Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities

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: NCT00546897
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Myeloid, Acute
Intervention Drug: Lenalidomide
Enrollment 48
Recruitment Details The study opened to participant enrollment on 02/02/2007 and closed to participant enrollment on 03/04/2009.
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Period Title: Overall Study
Started 15 33
Completed 15 33
Not Completed 0 0
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Total of all reporting groups
Overall Number of Baseline Participants 15 33 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 33 participants 48 participants
71
(60 to 86)
71
(60 to 88)
71
(60 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 33 participants 48 participants
Female
4
  26.7%
12
  36.4%
16
  33.3%
Male
11
  73.3%
21
  63.6%
32
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 33 participants 48 participants
15 33 48
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 33 participants 48 participants
0 10 16 26
1 4 13 17
2 1 4 5
[1]
Measure Description:
  • 0 Fully active, able to carry on all pre-disease performance without restriction.
  • 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
  • 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
  • 3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
  • 4 Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
  • 5 Dead
Cytogenetic Risk Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 33 participants 48 participants
Intermediate 13 18 31
Unfavorable 2 13 15
Unknown 0 2 2
1.Primary Outcome
Title Complete Remission Rate (CRm + CRi + CRc)
Hide Description

CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.

CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.

Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).

Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
CRm 0 3
CRi 0 4
CRc 1 3
2.Secondary Outcome
Title Safety and Tolerability (Removal From Study Due to Adverse Events)
Hide Description Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting
Time Frame 4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 15 33
Measure Type: Number
Unit of Measure: participants
1 8
3.Secondary Outcome
Title Response Rate (RR)
Hide Description

RR = as patients obtaining any response (CRm + CRc +CRi + PR).

CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.

CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).

Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.

Partial remission (PR): Requires

Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
CRm 0 3
CRc 1 3
CRi 0 4
PR 1 0
4.Secondary Outcome
Title Morphologic Leukemia Free State
Hide Description Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.
Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
1 10
5.Secondary Outcome
Title Morphologic Complete Remission Rate (CRm)
Hide Description CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.
Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
0 3
6.Secondary Outcome
Title Cytogenetics CR Rate (CRc)
Hide Description Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).
Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
1 3
7.Secondary Outcome
Title CR With Complete Blood Counts (CRi) Rate
Hide Description CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
0 4
8.Secondary Outcome
Title Partial Remission Rate (PR)
Hide Description Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.
Time Frame After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description

9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.

23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2.

Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: participants
1 0
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 were not analyzed for overall survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 0 33
Median (95% Confidence Interval)
Unit of Measure: months
4
(3 to 9)
10.Secondary Outcome
Title Event Free Survival (EFS)
Hide Description Event free survival: Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.
Time Frame 2 years
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 were not analyzed for progression-free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 0 33
Median (95% Confidence Interval)
Unit of Measure: months
2
(2 to 3)
12.Secondary Outcome
Title Relapse Free Survival (RFS) for Complete Responders
Hide Description This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 were not analyzed for relapse free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 0 10
Median (95% Confidence Interval)
Unit of Measure: months
10 [1] 
(2 to NA)
[1]
NA = this is NE (not estimated). The upper bound of the 95% confidence interval was not estimable using the Kaplan-Meier survival curve
13.Secondary Outcome
Title Duration of CR for Complete Responders
Hide Description Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 were not analyzed for duration of remission because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

