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Trial record 60 of 848 for:    LENALIDOMIDE AND Angiogenesis

Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.

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: NCT00812968
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : December 17, 2013
Last Update Posted : December 12, 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 Myelodysplastic Syndromes
Intervention Drug: Lenalidomide
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description 10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).
Period Title: Overall Study
Started 11
Completed 0
Not Completed 11
Reason Not Completed
Relapse after erythroid response             6
Disease progression             1
No further treatment required             1
Study closed due to marketing approval             3
Arm/Group Title Lenalidomide
Hide Arm/Group Description 10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
71.8  (5.95)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 11 participants
11
Duration of MDS  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
2.0  (1.44)
International Prognostic Scoring System (IPSS) Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Low risk 2
Intermediate-1 risk 9
Intermediate-2 risk 0
High risk 0
[1]
Measure Description: The MDS IPSS assesses the severity of MDS based on 3 prognostic factors each assigned a score: the proportion of bone marrow blasts, chromosome changes in the marrow cells (karyotype) and the presence of one or more low blood cell counts (cytopenias). The IPSS score is the sum of the bone marrow blast + karyotype + cytopenia score and ranges from 0 (low risk) to 3.5 (high risk). Prognosis is categorized as Low risk (score = 0), Intermediate-1 (score 0.5 to 1.0), Intermediate-2 (score 1.5 to 2.0) or High risk (score ≥ 2.5).
French-American-British (FAB) classification of MDS   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Refractory anemia (RA) 9
Refractory anemia with ringed sideroblasts (RARS) 0
Refractory anemia with excess blasts (RAEB) 2
Chronic myelomonocytic leukemia (CMML) 0
RAEB in transformation (RAEB-t) 0
[1]
Measure Description: The French-American-British (FAB) classification of MDS recognizes five subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), or a monocytosis.
World Health Organization Classification of MDS   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Refractory anemia (RA) 0
RA with ringed sideroblasts (RARS) 0
Refractory anemia with excess blasts-1 (RAEB-1) 2
Refractory anemia with excess blasts-2 (RAEB-2) 0
Refractory cytopenia multilineage dysplasia (RCMD) 1
RCMD and ringed sideroblasts (RCMD-RS) 0
MDS, unclassified (MDS-U) 0
MDS associated with isolated del(5q) 8
[1]
Measure Description: The World Health Organization (WHO) classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.
Bone Marrow Cellularity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Aplastic (0%) 0
Hypocellular (> 0% to ≤ 30%) 3
Normocellular (> 30% to ≤ 60%) 5
Hypercellular (> 60% to ≤ 90%) 2
Packed (> 90% to ≤ 100%) 0
Missing 1
[1]
Measure Description: Bone marrow cellularity is a measure of the percentage of hematopoietic stem cells relative to fat cells in the bone marrow.
Transfusion Dependency  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Yes 5
No 6
1.Primary Outcome
Title Number of Participants With Adverse Events (AE)
Hide Description

An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):

  • Death;
  • Life-threatening event;
  • Any inpatient hospitalization or prolongation of existing hospitalization;
  • Persistent or significant disability or incapacity;
  • Congenital anomaly or birth defect;
  • Any other important medical event.

The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.

The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.

