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Trial record 22 of 495 for:    LENALIDOMIDE AND every 28 days

Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality

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ClinicalTrials.gov Identifier: NCT00065156
Recruitment Status : Completed
First Posted : July 18, 2003
Results First Posted : June 9, 2010
Last Update Posted : October 10, 2011
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myelodysplastic Syndromes
Intervention Drug: lenalidomide
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Period Title: Overall Study
Started 148
Modified Intent to Treat Population 94
Completed 24 [1]
Not Completed 124
Reason Not Completed
Adverse Event             37
Lack of Efficacy             52
Withdrawal by Subject             8
Lost to Follow-up             1
Death             11
Study Closed by Sponsor             2
Disease Progression             7
Investigator Decision             2
Non-Compliance             2
Loss of Response             1
Secondary Malign Disease             1
[1]
24 patients rolled over to free drug due to sponsor closure of study.
Arm/Group Title Lenalidomide
Hide Arm/Group Description The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Baseline Participants 148
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
70.0  (10.50)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
<= 65 years 48
>65 years 100
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
Female
97
  65.5%
Male
51
  34.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
White 143
Hispanic 3
Asian/Pacific Islander 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
United States 112
Germany 36
Duration of Myelodysplastic Syndrome (MDS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
3.4  (3.29)
[1]
Measure Description: Time from diagnosis of MDS until study start.
Participants with 5q(-) (31-33) Chromosomal Abnormality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
148
International Prognostic Scoring System (IPSS) Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
Low (0) 49
Intermediate-1 (0.5 to 1.0) 69
Intermediate-2 (1.5 to 2.0) 7
High (>=2.5) 2
Missing (unable to assign) 21
[1]
Measure Description: The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis. The assessment was performed by the Central Reviewer.
French-American-British (FAB) Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
Refractory anemia (RA) 78
Refractory anemia with ringed sideroblasts (RARS) 16
Refractory anemia with excess blasts (RAEB) 30
Chronic myelomonocytic leukemia (CMML) 3
Acute leukemia 1
Unable to classify 20
[1]
Measure Description: FAB is a classification system for five (5) subtypes of myelodysplastic syndrome that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts or a monocytosis. Classification was made by the Central Reviewer.
Cytogenetic Complexity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
Isolated 5q 110
Intermediate (5q + 1 abnormality) 25
Complex 12
Unknown 1
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
0 59
1 75
2 14
3 - 5 0
[1]
Measure Description:

ECOG indicates a person's ability to perform life's functions on a scale of 0-5:

0= fully active and no restrictions

  1. restricted but ambulatory and capable of light work
  2. ambulatory and capable of self-care but unable to work

3-4= increasingly restricted

5= dead

1.Primary Outcome
Title Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence
Hide Description Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description

Modified Intent to Treat (MITT)

  • diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation
  • received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period
  • received ≥1 dose of study drug
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: participants
59
2.Secondary Outcome
Title Participants With Adverse Experiences
Hide Description

Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.

The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.

Time Frame Up to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: participants
At least one AE 148
At least one AE related to study drug 143
At least one NCI CTC grade 3-4 AE 140
At least one NCI CTC grade 3-4 AE related to drug 131
At least one serious AE 89
At least one serious AE related to study drug 40
AE leading to dose reduction or interruption 131
AE leading to discontinuation of study drug 47
3.Secondary Outcome
Title Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study
Hide Description A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment).
Time Frame Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Modified Intent to Treat (MITT)

  • diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation
  • received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period
  • received ≥1 dose of study drug
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: participant
70
4.Secondary Outcome
Title Time to Transfusion Independence
Hide Description Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population who achieved transfusion independence
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: weeks
6.2  (6.89)
5.Secondary Outcome
Title Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study
Hide Description Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population who achieved transfusion independence
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
Relapsed (had a transfusion after response) 35
Maintained transfusion independence 24
6.Secondary Outcome
Title Kaplan Meier Estimate for Duration of Transfusion Independence Response
Hide Description Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population who achieved transfusion independence
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 59
Median (95% Confidence Interval)
Unit of Measure: weeks
97.0
(52.9 to 191.9)
7.Secondary Outcome
Title Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders
Hide Description The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline.
Time Frame Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population who achieved transfusion independence
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: g/dL
6.1  (1.92)
8.Secondary Outcome
Title Participant Counts of Cytogenetic Response
Hide Description

Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least

1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline.

Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
Major 18
Minor 20
None 14
9.Secondary Outcome
Title Participant Counts of Platelet Response
Hide Description

Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.

Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions.

Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count <100 * 10^9/L to be included in the analysis.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Major 2
Minor 0
None 13
10.Secondary Outcome
Title Participant Counts of Absolute Neutrophil Count (ANC) Response
Hide Description

Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of

≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days.

Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) <1 * 10^9/L.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participant
Major 9
Minor 0
None 18
11.Secondary Outcome
Title Participants With Complete or Partial Bone Marrow Improvement
Hide Description Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: participants
Complete bone marrow improvement 22
Partial bone marrow improvement 15
12.Secondary Outcome
Title Participants With Bone Marrow Progression
Hide Description

Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):

  • Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).
  • Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML).
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: participants
RA/RARS to RAEB 11
RA/RARS/RAEB/CMML to AML 6
Time Frame Up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   89/148 (60.14%) 
Blood and lymphatic system disorders   
Neutropenia   10/148 (6.76%) 
Anaemia NOS   8/148 (5.41%) 
Febrile Neutropenia   8/148 (5.41%) 
Thrombocytopenia   6/148 (4.05%) 
Leukopenia NOS   3/148 (2.03%) 
Pancytopenia   3/148 (2.03%) 
Coagulopathy   1/148 (0.68%) 
Cardiac disorders   
Cardiac Failure Congestive   6/148 (4.05%) 
Atrial Fibrillation   3/148 (2.03%) 
Cardiac Failure NOS   2/148 (1.35%) 
Myocardial Infarction   2/148 (1.35%) 
Cardio-Respiratory Arrest   1/148 (0.68%) 
Cardiomyopathy NOS   1/148 (0.68%) 
Diastolic Dysfunction   1/148 (0.68%) 
Pulmonary Oedema NOS   1/148 (0.68%) 
Tachyarrhythmia   1/148 (0.68%) 
Ear and labyrinth disorders   
Vertigo   1/148 (0.68%) 
Gastrointestinal disorders   
Vomiting NOS   5/148 (3.38%) 
Abdominal Pain NOS   4/148 (2.70%) 
Diarrhoea NOS   4/148 (2.70%) 
Gastroenteritis NOS   3/148 (2.03%) 
Nausea   3/148 (2.03%) 
Rectal Haemorrhage   2/148 (1.35%) 
Colitis Ischaemic   1/148 (0.68%) 
Colonic Polyp   1/148 (0.68%) 
Constipation   1/148 (0.68%) 
Dysphagia   1/148 (0.68%) 
Gastritis NOS   1/148 (0.68%) 
Gastrooesophageal Reflux Disease   1/148 (0.68%) 
Hiatus Hernia   1/148 (0.68%) 
Intestinal Perforation NOS   1/148 (0.68%) 
Irritable Bowel Syndrome   1/148 (0.68%) 
Oesophageal Perforation   1/148 (0.68%) 
Perirectal Abscess   1/148 (0.68%) 
General disorders   
Pyrexia   4/148 (2.70%) 
Asthenia   2/148 (1.35%) 
Fall   2/148 (1.35%) 
Fatigue   2/148 (1.35%) 
Multi-Organ Failure   2/148 (1.35%) 
Chest Pain   1/148 (0.68%) 
Intermittent Pyrexia   1/148 (0.68%) 
Rigors   1/148 (0.68%) 
Sudden Death   1/148 (0.68%) 
Hepatobiliary disorders   
Cholecystitis NOS   1/148 (0.68%) 
Hyperbilirubinaemia   1/148 (0.68%) 
Immune system disorders   
Hypersensitivity NOS   1/148 (0.68%) 
Infections and infestations   
Pneumonia Not Otherwise Specified (NOS)   15/148 (10.14%) 
Sepsis NOS   6/148 (4.05%) 
Bacteraemia   2/148 (1.35%) 
Cellulitis   2/148 (1.35%) 
Infection NOS   2/148 (1.35%) 
Urinary Tract Infection NOS   2/148 (1.35%) 
Bronchitis Acute NOS   1/148 (0.68%) 
Central Line Infection   1/148 (0.68%) 
Clostridial Infection NOS   1/148 (0.68%) 
Enterobacter Sepsis   1/148 (0.68%) 
Groin Infection   1/148 (0.68%) 
Herpes Zoster   1/148 (0.68%) 
Influenza   1/148 (0.68%) 
Klebsiella Sepsis   1/148 (0.68%) 
Lobar Pneumonia NOS   1/148 (0.68%) 
Post Procedural Site Wound Infection   1/148 (0.68%) 
Sinusitis Acute NOS   1/148 (0.68%) 
Sinusitis NOS   1/148 (0.68%) 
Vaginosis Fungal NOS   1/148 (0.68%) 
Injury, poisoning and procedural complications   
Femoral Neck Fracture   2/148 (1.35%) 
Femur Fracture   2/148 (1.35%) 
Medical Device Complication   2/148 (1.35%) 
Comminuted Fracture   1/148 (0.68%) 