Overall Number of Participants Analyzed 0 10
Median (Full Range)
Unit of Measure: months
10
(1 to 17)
14.Secondary Outcome
Title Changes in NK Cell Number and Function
Hide Description Peripheral blood mononuclear cells (PBMC) will be viably cryopreserved from patients at baseline (pre-therapy, newly diagnosed AML), during lenalidomide therapy, and posttherapy. Following sample collection, PBMC will be thawed, and flow cytometry will be performed to assess NK cell number (CD56+CD3-), subsets, and phenotype utilizing the Siteman Cancer Center Flow Cytometry / Cell Sorting Core. In addition, NK cell function will be assessed in flow based killing assays using PBMC (containing NK cells) as effectors and NK sensitive cell lines (K562) and/or autologous leukemic blasts as target cells. Thus, analyzing these parameters in patients before, during, and after therapy will provide a comprehensive evaluation of the ability of lenalidomide to modulate NK cells in patients in vivo.
Time Frame Baseline, during therapy, and posttherapy
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Gene Expression Profiles of Bone Marrow and Peripheral Blood
Hide Description RNA will be made from total bone marrow cells for labeling and evaluations by RNA profiling. Cellular RNA and corresponding biotinylated cRNA targets will be prepared and hybridized with Affymetrix GeneChip® microarrays within the Multiplexed Gene Analysis SCC Core (Dr. Mark Watson, Director). Microarray data (and eventually corresponding gene sequence data) will be integrated an analyzed with state-of-the-art software packages. The pre- and post-treatment RNA profiling studies will be used as a discovery tool. Patterns of gene expression before and after lenalidomide therapy will be compared within each patient’s sample to identify genes with altered expression after lenalidomide therapy. In addition, supervised algorithms will be sued to identify genes that can potentially predict clinical outcome and response to lenalidomide therapy.
Time Frame Pre and post treatment
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Plasma Proteins Via Proteomics
Hide Description Proteomic analysis will be performed within the Siteman Cancer Center proteomics core on pre- and post-treatment plasma samples. This pilot proteomic study will identify candidate proteins of interest with altered expression after treatment with lenalidomide. This approach will provide an unbiased method to assess global changes in serum proteins following lenalidomide therapy.
Time Frame Pre and post treatment
Outcome Measure Data Not Reported
Time Frame Adverse events were collected from the start of treatment until 30 days following the completion of treatment. Cohort 1 median duration of treatment was 65 days (5-530). Cohort 2 median duration of treatment was 65 days (3-413).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description

Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).

If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles.

Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.

Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy.