Time Frame After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all patients who received at least 1 dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 11
AE related to study drug 11
Grade 3 or 4 AE 11
Grade 3 or 4 AE related to study drug 11
Serious AE (SAE) 3
SAE related to study drug 1
AE leading to discontinuation of study drug 0
Related AE leading to discontinuation 0
AE leading to a dose reduction or interruption 10
Related AE leading to dose reduction/interruption 9
Deaths 0
2.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Lenalidomide
Hide Description Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: all patients who adhered to the study treatment during the course of PK assessment (Days 1 to 5 of Cycle 1) and from whom blood and urine samples were collected.
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
136
(43.1%)
149
(31.2%)
3.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Lenalidomide
Hide Description Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 6 5
Median (Full Range)
Unit of Measure: hours
2.52
(1.00 to 5.95)
2.93
(1.00 to 4.00)
4.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide
Hide Description Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
718.4
(41.2%)
803.5
(46.9%)
5.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide
Hide Description Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population with available data
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
866.5
(44.1%)
877.9
(43.0%)
6.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide
Hide Description Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.
Time Frame Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population with available data
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
878.0
(45.1%)
7.Secondary Outcome
Title Terminal Half-life (T1/2) of Lenalidomide
Hide Description The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population with available data
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
3.26
(23.0%)
3.57
(29.6%)
8.Secondary Outcome
Title Apparent Volume of Distribution (VzF) of Lenalidomide
Hide Description Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population with available data
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
53.6
(30.9%)
58.6
(25.8%)
9.Secondary Outcome
Title Apparent Total Plasma Clearance (CL/F) of Lenalidomide
Hide Description Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population with available data
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/minute
189.8
(45.1%)
189.9
(43.0%)
10.Secondary Outcome
Title Apparent Terminal Elimination Rate Constant of Lenalidomide
Hide Description Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).
Time Frame Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population with available data
Arm/Group Title Lenalidomide: Day 1 Lenalidomide: Day 4
Hide Arm/Group Description:
Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
Overall Number of Participants Analyzed 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.213
(23.0%)
0.194
(39.0%)
11.Secondary Outcome
Title Number of Participants With a Erythroid Response
Hide Description

Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.

A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.

Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.

Time Frame Response was assessed every 28 days through Week 156.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population: all patients who had a diagnosis of low- or intermediate-1-risk MDS associated with anemia based on confirmation by the central reviewers and received at least 1 dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Erythroid responders (major or minor) 11
Major erythroid responders 11
12.Secondary Outcome
Title Time to Erythroid Response
Hide Description Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.
Time Frame From the first dose of study drug through Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: weeks
Time to erythroid response (major or minor)
2.1
(0.3 to 11.1)
Time to major erythroid response
6.3
(3.1 to 31.1)
13.Secondary Outcome
Title Duration of Erythroid Response
Hide Description Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.
Time Frame From the first dose of study drug through Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with a erythroid response
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: weeks
Duration of erythroid response (major or minor)
76.6
(8.9 to 152.0)
Duration of major erythroid response
72.1
(32.1 to 144.1)
14.Secondary Outcome
Title Change From Baseline in Hemoglobin Concentration
Hide Description Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.
Time Frame Baseline and from Day1 until the maximum observed value (up to 155 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with a erythroid response
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: g/dL
Baseline concentration
7.0
(4.7 to 9.1)
Maximum concentration during study
13.1
(10.7 to 15.8)
Change from Baseline to maximum value
6.0
(2.7 to 11.1)
15.Secondary Outcome
Title Number of Participants With a Neutrophil Response
Hide Description

Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.

A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period.

Time Frame Response was assessed every 28 days through Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with Baseline neutrophil count < 1,500/mm^3.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Major response 1
Minor response 0
16.Secondary Outcome
Title Number of Participants With a Platelet Response
Hide Description

Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 30,000/mm^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.

Minor response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 50% increase in platelet count with an absolute increase > 10,000/mm^3 and < 30,000/mm^3 sustained for consecutive 56 days during the treatment period.

Time Frame Response was assessed every 28 days through Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with a Baseline platelet count of < 100,000/mm^3 or who were platelet-transfusion dependent at Baseline. There were no patients with platelet count of < 100,000/mm3 or who were platelet-transfusion dependent at Baseline, and thus platelet response was not evaluated.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Number of Participants With a Cytogenetic Response
Hide Description

Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.

A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period.