Hip Fracture   1/148 (0.68%) 
Overdose NOS   1/148 (0.68%) 
Spinal Compression Fracture   1/148 (0.68%) 
Investigations   
Blood Creatinine Increased   1/148 (0.68%) 
Troponin I Increased   1/148 (0.68%) 
Metabolism and nutrition disorders   
Dehydration   8/148 (5.41%) 
Hypernatraemia   1/148 (0.68%) 
Hypoglycaemia NOS   1/148 (0.68%) 
Musculoskeletal and connective tissue disorders   
Arthrlagia   1/148 (0.68%) 
Back Pain   1/148 (0.68%) 
Localised Osteoarthritis   1/148 (0.68%) 
Osteolysis   1/148 (0.68%) 
Periarthritis   1/148 (0.68%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute Leukaemia NOS   7/148 (4.73%) 
Acute Myeloid Leukaemia NOS   3/148 (2.03%) 
B-Cell Lymphoma NOS   1/148 (0.68%) 
Carcinoid Tumour of the Small Bowel   1/148 (0.68%) 
Lung Cancer Metastatic   1/148 (0.68%) 
Multiple Myeloma   1/148 (0.68%) 
Ovarian Cancer NOS   1/148 (0.68%) 
Refractory Anaemia with Excess Blasts in Transformation   1/148 (0.68%) 
Thymoma NOS   1/148 (0.68%) 
Nervous system disorders   
Dizziness   3/148 (2.03%) 
Cerebrovascular Accident   2/148 (1.35%) 
Depressed Level of Consciousness   2/148 (1.35%) 
Syncope   2/148 (1.35%) 
Transient Ischaemic Attack   2/148 (1.35%) 
Aphasia   1/148 (0.68%) 
Cerebral Haemorrhage   1/148 (0.68%) 
Convulsions NOS   1/148 (0.68%) 
Dementia NOS   1/148 (0.68%) 
Headache   1/148 (0.68%) 
Hypertensive Encephalopathy   1/148 (0.68%) 
Migraine NOS   1/148 (0.68%) 
Senile Dementia NOS   1/148 (0.68%) 
Subarachnoid Haemorrhage NOS   1/148 (0.68%) 
Subdural Haematoma   1/148 (0.68%) 
Renal and urinary disorders   
Renal Failure NOS   2/148 (1.35%) 
Azotaemia   1/148 (0.68%) 
Renal Failure Acute   1/148 (0.68%) 
Reproductive system and breast disorders   
Cervical Dysplasia   1/148 (0.68%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Embolism   5/148 (3.38%) 
Dyspnoea NOS   2/148 (1.35%) 
Pleural Effusion   2/148 (1.35%) 
Pneumonitis NOS   2/148 (1.35%) 
Pulmonary Hypertension NOS   2/148 (1.35%) 
Asthma NOS   1/148 (0.68%) 
Chronic Obstructive Airways Disease Exacerbated   1/148 (0.68%) 
Epistaxis   1/148 (0.68%) 
Lung Infiltration NOS   1/148 (0.68%) 
Respiratory Distress   1/148 (0.68%) 
Respiratory Failure   1/148 (0.68%) 
Skin and subcutaneous tissue disorders   
Rash NOS   2/148 (1.35%) 
Acute Febrile Neutrophilic Dermatosis   1/148 (0.68%) 
Dermatitis Medicamentosa   1/148 (0.68%) 
Vascular disorders   
Deep Vein Thrombosis   5/148 (3.38%) 
Hypotension NOS   1/148 (0.68%) 
Peripheral Ischaemia   1/148 (0.68%) 
Thrombophlebitis Superficial   1/148 (0.68%) 
Indicates events were collected by systematic assessment
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   148/148 (100.00%) 
Blood and lymphatic system disorders   
Thrombocytopenia   93/148 (62.84%) 
Neutropenia   91/148 (61.49%) 
Anaemia NOS   32/148 (21.62%) 
Leukopenia NOS   19/148 (12.84%) 
Cardiac disorders   
Palpitations   10/148 (6.76%) 
Endocrine disorders   
Acquired Hypothyroidism   14/148 (9.46%) 
Eye disorders   
Conjunctivitis   9/148 (6.08%) 
Vision Blurred   8/148 (5.41%) 
Gastrointestinal disorders   
Diarrhoea Not Otherwise Specified (NOS)   87/148 (58.78%) 
Nausea   41/148 (27.70%) 
Constipation   39/148 (26.35%) 
Abdominal Pain NOS   24/148 (16.22%) 
Vomiting NOS   18/148 (12.16%) 
Abdominal Pain Upper   14/148 (9.46%) 
Dry Mouth   12/148 (8.11%) 
Loose Stools   12/148 (8.11%) 
Toothache   11/148 (7.43%) 
Flatulence   8/148 (5.41%) 
General disorders   
Fatigue   62/148 (41.89%) 
Oedema Peripheral   40/148 (27.03%) 
Pyrexia   37/148 (25.00%) 
