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Trial record 43 of 495 for:    LENALIDOMIDE AND every 28 days

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for 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: NCT00622336
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : December 30, 2014
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: Lenalidomide
Enrollment 330
Recruitment Details This was an international, open-label single arm study of oral lenalidomide in participants with multiple myeloma who had previously received high dose dexamethasone alone or in combination with thalidomide in the study NCT 00057564, or previously received high dose dexamethasone alone in studies NCT 00056160 and NCT 00424047.
Pre-assignment Details To be eligible participants must have developed disease progression or were unable to tolerate the lowest dosing regimen of thalidomide and/or high-dose dexamethasone without Grade 3 or 4 toxicity
Arm/Group Title Lenalidomide 25mg
Hide Arm/Group Description Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Period Title: Treatment Phase
Started 330
Safety Population 330
Completed 21 [1]
Not Completed 309
Reason Not Completed
Progression of Disease             181
Adverse Event             46
Other             40
Death             14
Lack of therapeutic effect             13
Withdrawal by Subject             13
Lost to Follow-up             2
[1]
Completed = those who completed the treatment phase and were ongoing in the extension study
Period Title: Extension Phase
Started 21
Completed 0
Not Completed 21
Reason Not Completed
Adverse Event             2
Progressive Disease             6
Lack of therapeutic effect             2
Withdrawal by Subject             1
Lost to Follow-up             1
Other             9
Arm/Group Title Lenalidomide 25mg (CC-5013)
Hide Arm/Group Description Oral 25mg daily on Days 1-21 every 28 days
Overall Number of Baseline Participants 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 330 participants
63.3  (9.43)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 330 participants
> 65 years 136
≤ 65 years 194
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants
Female
137
  41.5%
Male
193
  58.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 330 participants
Asian/Pacific Islander 2
Black or African American 14
White 309
Hispanic 5
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 330 participants
0 = Fully Active 95
1 = Restricted Activity 178
2 = Ambulatory; not able to work 44
3 = Limited Self Care 1
4 = Completely Disabled 0
Missing= Unspecified 12
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
1.Primary Outcome
Title Number of Participants With Adverse Events (AE) During the Treatment Phase
Hide Description An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Time Frame Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.
Arm/Group Title Lenalidomide 25mg (CC-5013)
Hide Arm/Group Description:
Oral 25mg daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 330
Measure Type: Number
Unit of Measure: participants
Adverse Event (AE) 327
Adverse Event related to study drug 268
Adverse Event NCI CTC (Version2.0) Grade 3 or 4 256
Serious Adverse Event (SAE) 177
AE leading to discontinuation of study drug 52
AE leading to dose reduction/interruption 210
2.Primary Outcome
Title Number of Participants With Adverse Events (AE) During the Extension Phase
Hide Description An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Time Frame From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.
Arm/Group Title Lenalidomide 25mg (CC-5013)
Hide Arm/Group Description:
Oral 25mg daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
≥ 1 Adverse Event (AE) 13
Adverse Event related to study drug 1
Adverse Event NCI CTC (Version2.0) Grade 3 or 4 5
≥ 1 Serious Adverse Event (SAE) 5
≥ 1 AE leading to discontinuation of study drug 1
≥ 1 AE leading to dose reduction/interruption 3
3.Secondary Outcome
Title Time to Progression
Hide Description Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression. The progressive disease criteria included increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time Frame Up to 70 months
Hide Outcome Measure Data
Hide Analysis Population Description
Time to progression not analyzed per the sponsors decision.
Arm/Group Title Lenalidomide 25mg
Hide Arm/Group Description:
Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Myeloma Response Rate
Hide Description Myeloma response determination criteria developed by Bladé et al 1998. 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 70 months
Hide Outcome Measure Data
Hide Analysis Population Description
Myeloma Response Rate not analyzed per the sponsors decision.
Arm/Group Title Lenalidomide 25mg
Hide Arm/Group Description:
Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.
Time Frame Up to 70 months
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response not analyzed per the sponsors decision.
