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Trial record 23 of 494 for:    LENALIDOMIDE AND every 28 days

A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

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: NCT00413036
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : April 11, 2013
Last Update Posted : March 1, 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 Lymphoma, Non-Hodgkin's
Intervention Drug: lenalidomide
Enrollment 217
Recruitment Details  
Pre-assignment Details 217 participants were enrolled and received at least one dose of study medication.
Arm/Group Title Lenalidomide
Hide Arm/Group Description 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Period Title: Overall Study
Started 217
Completed 0 [1]
Not Completed 217
Reason Not Completed
Adverse Event             44
Lack of Efficacy             129
Withdrawal by Subject             7
Death             9
Other             26
Missing             2
[1]
Participants remain on study drug until progressive disease or unacceptable adverse events develop.
Arm/Group Title Lenalidomide
Hide Arm/Group Description 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Number of Baseline Participants 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants
65.0  (11.54)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants
< 65 years 90
> = 65 years 127
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants
Female
77
  35.5%
Male
140
  64.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 217 participants
American Indian or Alaska Native 0
Asian/Pacific Islander 0
Black 4
Hispanic 2
White 202
Unspecified 9
Non-Hodgkin's Lymphoma Diagnosis/Histopathology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants
Diffuse Large Cell Lymphoma 108
Follicular Lymphoma, Grade 3 19
Mantle Cell Lymphoma 57
Transformed Lymphoma 33
1.Primary Outcome
Title Participants Categorized by Best Response as Determined by Central Review
Hide Description

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

  • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
  • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
  • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
  • Stable Disease(SD): Less than PR, but not progressive disease.
  • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
Time Frame Up to 1459 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 217
Measure Type: Number
Unit of Measure: Participants
Complete Response (CR) 7
Complete Response Unconfirmed (CRu) 21
Partial Response (PR) 40
Stable Disease (SD) 71
Progressive Disease 78
2.Secondary Outcome
Title Duration of Response as Determined by Central Review
Hide Description

Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.

For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.

Time Frame Up to 1459 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 217
Median (95% Confidence Interval)
Unit of Measure: Months
18.4
(6.51 to 34.06)
3.Secondary Outcome
Title Time to Progression as Determined by Central Review
Hide Description

Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

  • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
Time Frame Up to 1459 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 217
Median (95% Confidence Interval)
Unit of Measure: Months
4.5
(3.68 to 6.28)
4.Secondary Outcome
Title Progression-free Survival as Determined by Central Review
Hide Description

Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

  • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
Time Frame Up to 1459 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 217
Median (95% Confidence Interval)
Unit of Measure: Months
4.5
(3.68 to 6.28)
5.Secondary Outcome
Title Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review
Hide Description

