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Trial record 12 of 374 for:    LENALIDOMIDE AND Dexamethasone

A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00928486
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : June 14, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide and Dexamethasone
Hide Arm/Group Description Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Period Title: Overall Study
Started 25
Efficacy Evaluable (EE) 24 [1]
Completed 15 [2]
Not Completed 10
Reason Not Completed
Adverse Event             2
Disease Progression             7
Withdrawal by Subject             1
[1]
EE population = given at least 1 dose of study drug, evaluated for efficacy and met eligibility
[2]
Completed = those who continued responding to treatment; upon marketing approval, given lenalidomide
Arm/Group Title Lenalidomide and Dexamethasone
Hide Arm/Group Description Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Safety Population = includes all participants who received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
62.1  (9.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
13
  52.0%
Male
12
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 25 participants
25
1.Primary Outcome
Title Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Hide Description A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)
Time Frame Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all 25 participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Any Adverse Event (AE) 25
Drug-Related AE 25
Grade 3-4 Adverse Event 22
Drug-Related Grade 3-4 AE 21
Serious Adverse Event (SAE) 12
Drug-Related SAE 9
AE Leading to Study Drug Discontinuation 4
Related AE Leading to Len/Dex Discontinuation 2
AE leading to dose reduction or interruption 17
Related AE leading to dose reduction/interruption 16
2.Secondary Outcome
Title Myeloma Response Rate
Hide Description Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.
Time Frame From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria
Arm/Group Title Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of participants
62.5
3.Secondary Outcome
Title Kaplan-Meier Estimates of Duration of Response (DoR)
Hide Description Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia >11.5mg/dL
Time Frame From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders
Arm/Group Title Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
[1]
The median duration of response estimate was not reached at the last time data was censored at the last assessment date with no evidence of progression.
Time Frame Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide and Dexamethasone
Hide Arm/Group Description Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
All-Cause Mortality
Lenalidomide and Dexamethasone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide and Dexamethasone
Affected / at Risk (%)
Total   12/25 (48.00%) 
Cardiac disorders   
Myocardial infarction  1  1/25 (4.00%) 
Ear and labyrinth disorders   
Vertigo positional  1  1/25 (4.00%) 
Eye disorders   
Cataract  1  1/25 (4.00%) 
Gastrointestinal disorders   
Diarrhoea  1  1/25 (4.00%) 
General disorders   
Death  1  1/25 (4.00%) 
Pyrexia  1  1/25 (4.00%) 
Hepatobiliary disorders   
Cholecystitis  1  1/25 (4.00%) 
Hepatic function abnormal  1  1/25 (4.00%) 
Immune system disorders   
Amyloidosis  1  1/25 (4.00%) 
Infections and infestations   
Herpes zoster  1  1/25 (4.00%) 
Injury, poisoning and procedural complications   
Fractured sacrum  1  1/25 (4.00%) 
Pelvic fracture  1  1/25 (4.00%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/25 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Gastric cancer  1  1/25 (4.00%) 
Waldenstrom's macroglobulinaemia  1  1/25 (4.00%) 
Nervous system disorders   
Diplegia 1 ( 4.0)  1  1/25 (4.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/25 (4.00%) 
Vascular disorders   
Orthostatic hypotension  1  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide and Dexamethasone
Affected / at Risk (%)
Total   25/25 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  20/25 (80.00%) 
Lymphopenia  1  16/25 (64.00%) 
Leukopenia  1  15/25 (60.00%) 
Thrombocytopenia  1  13/25 (52.00%) 
Anaemia  1  7/25 (28.00%) 
Cardiac disorders   
Palpitations  1  3/25 (12.00%) 
Arrhythmia  1  2/25 (8.00%) 
Eye disorders   
Conjunctivitis  1  2/25 (8.00%) 
Gastrointestinal disorders   
Constipation  1  13/25 (52.00%) 
Diarrhoea  1  2/25 (8.00%) 
Stomatitis  1  3/25 (12.00%) 
Abdominal discomfort  1  2/25 (8.00%) 
Dental caries  1  2/25 (8.00%) 
Vomiting  1  2/25 (8.00%) 
General disorders   
Malaise  1  7/25 (28.00%) 
Face oedema  1  3/25 (12.00%) 
Pyrexia  1  3/25 (12.00%) 
Fatigue  1  2/25 (8.00%) 
Oedema  1  2/25 (8.00%) 
Oedema peripheral  1  2/25 (8.00%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  6/25 (24.00%) 
Hyperbilirubinaemia  1  3/25 (12.00%) 
Infections and infestations   
Nasopharyngitis  1  12/25 (48.00%) 
Bronchitis  1  4/25 (16.00%) 
Influenza  1  2/25 (8.00%) 
Pharyngitis  1  2/25 (8.00%) 
Pneumonia  1  2/25 (8.00%) 
Sinusitis  1  2/25 (8.00%) 
Investigations   
Fibrin D dimer increased  1  6/25 (24.00%) 
Blood glucose increased  1  5/25 (20.00%) 
Fibrin degradation products increased  1  5/25 (20.00%) 
Alanine aminotransferase increased  1  3/25 (12.00%) 
Aspartate aminotransferase increased  1  3/25 (12.00%) 
Weight decreased  1  3/25 (12.00%) 
C-reactive protein increased  1  2/25 (8.00%) 
Metabolism and nutrition disorders   
Hypophosphataemia  1  4/25 (16.00%) 
Hypokalaemia  1  3/25 (12.00%) 
Hyperglycaemia  1  2/25 (8.00%) 
Hypoalbuminaemia  1  2/25 (8.00%) 
Hyponatraemia  1  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  4/25 (16.00%) 
Nervous system disorders   
Dysgeusia  1  6/25 (24.00%) 
Tremor  1  4/25 (16.00%) 
Dizziness  1  3/25 (12.00%) 
Headache  1  2/25 (8.00%) 
Hypoaesthesia  1  2/25 (8.00%) 
Hypogeusia  1  2/25 (8.00%) 
Psychiatric disorders   
Insomnia  1  6/25 (24.00%) 
Anxiety  1  3/25 (12.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  8/25 (32.00%) 
Dry skin  1  4/25 (16.00%) 
Vascular disorders   
Hot flush  1  2/25 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, 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 Corporation
ClinicalTrials.gov Identifier: NCT00928486     History of Changes
Other Study ID Numbers: CC-5013-MM-022
First Submitted: June 9, 2009
First Posted: June 26, 2009
Results First Submitted: May 6, 2016
Results First Posted: June 14, 2016
Last Update Posted: June 14, 2016