Arm/Group Title Lenalidomide 25mg
Hide Arm/Group Description:
Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013
Hide Arm/Group Description Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
All-Cause Mortality
Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013
Affected / at Risk (%) Affected / at Risk (%)
Total   177/330 (53.64%)   5/21 (23.81%) 
Blood and lymphatic system disorders     
Anaemia NOS  1  11/330 (3.33%)  1/21 (4.76%) 
Febrile neutropenia  1  9/330 (2.73%)  0/21 (0.00%) 
Thrombocytopenia  1  9/330 (2.73%)  0/21 (0.00%) 
Leukopenia NOS  1  5/330 (1.52%)  0/21 (0.00%) 
Neutropenia  1  4/330 (1.21%)  0/21 (0.00%) 
Pancytopenia  1  4/330 (1.21%)  0/21 (0.00%) 
Hyperviscosity syndrome  1  2/330 (0.61%)  0/21 (0.00%) 
Disseminated intravascular coagulation  1  1/330 (0.30%)  0/21 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  4/330 (1.21%)  0/21 (0.00%) 
Cardiac failure NOS  1  3/330 (0.91%)  0/21 (0.00%) 
Acute myocardial infarction  1  2/330 (0.61%)  0/21 (0.00%) 
Cardiac failure congestive  1  2/330 (0.61%)  1/21 (4.76%) 
Myocardial infarction  1  2/330 (0.61%)  0/21 (0.00%) 
Angina unstable  1  1/330 (0.30%)  0/21 (0.00%) 
Atrial flutter  1  1/330 (0.30%)  0/21 (0.00%) 
Atrial tachycardia  1  1/330 (0.30%)  0/21 (0.00%) 
Cardio-respiratory arrest  1  1/330 (0.30%)  0/21 (0.00%) 
Coronary artery disease NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Myocardial ischaemia  1  1/330 (0.30%)  0/21 (0.00%) 
Sick sinus syndrome  1  1/330 (0.30%)  0/21 (0.00%) 
Gastrointestinal disorders     
Gastroenteritis NOS  1  4/330 (1.21%)  0/21 (0.00%) 
Constipation  1  3/330 (0.91%)  0/21 (0.00%) 
Diarrhoea NOS  1  3/330 (0.91%)  1/21 (4.76%) 
Abdominal pain NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Oesophagitis NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Periproctitis  1  2/330 (0.61%)  0/21 (0.00%) 
Appendicitis  1  1/330 (0.30%)  0/21 (0.00%) 
Diverticulitis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Enterocolitis  1  1/330 (0.30%)  0/21 (0.00%) 
Gastritis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Gastrointestinal haemorrhage NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Gastrointestinal pain NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Hiatus hernia  1  1/330 (0.30%)  0/21 (0.00%) 
Inguinal hernia NOS  1  1/330 (0.30%)  1/21 (4.76%) 
Intestinal obstruction NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Umbilical hernia NOS  1  1/330 (0.30%)  0/21 (0.00%) 
General disorders     
Pyrexia  1  14/330 (4.24%)  0/21 (0.00%) 
Asthenia  1  7/330 (2.12%)  0/21 (0.00%) 
Multi-organ failure  1  2/330 (0.61%)  0/21 (0.00%) 
Disease progression NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Fatigue  1  1/330 (0.30%)  0/21 (0.00%) 
General physical health deterioration  1  1/330 (0.30%)  1/21 (4.76%) 
Injection site cellulitis  1  1/330 (0.30%)  0/21 (0.00%) 
Lethargy  1  1/330 (0.30%)  0/21 (0.00%) 
Sudden death  1  1/330 (0.30%)  0/21 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Cholelithiasis  1  2/330 (0.61%)  0/21 (0.00%) 
Hepatic failure  1  1/330 (0.30%)  0/21 (0.00%) 
Hepatitis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Hepatitis toxic  1  1/330 (0.30%)  0/21 (0.00%) 
Infections and infestations     
Pneumonia NOS  1  38/330 (11.52%)  2/21 (9.52%) 
Respiratory tract infection NOS  1  6/330 (1.82%)  0/21 (0.00%) 
Lobar pneumonia NOS  1  4/330 (1.21%)  0/21 (0.00%) 
Sepsis NOS  1  4/330 (1.21%)  0/21 (0.00%) 
Bacteraemia  1  3/330 (0.91%)  0/21 (0.00%) 
Bronchitis acute NOS  1  3/330 (0.91%)  0/21 (0.00%) 
Bronchopneumonia NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Cellulitis  1  2/330 (0.61%)  0/21 (0.00%) 
Lung infection NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Pyelonephritis NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Abscess NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Arthritis infective NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Bronchitis chronic NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Candida pneumonia  1  1/330 (0.30%)  0/21 (0.00%) 