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

  • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
  • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
  • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
  • Stable Disease(SD): Less than PR, but not progressive disease.
Time Frame Up to 1459 days
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 1459 days
Adverse Event Reporting Description Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   102/217 (47.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  11/217 (5.07%) 
Anaemia  1  6/217 (2.76%) 
Febrile Neutropenia  1  6/217 (2.76%) 
Thrombocytopenia  1  5/217 (2.30%) 
Pancytopenia  1  4/217 (1.84%) 
Leukopenia  1  2/217 (0.92%) 
Lymphadenopathy  1  1/217 (0.46%) 
Splenic Infarction  1  1/217 (0.46%) 
Cardiac disorders   
Cardio-Respiratory Arrest  1  3/217 (1.38%) 
Cardiac Arrest  1  2/217 (0.92%) 
Myocardial Infarction  1  2/217 (0.92%) 
Atrial Fibrillation  1  1/217 (0.46%) 
Cardiac Failure Congestive  1  1/217 (0.46%) 
Sinus Tachycardia  1  1/217 (0.46%) 
Tachycardia  1  1/217 (0.46%) 
Congenital, familial and genetic disorders   
Pyloric Stenosis  1  1/217 (0.46%) 
Eye disorders   
Diplopia  1  1/217 (0.46%) 
Gastrointestinal disorders   
Abdominal Pain  1  4/217 (1.84%) 
Diarrhoea  1  3/217 (1.38%) 
Vomiting  1  3/217 (1.38%) 
Abdominal Pain Upper  1  2/217 (0.92%) 
Nausea  1  2/217 (0.92%) 
Small Intestinal Obstruction  1  2/217 (0.92%) 
Colitis  1  1/217 (0.46%) 
Constipation  1  1/217 (0.46%) 
Dysphagia  1  1/217 (0.46%) 
Gastritis  1  1/217 (0.46%) 
Gastrointestinal Haemorrhage  1  1/217 (0.46%) 
Intestinal Obstruction  1  1/217 (0.46%) 
Pancreatitis  1  1/217 (0.46%) 
Rectal Haemorrhage  1  1/217 (0.46%) 
General disorders   
Pyrexia  1  12/217 (5.53%) 
General Physical Health Deterioration  1  8/217 (3.69%) 
Asthenia  1  7/217 (3.23%) 
Multi-Organ Failure  1  4/217 (1.84%) 
Fatigue  1  3/217 (1.38%) 
Non-Cardiac Chest Pain  1  3/217 (1.38%) 
Disease Progression  1  2/217 (0.92%) 
Oedema Peripheral  1  2/217 (0.92%) 
Pain  1  1/217 (0.46%) 
Performance Status Decreased  1  1/217 (0.46%) 
Sudden Death  1  1/217 (0.46%) 
Hepatobiliary disorders   
Cholangitis  1  1/217 (0.46%) 
Cholelithiasis  1  1/217 (0.46%) 
Cytolytic Hepatitis  1  1/217 (0.46%) 
Jaundice  1  1/217 (0.46%) 
Immune system disorders   
Anaphylactic Shock  1  1/217 (0.46%) 
Infections and infestations   
Urinary Tract Infection  1  1/217 (0.46%) 
West Nile Viral Infection  1  1/217 (0.46%) 
Wound Infection  1  1/217 (0.46%) 
Pneumonia  1  9/217 (4.15%) 
Sepsis  1  5/217 (2.30%) 
Cellulitis  1  2/217 (0.92%) 
Infection  1  2/217 (0.92%) 
Respiratory Tract Infection  1  2/217 (0.92%) 
Appendicitis  1  1/217 (0.46%) 
Bacteraemia  1  1/217 (0.46%) 
Bronchitis Chronic  1  1/217 (0.46%) 
Candidiasis  1  1/217 (0.46%) 
Central Line Infection  1  1/217 (0.46%) 
Clostridial Infection  1  1/217 (0.46%) 
Device Related Infection  1  1/217 (0.46%) 
Gastroeneteritis  1  1/217 (0.46%) 
Lobar Pneumonia  1  1/217 (0.46%) 
Lung Infection  1  1/217 (0.46%) 
Meningitis  1  1/217 (0.46%) 
Neutropenic Sepsis  1  1/217 (0.46%) 
Pharyngitis  1  1/217 (0.46%) 
Staphylococcal Infection  1  1/217 (0.46%) 
Injury, poisoning and procedural complications   
Anastomotic Stenosis  1  1/217 (0.46%) 
Contusion  1  1/217 (0.46%) 
Fall  1  1/217 (0.46%) 
Femur Fracture  1  1/217 (0.46%) 
Fracture  1  1/217 (0.46%) 
Haemothorax  1  1/217 (0.46%) 
Intentional Overdose  1  1/217 (0.46%) 
Joint Dislocation  1  1/217 (0.46%) 
Limb Injury  1  1/217 (0.46%) 
Postoperative Ileus  1  1/217 (0.46%) 
Spinal Compression Fracture  1  1/217 (0.46%) 
Spinal Fracture  1  1/217 (0.46%) 
Investigations   
C-Reactive Protein Increased  1  1/217 (0.46%) 
Liver Function Test Abnormal  1  1/217 (0.46%) 
White Blood Cell Count Decreased  1  1/217 (0.46%) 