Time Frame Response was assessed every 12 weeks through Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Major response 1
Minor response 5
18.Secondary Outcome
Title Change From Baseline in Percentage of Bone Marrow Erythroblasts
Hide Description Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.
Time Frame Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with available bone marrow specimens.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Percentage of Bone Marrow Erythroblasts
Change from Baseline at the end of Cycle 3
36.5
(-12.0 to 51.0)
Change from Baseline at the end of Cycle 6
21.5
(-5.0 to 56.0)
19.Secondary Outcome
Title Percentage of Bone Marrow Myeloblasts
Hide Description Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.
Time Frame Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with available bone marrow specimens at each time point (indicated by "N").
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: Percentage of myeloblasts
Baseline (N=11)
3.77
(1.20 to 8.40)
End of Cycle 3 (N=10)
1.47
(0.01 to 4.55)
End of Cycle 6 (N=10)
1.79
(0.01 to 4.00)
20.Secondary Outcome
Title Percentage of Bone Marrow Promyelocytes
Hide Description Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.
Time Frame Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population with available bone marrow specimens at each time point (indicated by "N").
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: Percentage of promyelocytes
Baseline (N=11)
5
(0 to 13)
End of Cycle 3 (N=10)
5
(1 to 12)
End of Cycle 6 (N=10)
5
(1 to 12)
Time Frame From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description 10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   3/11 (27.27%) 
Gastrointestinal disorders   
Gastric Ulcer  1  1/11 (9.09%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/11 (9.09%) 
Infections and infestations   
Herpes Zoster  1  1/11 (9.09%) 
Influenza  1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
Spinal Compression Fracture  1  1/11 (9.09%) 
Investigations   
Liver Function Test Abnormal  1  1/11 (9.09%) 
Metabolism and nutrition disorders   
Anorexia  1  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, Version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide
Affected / at Risk (%)
Total   11/11 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  11/11 (100.00%) 
Thrombocytopenia  1  11/11 (100.00%) 
Leukopenia  1  10/11 (90.91%) 
Lymphopenia  1  8/11 (72.73%) 
Eosinophilia  1  5/11 (45.45%) 
Basophilia  1  4/11 (36.36%) 
Leukocytosis  1  1/11 (9.09%) 
Lymphadenitis  1  1/11 (9.09%) 
Lymphocytosis  1  1/11 (9.09%) 
Ear and labyrinth disorders   
Ear Discomfort  1  1/11 (9.09%) 
Endocrine disorders   
Hypothyroidism  1  2/11 (18.18%) 
Eye disorders   
Blepharitis  1  1/11 (9.09%) 
Conjunctival Haemorrhage  1  1/11 (9.09%) 
Eye Discharge  1  1/11 (9.09%) 
Vision Blurred  1  1/11 (9.09%) 
Vitreous Detachment  1  1/11 (9.09%) 
Gastrointestinal disorders   
Constipation  1  10/11 (90.91%) 
Diarrhoea  1  4/11 (36.36%) 
Abdominal Pain  1  2/11 (18.18%) 
Dental Caries  1  2/11 (18.18%) 
Enteritis  1  2/11 (18.18%) 
Gastritis  1  2/11 (18.18%) 
Abdominal Discomfort  1  1/11 (9.09%) 
Abdominal Pain Upper  1  1/11 (9.09%) 
Gingivitis  1  1/11 (9.09%) 
Haemorrhoidal Haemorrhage  1  1/11 (9.09%) 
Lip Dry  1  1/11 (9.09%) 
Oesophagitis  1  1/11 (9.09%) 
Periodontitis  1  1/11 (9.09%) 
Toothache  1  1/11 (9.09%) 
Vomiting  1  1/11 (9.09%) 
General disorders   
Dyspepsia  1  1/11 (9.09%) 
Face Oedema  1  1/11 (9.09%) 
Injection Site Erythema  1  1/11 (9.09%) 