All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   10/15 (66.67%)   25/33 (75.76%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  6/15 (40.00%)  12/33 (36.36%) 
Hemoglobin  1  0/15 (0.00%)  1/33 (3.03%) 
Cardiac disorders     
Syncope  1  0/15 (0.00%)  3/33 (9.09%) 
Myocardial infarction  1  0/15 (0.00%)  1/33 (3.03%) 
Chest pain  1  0/15 (0.00%)  2/33 (6.06%) 
Cardiac ischemia  1  0/15 (0.00%)  1/33 (3.03%) 
Left ventricular diastolic dysfunction  1  0/15 (0.00%)  1/33 (3.03%) 
Gastrointestinal disorders     
Nausea  1  1/15 (6.67%)  1/33 (3.03%) 
Vomiting  1  1/15 (6.67%)  2/33 (6.06%) 
Diarrhea  1  1/15 (6.67%)  0/33 (0.00%) 
Dehydration  1  1/15 (6.67%)  2/33 (6.06%) 
Dysphagia  1  0/15 (0.00%)  2/33 (6.06%) 
Splenic infarction  1  0/15 (0.00%)  1/33 (3.03%) 
Constipation  1  0/15 (0.00%)  1/33 (3.03%) 
Mucositis  1  0/15 (0.00%)  2/33 (6.06%) 
Tonsil fistula  1  0/15 (0.00%)  1/33 (3.03%) 
C. difficile colitis  1  0/15 (0.00%)  1/33 (3.03%) 
Upper GI hemorrhage  1  0/15 (0.00%)  1/33 (3.03%) 
Lower GI hemorrhage  1  0/15 (0.00%)  1/33 (3.03%) 
General disorders     
Death due to progressive disease  1  3/15 (20.00%)  6/33 (18.18%) 
Fatigue  1  0/15 (0.00%)  3/33 (9.09%) 
Hepatobiliary disorders     
Liver dysfunction  1  0/15 (0.00%)  1/33 (3.03%) 
Infections and infestations     
Pneumonia  1  2/15 (13.33%)  9/33 (27.27%) 
Staph hominis bacteremia infection  1  1/15 (6.67%)  0/33 (0.00%) 
Catheter line infection  1  1/15 (6.67%)  0/33 (0.00%) 
Opportunistic fungal infection - death  1  1/15 (6.67%)  0/33 (0.00%) 
Gram-cocci infection  1  1/15 (6.67%)  0/33 (0.00%) 
Streptococcus bacteremia infection  1  0/15 (0.00%)  1/33 (3.03%) 
E. Coli infection  1  0/15 (0.00%)  2/33 (6.06%) 
Sepsis  1  0/15 (0.00%)  1/33 (3.03%) 
Oral candidiasis  1  0/15 (0.00%)  1/33 (3.03%) 
Sinusitis  1  0/15 (0.00%)  1/33 (3.03%) 
Coryn bacterium miutissimum sepsis  1  0/15 (0.00%)  1/33 (3.03%) 
Staphylcoccus epidermidis sepsis  1  0/15 (0.00%)  1/33 (3.03%) 
Gram positive sepsis  1  0/15 (0.00%)  1/33 (3.03%) 
Coagulase negative staphylococcus sepsis  1  0/15 (0.00%)  1/33 (3.03%) 
Urinary tract infection  1  0/15 (0.00%)  1/33 (3.03%) 
Investigations     
Hypernatremia  1  0/15 (0.00%)  1/33 (3.03%) 
Hypokalemia  1  0/15 (0.00%)  1/33 (3.03%) 
Neutrophils  1  0/15 (0.00%)  2/33 (6.06%) 
Platelets  1  0/15 (0.00%)  1/33 (3.03%) 
Metabolism and nutrition disorders     
Failure to thrive  1  0/15 (0.00%)  1/33 (3.03%) 
Anorexia  1  0/15 (0.00%)  3/33 (9.09%) 
Musculoskeletal and connective tissue disorders     
Gouty arthritis  1  1/15 (6.67%)  0/33 (0.00%) 
Lower extremity weakness  1  1/15 (6.67%)  2/33 (6.06%) 
Back pain  1  0/15 (0.00%)  1/33 (3.03%) 
Nervous system disorders     
Headache  1  1/15 (6.67%)  0/33 (0.00%) 
Death due to CNS hemorrhage  1  1/15 (6.67%)  0/33 (0.00%) 
Subdural hematoma  1  0/15 (0.00%)  1/33 (3.03%) 
Psychiatric disorders     
Mental status  1  0/15 (0.00%)  1/33 (3.03%) 
Renal and urinary disorders     
Death due to acute renal failure  1  0/15 (0.00%)  1/33 (3.03%) 
Renal failure  1  0/15 (0.00%)  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/15 (6.67%)  0/33 (0.00%) 
Hypoxia  1  0/15 (0.00%)  2/33 (6.06%) 
Pulmonary embolism  1  0/15 (0.00%)  1/33 (3.03%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/15 (0.00%)  1/33 (3.03%) 
Petichae  1  0/15 (0.00%)  1/33 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   33/33 (100.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  5/15 (33.33%)  14/33 (42.42%) 
Hemoglobin  1  10/15 (66.67%)  22/33 (66.67%) 
Lymphocele  1  0/15 (0.00%)  1/33 (3.03%) 
Cardiac disorders     
