASTATIC  1  1/1913 (0.05%)  1
PLASMACYTOMA  1  2/1913 (0.10%)  2
SQUAMOUS CELL CARCINOMA  1  2/1913 (0.10%)  2
SQUAMOUS CELL CARCINOMA OF SKIN  1  2/1913 (0.10%)  2
TUMOUR ASSOCIATED FEVER  1  2/1913 (0.10%)  2
Nervous system disorders   
ATAXIA  1  1/1913 (0.05%)  1
BRAIN OEDEMA  1  1/1913 (0.05%)  1
CEREBRAL HAEMATOMA  1  1/1913 (0.05%)  1
CEREBRAL HAEMORRHAGE  1  2/1913 (0.10%)  2
CEREBRAL ISCHAEMIA  1  3/1913 (0.16%)  3
CEREBROVASCULAR ACCIDENT  1  10/1913 (0.52%)  10
COMA  1  1/1913 (0.05%)  1
CONVULSIONS  1  5/1913 (0.26%)  5
DEPRESSED LEVEL OF CONSCIOUSNESS  1  3/1913 (0.16%)  3
DIZZINESS  1  3/1913 (0.16%)  3
ENCEPHALOPATHY  1  1/1913 (0.05%)  1
HEMIPARESIS  1  1/1913 (0.05%)  1
HEPATIC ENCEPHALOPATHY  1  1/1913 (0.05%)  1
HYPOAESTHESIA  1  2/1913 (0.10%)  2
LOSS OF CONSCIOUSNESS  1  1/1913 (0.05%)  1
METABOLIC ENCEPHALOPATHY  1  1/1913 (0.05%)  1
MIGRAINE WITH AURA  1  1/1913 (0.05%)  1
MYELITIS  1  1/1913 (0.05%)  1
NEUROLOGICAL SYMPTOMS  1  1/1913 (0.05%)  1
NEUROPATHIC PAIN  1  1/1913 (0.05%)  1
NEUROPATHY  1  2/1913 (0.10%)  2
PERIPHERAL NEUROPATHY  1  1/1913 (0.05%)  1
PERIPHERAL SENSORY NEUROPATHY  1  1/1913 (0.05%)  1
SIMPLE PARTIAL SEIZURES  1  1/1913 (0.05%)  1
SOMNOLENCE  1  3/1913 (0.16%)  3
SPINAL CORD COMPRESSION  1  12/1913 (0.63%)  12
SPINAL EPIDURAL HAEMORRHAGE  1  1/1913 (0.05%)  1
STATUS EPILEPTICUS  1  1/1913 (0.05%)  1
SUBARACHNOID HAEMORRHAGE  1  1/1913 (0.05%)  1
SYNCOPE  1  20/1913 (1.05%)  22
THROMBOTIC STROKE  1  1/1913 (0.05%)  1
TRANSIENT ISCHAEMIC ATTACK  1  5/1913 (0.26%)  5
VASOVAGAL ATTACK  1  2/1913 (0.10%)  2
Psychiatric disorders   
AGITATION  1  2/1913 (0.10%)  2
ANXIETY  1  2/1913 (0.10%)  2
CONFUAIONAL STATE  1  28/1913 (1.46%)  31
DELERIUM  1  5/1913 (0.26%)  5
DEPRESSION  1  3/1913 (0.16%)  3
DISORIENTATION  1  1/1913 (0.05%)  1
INSOMNIA  1  1/1913 (0.05%)  1
MANIA  1  2/1913 (0.10%)  2
MENTAL STATUS CHANGES  1  15/1913 (0.78%)  15
MOOD ALTERATION  1  1/1913 (0.05%)  1
PANIC ATTACK  1  1/1913 (0.05%)  1
PSYCHOTIC DISORDER  1  2/1913 (0.10%)  2
Renal and urinary disorders   
ANURIA  1  1/1913 (0.05%)  1
AZOTAEMIA  1  2/1913 (0.10%)  3
MICTURITION DISORDER  1  1/1913 (0.05%)  1
NEPHRITIS INTERSTITIAL  1  1/1913 (0.05%)  1
OLIGURIA  1  1/1913 (0.05%)  1
RENAL FAILURE  1  31/1913 (1.62%)  32
RENAL FAILURE ACUTE  1  41/1913 (2.14%)  45
RENAL FAILURE ACUTE ON CHRONIC  1  3/1913 (0.16%)  3
RENAL FAILURE CHRONIC  1  2/1913 (0.10%)  2
RENAL IMPAIRMENT  1  1/1913 (0.05%)  1
RENAL MASS  1  1/1913 (0.05%)  1
RENAL TUBULAR NECROSIS  1  2/1913 (0.10%)  2
URETHRAL HAEMORRHAGE  1  1/1913 (0.05%)  1
URINARY INCONTINENCE  1  2/1913 (0.10%)  2
URINARY RETENTION  1  3/1913 (0.16%)  3
Reproductive system and breast disorders   
PELVIC PAIN  1  1/1913 (0.05%)  1