Non-cardiac Chest Pain  1  1/11 (9.09%) 
Oedema  1  1/11 (9.09%) 
Oedema Peripheral  1  1/11 (9.09%) 
Pain  1  1/11 (9.09%) 
Pyrexia  1  1/11 (9.09%) 
Hepatobiliary disorders   
Hepatic Function Abnormal  1  1/11 (9.09%) 
Infections and infestations   
Nasopharyngitis  1  8/11 (72.73%) 
Bronchitis  1  3/11 (27.27%) 
Gastroenteritis  1  3/11 (27.27%) 
Rhinitis  1  2/11 (18.18%) 
Urinary Tract Infection  1  2/11 (18.18%) 
Acute Tonsillitis  1  1/11 (9.09%) 
Cystitis  1  1/11 (9.09%) 
Lymphadenitis Bacterial  1  1/11 (9.09%) 
Oral Herpes  1  1/11 (9.09%) 
Pharyngitis  1  1/11 (9.09%) 
Pneumonia  1  1/11 (9.09%) 
Vulvitis  1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
Spinal Compression Fracture  1  3/11 (27.27%) 
Contusion  1  3/11 (27.27%) 
Excoriation  1  1/11 (9.09%) 
Fracture  1  1/11 (9.09%) 
Tooth Fracture  1  1/11 (9.09%) 
Investigations   
Alanine Aminotransferase Increased  1  3/11 (27.27%) 
Blood Creatinine Increased  1  3/11 (27.27%) 
Fibrin Degradation Products Increased  1  3/11 (27.27%) 
Aspartate Aminotransferase Increased  1  2/11 (18.18%) 
Blood Bilirubin Increased  1  2/11 (18.18%) 
Blood Phosphorus Decreased  1  2/11 (18.18%) 
Blood Uric Acid Increased  1  2/11 (18.18%) 
Fibrin D Dimer Increased  1  2/11 (18.18%) 
Blood Alkaline Phosphatase Increased  1  1/11 (9.09%) 
Blood Lactate Dehydrogenase Increased  1  1/11 (9.09%) 
Blood Potassium Increased  1  1/11 (9.09%) 
Blood Pressure Increased  1  1/11 (9.09%) 
Blood Urea Decreased  1  1/11 (9.09%) 
Blood Urea Increased  1  1/11 (9.09%) 
International Normalised Ratio Increased  1  1/11 (9.09%) 
Mean Cell Volume Increased  1  1/11 (9.09%) 
Protein Total Increased  1  1/11 (9.09%) 
Metabolism and nutrition disorders   
Dehydration  1  1/11 (9.09%) 
Hypoalbuminaemia  1  1/11 (9.09%) 
Hypokalaemia  1  1/11 (9.09%) 
Hypophosphataemia  1  1/11 (9.09%) 
Iron Deficiency  1  1/11 (9.09%) 
Vitamin B12 Deficiency  1  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  4/11 (36.36%) 
Muscle Spasms  1  3/11 (27.27%) 
Arthralgia  1  2/11 (18.18%) 
Bone Pain  1  1/11 (9.09%) 
Musculoskeletal Chest Pain  1  1/11 (9.09%) 
Myalgia  1  1/11 (9.09%) 
Myalgia Intercostal  1  1/11 (9.09%) 
Osteoarthritis  1  1/11 (9.09%) 
Osteoporosis  1  1/11 (9.09%) 
Periarthritis  1  1/11 (9.09%) 
Spinal Osteoarthritis  1  1/11 (9.09%) 
Nervous system disorders   
Cervicobrachial Syndrome  1  1/11 (9.09%) 
Headache  1  1/11 (9.09%) 
Psychiatric disorders   
Insomnia  1  1/11 (9.09%) 
Tension  1  1/11 (9.09%) 
Renal and urinary disorders   
Dysuria  1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/11 (9.09%) 
Rhinorrhoea  1  1/11 (9.09%) 
Upper Respiratory Tract Inflammation  1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
Rash  1  8/11 (72.73%) 
Pruritus  1  5/11 (45.45%) 
Dermatitis Contact  1  4/11 (36.36%) 
Eczema  1  2/11 (18.18%) 
Acute Febrile Neutrophilic Dermatosis  1  1/11 (9.09%) 
Dry Skin  1  1/11 (9.09%) 
Erythema  1  1/11 (9.09%) 
Erythema Multiforme  1  1/11 (9.09%) 
Vascular disorders   
Hypertension  1  4/11 (36.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, Version 10.0
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 vary; 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: Associate Director, Clinical Trials 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: NCT00812968     History of Changes
Other Study ID Numbers: CC-5013-MDS-007
First Submitted: December 17, 2008
First Posted: December 22, 2008
Results First Submitted: September 30, 2013
Results First Posted: December 17, 2013
Last Update Posted: December 12, 2016