Metabolism and nutrition disorders   
Dehydration  1  6/217 (2.76%) 
Hypercalcaemia  1  1/217 (0.46%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  5/217 (2.30%) 
Muscular Weakness  1  1/217 (0.46%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Non-Hodgkin's Lymphoma  1  6/217 (2.76%) 
Acute Myeloid Leukaemia  1  1/217 (0.46%) 
Basal Cell Carcinoma  1  1/217 (0.46%) 
Benign Neoplasm of Thyroid Gland  1  1/217 (0.46%) 
Central Nervous System Lymphoma  1  1/217 (0.46%) 
Gastric Cancer  1  1/217 (0.46%) 
Metastases to Meninges  1  1/217 (0.46%) 
Squamous Cell Carcinoma of Skin  1  1/217 (0.46%) 
Tumour Flare  1  1/217 (0.46%) 
Tumour Lysis Syndrome  1  1/217 (0.46%) 
Tumour Necrosis  1  1/217 (0.46%) 
Nervous system disorders   
Cerebrovascular Accident  1  2/217 (0.92%) 
Syncope  1  2/217 (0.92%) 
Convulsion  1  1/217 (0.46%) 
Dementia  1  1/217 (0.46%) 
Epilepsy  1  1/217 (0.46%) 
Hypoaesthesia  1  1/217 (0.46%) 
Neuropathy Peripheral  1  1/217 (0.46%) 
Paraesthesia  1  1/217 (0.46%) 
Paresis  1  1/217 (0.46%) 
Speech Disorder  1  1/217 (0.46%) 
Tremor  1  1/217 (0.46%) 
Psychiatric disorders   
Confusional State  1  3/217 (1.38%) 
Suicide Attempt  1  1/217 (0.46%) 
Renal and urinary disorders   
Renal Failure Acute  1  4/217 (1.84%) 
Renal Failure  1  3/217 (1.38%) 
Hydronephrosis  1  1/217 (0.46%) 
Urinary Retention  1  1/217 (0.46%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1  8/217 (3.69%) 
Dyspnoea  1  6/217 (2.76%) 
Pulmonary Embolism  1  5/217 (2.30%) 
Hypoxia  1  2/217 (0.92%) 
Lung Disorder  1  2/217 (0.92%) 
Respiratory Failure  1  2/217 (0.92%) 
Asthma  1  1/217 (0.46%) 
Pharyngolaryngeal Pain  1  1/217 (0.46%) 
Pneumonia Aspiration  1  1/217 (0.46%) 
Pneumonitis  1  1/217 (0.46%) 
Pneumonthorax  1  1/217 (0.46%) 
Respiratory Distress  1  1/217 (0.46%) 
Anuria  1  1/217 (0.46%) 
Skin and subcutaneous tissue disorders   
Rash  1  2/217 (0.92%) 
Dermatitis Exfoliative  1  1/217 (0.46%) 
Hypoaesthesia Facial  1  1/217 (0.46%) 
Vascular disorders   
Hypotension  1  5/217 (2.30%) 
Deep Vein Thrombosis  1  4/217 (1.84%) 
Thrombosis  1  1/217 (0.46%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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 (%)
Total   188/217 (86.64%) 
Blood and lymphatic system disorders   
Neutropenia  1  22/217 (10.14%) 
Anaemia  1  18/217 (8.29%) 
Thrombocytopenia  1  17/217 (7.83%) 
Gastrointestinal disorders   
Constipation  1  22/217 (10.14%) 
Nausea  1  18/217 (8.29%) 
Diarrhoea  1  14/217 (6.45%) 
Abdominal pain  1  12/217 (5.53%) 
General disorders   
Fatigue  1  25/217 (11.52%) 
Oedema Peripheral  1  13/217 (5.99%) 
Pyrexia  1  13/217 (5.99%) 
Asthenia  1  12/217 (5.53%) 
Investigations   
White Blood Cell Count Decreased  1  15/217 (6.91%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  15/217 (6.91%) 
Back pain  1  13/217 (5.99%) 
Nervous system disorders   
Dizziness  1  13/217 (5.99%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  16/217 (7.37%) 
Dsypnoea  1  11/217 (5.07%) 
Pharyngolaryngeal Pain  1  11/217 (5.07%) 
Skin and subcutaneous tissue disorders   
Rash  1  20/217 (9.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
Investigator can publish/present study data after multicenter publication is submitted or 1 yr after study completion. Investigator shall (i) furnish the sponsor a copy of any proposed publication/presentation at least 60 days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for up to 90 days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trial Disclosure
Organization: Celgene
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00413036     History of Changes
Other Study ID Numbers: CC-5013-NHL-003
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: January 9, 2013
Results First Posted: April 11, 2013
Last Update Posted: March 1, 2017