Catheter related infection  1  1/330 (0.30%)  0/21 (0.00%) 
Haemophilus sepsis  1  1/330 (0.30%)  0/21 (0.00%) 
Lower respiratory tract infection NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Obstructive chronic bronchitis with acute exacerbation  1  1/330 (0.30%)  0/21 (0.00%) 
Osteomyelitis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Osteomyelitis chronic NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Pneumonia legionella  1  1/330 (0.30%)  0/21 (0.00%) 
Pyelonephritis chronic NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Septic shock  1  1/330 (0.30%)  0/21 (0.00%) 
Streptococcal bacteraemia  1  1/330 (0.30%)  0/21 (0.00%) 
Streptococcal sepsis  1  1/330 (0.30%)  0/21 (0.00%) 
Tracheobronchitis  1  1/330 (0.30%)  0/21 (0.00%) 
Urinary tract infection NOS  1  1/330 (0.30%)  1/21 (4.76%) 
Urosepsis  1  1/330 (0.30%)  0/21 (0.00%) 
Varicella  1  1/330 (0.30%)  0/21 (0.00%) 
Viral infection NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  2/330 (0.61%)  0/21 (0.00%) 
Hip fracture  1  2/330 (0.61%)  0/21 (0.00%) 
Spinal compression fracture  1  2/330 (0.61%)  0/21 (0.00%) 
Accident NOS 1 ( 0.3)  1  1/330 (0.30%)  0/21 (0.00%) 
Femoral neck fracture  1  1/330 (0.30%)  0/21 (0.00%) 
Intracranial injury NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Perirenal haematoma  1  1/330 (0.30%)  0/21 (0.00%) 
Radius fracture  1  1/330 (0.30%)  0/21 (0.00%) 
Spinal fracture NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Investigations     
Liver function tests NOS abnormal  1  2/330 (0.61%)  0/21 (0.00%) 
International normalised ratio increased  1  1/330 (0.30%)  0/21 (0.00%) 
Prostatic specific antigen increased  1  1/330 (0.30%)  0/21 (0.00%) 
Weight decreased  1  1/330 (0.30%)  0/21 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia  1  4/330 (1.21%)  0/21 (0.00%) 
Dehydration  1  2/330 (0.61%)  0/21 (0.00%) 
Diabetes mellitus NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Hyperproteinaemia  1  2/330 (0.61%)  0/21 (0.00%) 
Hypokalaemia  1  1/330 (0.30%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  8/330 (2.42%)  0/21 (0.00%) 
Back pain  1  6/330 (1.82%)  0/21 (0.00%) 
Pathological fracture  1  6/330 (1.82%)  0/21 (0.00%) 
Arthralgia  1  1/330 (0.30%)  0/21 (0.00%) 
Chondrocalcinosis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Jaw osteitis  1  1/330 (0.30%)  0/21 (0.00%) 
Joint swelling  1  1/330 (0.30%)  0/21 (0.00%) 
Localised osteoarthritis  1  1/330 (0.30%)  0/21 (0.00%) 
Neck pain  1  1/330 (0.30%)  0/21 (0.00%) 
Osteoarthritis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Osteonecrosis  1  1/330 (0.30%)  0/21 (0.00%) 
Pain in limb  1  1/330 (0.30%)  0/21 (0.00%) 
Rotator cuff syndrome  1  1/330 (0.30%)  0/21 (0.00%) 
Synovitis  1  1/330 (0.30%)  0/21 (0.00%) 
Tendonitis  1  1/330 (0.30%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Multiple myeloma  1  2/330 (0.61%)  0/21 (0.00%) 
Plasmacytoma  1  2/330 (0.61%)  0/21 (0.00%) 
Prostate cancer NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Basal cell carcinoma  1  1/330 (0.30%)  0/21 (0.00%) 
Brain neoplasm NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Breast cancer NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Cancer pain  1  1/330 (0.30%)  0/21 (0.00%) 
Carcinoid tumour NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Colon cancer NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Craniopharyngioma  1  1/330 (0.30%)  0/21 (0.00%) 
Light chain disease  1  1/330 (0.30%)  0/21 (0.00%) 
Lung cancer stage unspecified  1  1/330 (0.30%)  0/21 (0.00%) 
Mesothelioma  1  1/330 (0.30%)  0/21 (0.00%) 
Myelodysplastic syndrome NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Oesophageal adenocarcinoma NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Anaemia of Malignant Disease  1  0/330 (0.00%)  1/21 (4.76%) 
Nervous system disorders     
Cerebrovascular accident  1  6/330 (1.82%)  0/21 (0.00%) 
Subdural haematoma  1  2/330 (0.61%)  0/21 (0.00%) 
Brain oedema  1  1/330 (0.30%)  0/21 (0.00%) 