Asthenia   22/148 (14.86%) 
Oedema NOS   18/148 (12.16%) 
Pain NOS   14/148 (9.46%) 
Fall   13/148 (8.78%) 
Chest Pain   11/148 (7.43%) 
Rigors   9/148 (6.08%) 
Infections and infestations   
Upper Respiratory Tract Infection NOS   33/148 (22.30%) 
Urinary Tract Infection NOS   21/148 (14.19%) 
Sinusitis NOS   19/148 (12.84%) 
Cellulitis   12/148 (8.11%) 
Influenza   11/148 (7.43%) 
Herpes Simplex   8/148 (5.41%) 
Investigations   
Alanine Aminotransferase Increased   12/148 (8.11%) 
Weight Decreased   12/148 (8.11%) 
Metabolism and nutrition disorders   
Hypokalaemia   22/148 (14.86%) 
Anorexia   20/148 (13.51%) 
Hypomagnesaemia   11/148 (7.43%) 
Appetite Decreased NOS   8/148 (5.41%) 
Hypocalcaemia   8/148 (5.41%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   46/148 (31.08%) 
Back Pain   39/148 (26.35%) 
Muscle Cramp   31/148 (20.95%) 
Pain in Limb   25/148 (16.89%) 
Myalgia   19/148 (12.84%) 
Peripheral Swelling   14/148 (9.46%) 
Pain in Foot   10/148 (6.76%) 
Neck Pain   8/148 (5.41%) 
Nervous system disorders   
Dizziness   35/148 (23.65%) 
Headache   33/148 (22.30%) 
Hypoaesthesia   11/148 (7.43%) 
Dysgeusia   10/148 (6.76%) 
Paraesthesia   10/148 (6.76%) 
Peripheral Neuropathy NOS   10/148 (6.76%) 
Peripheral Sensory Neuropathy   8/148 (5.41%) 
Psychiatric disorders   
Insomnia   19/148 (12.84%) 
Depression   14/148 (9.46%) 
Anxiety   8/148 (5.41%) 
Renal and urinary disorders   
Dysuria   12/148 (8.11%) 
Respiratory, thoracic and mediastinal disorders   
Nasopharyngitis   44/148 (29.73%) 
Cough   38/148 (25.68%) 
Dyspnoea NOS   37/148 (25.00%) 
Pharyngitis   29/148 (19.59%) 
Epistaxis   24/148 (16.22%) 
Bronchitis NOS   17/148 (11.49%) 
Dyspnoea Exertional   16/148 (10.81%) 
Rhinitis NOS   12/148 (8.11%) 
Rhinorrhoea   8/148 (5.41%) 
Skin and subcutaneous tissue disorders   
Pruritus   66/148 (44.59%) 
Rash NOS   54/148 (36.49%) 
Dry Skin   21/148 (14.19%) 
Contusion   18/148 (12.16%) 
Night Sweats   16/148 (10.81%) 
Sweating Increased   13/148 (8.78%) 
Erythema   12/148 (8.11%) 
Alopecia   10/148 (6.76%) 
Ecchymosis   10/148 (6.76%) 
Skin Lesions NOS   8/148 (5.41%) 
Vascular disorders   
Hypertension NOS   13/148 (8.78%) 
Indicates events were collected by systematic assessment
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.
Unless approved by Celgene, single center data will not be published before multicenter data, unless more than 1 year has elapsed since completion of the Study. Thereafter, Investigator may publish single center data provided that Investigator shall: i) provide a copy of the publication to Celgene at least 60 days in advance of submission for publication; ii) delete Celgene Confidential Information and; iii) delay submission up to 90 additional days to permit intellectual property filings.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Publications of Results:
A.F. List, et.al. Results of the MDS-002 and -003 international phase II studies evaluating lenalidomide (CC-5013; Revlimid) in the treatment of transfusion-dependent (TD) patients with myelodysplastic syndrome (MDS). European Hematology Association 10th Conference June 2-5, 2005 Abstract #0772
Layout table for additonal information
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00065156     History of Changes
Obsolete Identifiers: NCT00074126
Other Study ID Numbers: CC-5013-MDS-003
First Submitted: July 17, 2003
First Posted: July 18, 2003
Results First Submitted: August 31, 2009
Results First Posted: June 9, 2010
Last Update Posted: October 10, 2011