Respiratory, thoracic and mediastinal disorders   
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/1913 (0.05%)  1
ACUTE RESPIRATORY FAILURE  1  2/1913 (0.10%)  2
ASPIRATION  1  1/1913 (0.05%)  1
ASTHMA  1  3/1913 (0.16%)  3
BRONCHIAL OBSTRUCTION  1  1/1913 (0.05%)  1
BRONCHITIS  1  10/1913 (0.52%)  10
BRONCHITIS CHRONIC  1  1/1913 (0.05%)  1
BRONCHOSPASM  1  1/1913 (0.05%)  1
CHRONIC OBSTRUCTIVE AIRWAY DISEASE EXACERBATED  1  8/1913 (0.42%)  9
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  3/1913 (0.16%)  4
COUGH  1  5/1913 (0.26%)  5
DYSPNEA  1  42/1913 (2.20%)  46
DYSPNOEA EXERTIONAL  1  1/1913 (0.05%)  1
EPISTAXIS  1  3/1913 (0.16%)  3
HAEMOPTYSIS  1  1/1913 (0.05%)  1
HICCUPS  1  1/1913 (0.05%)  1
HYPOXIA  1  7/1913 (0.37%)  7
LARYNGITIS  1  1/1913 (0.05%)  1
LUNG CONSOLIDATION  1  1/1913 (0.05%)  1
LUNG INFILTRATION  1  5/1913 (0.26%)  5
PHARYNGITIS  1  2/1913 (0.10%)  2
PLEURAL EFFUSION  1  20/1913 (1.05%)  21
PLEURISY  1  1/1913 (0.05%)  1
PLEURITIC PAIN  1  3/1913 (0.16%)  3
PNEUMONIA ASPIRATION  1  5/1913 (0.26%)  5
PNEUMONITIS  1  6/1913 (0.31%)  6
PRODUCTIVE COUGH  1  1/1913 (0.05%)  1
PULMONARY ALVEOLAR HAEMORRHAGE  1  1/1913 (0.05%)  1
PULMONARY CONGESTION  1  1/1913 (0.05%)  1
PULMONARY EMBOLISM  1  29/1913 (1.52%)  29
PULMONARY HYPERTENSION  1  2/1913 (0.10%)  2
PULMONARY OEDEMA  1  2/1913 (0.10%)  2
RESPIRATORY ACIDOSIS  1  1/1913 (0.05%)  1
RESPIRATORY ARREST  1  5/1913 (0.26%)  5
RESPIRATORY DEPRESSION  1  1/1913 (0.05%)  1
RESPIRATORY DISTRESS  1  3/1913 (0.16%)  3
RESPIRATORY FAILURE  1  13/1913 (0.68%)  13
RHINORRHOEA  1  1/1913 (0.05%)  1
UPPER RESPIRATORY TRACT CONGESTION  1  1/1913 (0.05%)  1
Skin and subcutaneous tissue disorders   
CONTUSION  1  2/1913 (0.10%)  2
DERMATITIS BULLOUS  1  1/1913 (0.05%)  1
DERMATITIS MEDICAMENTOSA  1  1/1913 (0.05%)  1
ERYTHEMA MULTIFORME  1  1/1913 (0.05%)  1
RASH  1  5/1913 (0.26%)  5
RASH MACULAR  1  1/1913 (0.05%)  1
SKIN BLEEDING  1  1/1913 (0.05%)  1
SKIN ULCER  1  1/1913 (0.05%)  1
Surgical and medical procedures   
HIP ARTHROPLASTY  1  1/1913 (0.05%)  1
Vascular disorders   
CIRCULATORY COLLAPSE  1  1/1913 (0.05%)  1
DEEP VEIN THROMBOSIS  1  52/1913 (2.72%)  52
EMBOLISM  1  1/1913 (0.05%)  1
GANGRENE  1  1/1913 (0.05%)  1
HAEMATOMA  1  2/1913 (0.10%)  2
HOT FLUSHES  1  1/1913 (0.05%)  1
HYPERTENSION  1  1/1913 (0.05%)  1
HYPERTENSIVE CRISIS  1  1/1913 (0.05%)  1
HYPOTENSION  1  21/1913 (1.10%)  22
ILIAC ARTERY STENOSIS  1  1/1913 (0.05%)  1
ORTHOSTATIC HYPOTENSION  1  2/1913 (0.10%)  2
PERIPHERAL ARTERY ANEURYSM  1  1/1913 (0.05%)  1
PERIPHERAL ISCHAEMIA  1  1/1913 (0.05%)  1
SUPERIOR VENA CAVAL OCCLUSION  1  1/1913 (0.05%)  1
THROMBOPHLEBITIS  1  1/1913 (0.05%)  1
THROMBOPHLEBITIS SUPERFICIAL  1  2/1913 (0.10%)  2