Carotid artery stenosis  1  1/330 (0.30%)  0/21 (0.00%) 
Cerebral haemorrhage  1  1/330 (0.30%)  0/21 (0.00%) 
Cerebral infarction  1  1/330 (0.30%)  0/21 (0.00%) 
Cerebral ischaemia  1  1/330 (0.30%)  0/21 (0.00%) 
Cerebrovascular disorder NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Dementia NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Encephalopathy  1  1/330 (0.30%)  0/21 (0.00%) 
Metabolic encephalopathy NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Phantom pain  1  1/330 (0.30%)  0/21 (0.00%) 
Radiculitis brachial  1  1/330 (0.30%)  0/21 (0.00%) 
Spinal cord compression NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Transient ischaemic attack  1  1/330 (0.30%)  0/21 (0.00%) 
Psychiatric disorders     
Confusional state  1  3/330 (0.91%)  0/21 (0.00%) 
Agitation  1  1/330 (0.30%)  0/21 (0.00%) 
Conversion disorder  1  1/330 (0.30%)  0/21 (0.00%) 
Depression  1  1/330 (0.30%)  0/21 (0.00%) 
Disorientation  1  1/330 (0.30%)  0/21 (0.00%) 
Insomnia  1  1/330 (0.30%)  0/21 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  6/330 (1.82%)  0/21 (0.00%) 
Renal failure NOS  1  4/330 (1.21%)  0/21 (0.00%) 
Calculus urinary  1  2/330 (0.61%)  0/21 (0.00%) 
Nephropathy NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Renal failure acute or chronic  1  2/330 (0.61%)  1/21 (4.76%) 
Azotaemia  1  1/330 (0.30%)  0/21 (0.00%) 
Nephropathy toxic  1  1/330 (0.30%)  0/21 (0.00%) 
Renal failure chronic  1  1/330 (0.30%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  5/330 (1.52%)  0/21 (0.00%) 
Bronchitis NOS  1  3/330 (0.91%)  1/21 (4.76%) 
Dyspnoea NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Respiratory failure  1  2/330 (0.61%)  0/21 (0.00%) 
Acute respiratory distress syndrome  1  1/330 (0.30%)  0/21 (0.00%) 
Asthma NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Chronic obstructive airways disease  1  1/330 (0.30%)  0/21 (0.00%) 
Epistaxis  1  1/330 (0.30%)  0/21 (0.00%) 
Hypoxia  1  1/330 (0.30%)  0/21 (0.00%) 
Lung infiltration NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Pneumonitis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Pulmonary thrombosis NOS  1  1/330 (0.30%)  0/21 (0.00%) 
Status asthmaticus  1  1/330 (0.30%)  0/21 (0.00%) 
Pulmonary oedema NOS  1  3/330 (0.91%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Dermatitis medicamentosa  1  1/330 (0.30%)  0/21 (0.00%) 
Toxic skin eruption  1  1/330 (0.30%)  0/21 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  6/330 (1.82%)  0/21 (0.00%) 
Hypotension NOS  1  2/330 (0.61%)  0/21 (0.00%) 
Aortic thrombosis  1  1/330 (0.30%)  0/21 (0.00%) 
Circulatory collapse  1  1/330 (0.30%)  0/21 (0.00%) 
Thrombophlebitis superficial  1  1/330 (0.30%)  0/21 (0.00%) 
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 (Treatment Phase) Up to Data Cut-off 22 Oct 2009 Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013
Affected / at Risk (%) Affected / at Risk (%)
Total   0/330 (0.00%)   6/21 (28.57%) 
Blood and lymphatic system disorders     
Anaemia NOS  1  0/330 (0.00%)  2/21 (9.52%) 
General disorders     
Asthenia  1  0/330 (0.00%)  3/21 (14.29%) 
Nervous system disorders     
Headache  1  0/330 (0.00%)  3/21 (14.29%) 
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.
Investigator has the right to publish and/or present study data after multicentric publication or one year has elapsed until completion this multicentric study provided that he/she (i) furnishes the sponsor a copy of any proposed publication or presentation before its submission, (ii) deletes any sponsor’s confidential data as pointed out by sponsor, and (iii) delays any submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: ClinicalTrialDisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00622336     History of Changes
Other Study ID Numbers: CC-5013-MM-012
2004-002102-30 ( EudraCT Number )
First Submitted: February 14, 2008
First Posted: February 25, 2008
Results First Submitted: December 18, 2014
Results First Posted: December 30, 2014
Last Update Posted: August 15, 2017