THROMBOSIS  1  4/1913 (0.21%)  4
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%
Lenalidomide
Affected / at Risk (%) # Events
Total   1877/1913 (98.12%)    
Blood and lymphatic system disorders   
ANAEMIA  1  423/1913 (22.11%)  606
NEUTROPENIA  1  618/1913 (32.31%)  1185
THROMBOCYTOPENIA  1  408/1913 (21.33%)  725
Eye disorders   
VISION BLURRED  1  154/1913 (8.05%)  164
Gastrointestinal disorders   
CONSTIPATION  1  471/1913 (24.62%)  540
DIARRHOEA  1  430/1913 (22.48%)  572
DYSPEPSIA  1  129/1913 (6.74%)  148
NAUSEA  1  362/1913 (18.92%)  455
STOMATITIS  1  123/1913 (6.43%)  140
VOMITING  1  142/1913 (7.42%)  187
General disorders   
ASTHENIA  1  277/1913 (14.48%)  338
FATIGUE  1  1072/1913 (56.04%)  1448
OEDEMA PERIPHERAL  1  285/1913 (14.90%)  371
PYREXIA  1  233/1913 (12.18%)  297
Infections and infestations   
UPPER RESPIRATORY TRACT INFECTION  1  250/1913 (13.07%)  325
Investigations   
WEIGHT DECREASED  1  115/1913 (6.01%)  126
Metabolism and nutrition disorders   
ANOREXIA  1  195/1913 (10.19%)  221
APPETITE DECREASED  1  111/1913 (5.80%)  118
HYPERGLYCAEMIA  1  127/1913 (6.64%)  189
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  218/1913 (11.40%)  267
BACK PAIN  1  276/1913 (14.43%)  322
MUSCLE CRAMP  1  490/1913 (25.61%)  713
MUSCLE WEAKNESS  1  146/1913 (7.63%)  183
PAIN IN LIMB  1  136/1913 (7.11%)  162
Nervous system disorders   
DIZZINESS  1  261/1913 (13.64%)  321
DYSGEUSIA  1  171/1913 (8.94%)  185
HEADACHE  1  173/1913 (9.04%)  211
HYPOAESTHESIA  1  106/1913 (5.54%)  120
NEUROPATHY  1  149/1913 (7.79%)  189
PERIPHERAL NEUROPATHY  1  104/1913 (5.44%)  123
TREMOR  1  198/1913 (10.35%)  236
Psychiatric disorders   
CONFUSIONAL STATE  1  100/1913 (5.23%)  116
INSOMNIA  1  386/1913 (20.18%)  424
Respiratory, thoracic and mediastinal disorders   
COUGH  1  301/1913 (15.73%)  349
DYSPNOEA  1  296/1913 (15.47%)  355
DYSPNOEA EXERTIONAL  1  98/1913 (5.12%)  110
EPISTAXIS  1  114/1913 (5.96%)  129
NASOPHARYNGITIS  1  161/1913 (8.42%)  209
Skin and subcutaneous tissue disorders   
CONTUSION  1  123/1913 (6.43%)  154
RASH  1  273/1913 (14.27%)  368
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
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 D. Knight, M.D.
Organization: Celgene Corporation
Phone: 908-673-9749
EMail: rknight@celgene.com
Layout table for additonal information
Responsible Party: Robert Knight, MD / Vice President, Clinical Research - Hematology, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179647     History of Changes
Obsolete Identifiers: NCT00331903
Other Study ID Numbers: CC-5013-MM-016
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: December 21, 2009
Results First Posted: March 3, 2010
Last Update Posted: March 16, 2010