Atrial fibrillation  1  0/15 (0.00%)  4/33 (12.12%) 
Cardiac ischemia  1  0/15 (0.00%)  2/33 (6.06%) 
Cardiopulmonary arrest  1  1/15 (6.67%)  0/33 (0.00%) 
Chest pain  1  2/15 (13.33%)  5/33 (15.15%) 
Hypertension  1  0/15 (0.00%)  6/33 (18.18%) 
Hypotension  1  1/15 (6.67%)  6/33 (18.18%) 
Left ventricular systolic dysfunction  1  1/15 (6.67%)  1/33 (3.03%) 
Palpitations  1  1/15 (6.67%)  0/33 (0.00%) 
Sinus bradycardia  1  0/15 (0.00%)  1/33 (3.03%) 
Sinus tachycardia  1  1/15 (6.67%)  7/33 (21.21%) 
Supraventricular arrhythmia  1  1/15 (6.67%)  0/33 (0.00%) 
Ventricular tachycardia  1  0/15 (0.00%)  1/33 (3.03%) 
Endocrine disorders     
Hypothyroidism  1  1/15 (6.67%)  0/33 (0.00%) 
Eye disorders     
Blurred vision  1  0/15 (0.00%)  3/33 (9.09%) 
Eye hemorrhage  1  0/15 (0.00%)  2/33 (6.06%) 
Floaters  1  0/15 (0.00%)  1/33 (3.03%) 
Gastrointestinal disorders     
Abdominal pain  1  1/15 (6.67%)  7/33 (21.21%) 
Constipation  1  3/15 (20.00%)  12/33 (36.36%) 
Dehydration  1  0/15 (0.00%)  4/33 (12.12%) 
Dental abscess  1  0/15 (0.00%)  1/33 (3.03%) 
Dental pain  1  0/15 (0.00%)  1/33 (3.03%) 
Diarrhea  1  3/15 (20.00%)  12/33 (36.36%) 
Diverticulosis  1  1/15 (6.67%)  0/33 (0.00%) 
Dry mouth  1  1/15 (6.67%)  4/33 (12.12%) 
Dysphagia  1  0/15 (0.00%)  4/33 (12.12%) 
Esophagitis  1  1/15 (6.67%)  0/33 (0.00%) 
Flatulence  1  0/15 (0.00%)  1/33 (3.03%) 
Hard palate ulcer  1  0/15 (0.00%)  1/33 (3.03%) 
Hemorrhoid pain  1  0/15 (0.00%)  1/33 (3.03%) 
Incontinence - anal  1  1/15 (6.67%)  5/33 (15.15%) 
Lower GI NOS hemorrhage  1  0/15 (0.00%)  1/33 (3.03%) 
Mucositis  1  1/15 (6.67%)  11/33 (33.33%) 
Nausea  1  1/15 (6.67%)  9/33 (27.27%) 
Peridontal - mandible swelling  1  1/15 (6.67%)  0/33 (0.00%) 
Periodontal - poor dentition  1  1/15 (6.67%)  2/33 (6.06%) 
Rectal hemorrhage  1  0/15 (0.00%)  2/33 (6.06%) 
Splenic infarction  1  0/15 (0.00%)  1/33 (3.03%) 
Taste alteration  1  0/15 (0.00%)  2/33 (6.06%) 
Tonsil fistula  1  0/15 (0.00%)  1/33 (3.03%) 
Vomiting  1  1/15 (6.67%)  6/33 (18.18%) 
General disorders     
Chills  1  1/15 (6.67%)  5/33 (15.15%) 
Fatigue  1  8/15 (53.33%)  17/33 (51.52%) 
Fever (no infection)  1  1/15 (6.67%)  3/33 (9.09%) 
Generalized pain  1  0/15 (0.00%)  7/33 (21.21%) 
Inguinal hernia  1  0/15 (0.00%)  1/33 (3.03%) 
Neck nodule  1  0/15 (0.00%)  1/33 (3.03%) 
Progressive disease  1  2/15 (13.33%)  5/33 (15.15%) 
Sweating  1  0/15 (0.00%)  1/33 (3.03%) 
Hepatobiliary disorders     
Liver dysfunction  1  0/15 (0.00%)  1/33 (3.03%) 
Immune system disorders     
Allergic reaction/hypersensitivity  1  1/15 (6.67%)  1/33 (3.03%) 
Infections and infestations     
Infection w/neutropenia - cellulitis  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - clostridium difficile  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - enterococcus faecium  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - escheria coli  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - oral candidiasis  1  0/15 (0.00%)  2/33 (6.06%) 
Infection w/neutropenia - parainfluenza  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - pneumonia  1  3/15 (20.00%)  11/33 (33.33%) 
Infection w/neutropenia - polymicrobial sepsis  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - stapphylococcus  1  2/15 (13.33%)  5/33 (15.15%) 
Infection w/neutropenia - unspecified  1  2/15 (13.33%)  0/33 (0.00%) 
Infection w/neutropenia - upper respiratory  1  1/15 (6.67%)  1/33 (3.03%) 
Infection w/neutropenia - urinary tract  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/neutropenia - vaginal  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/o neutropenia - bronchitis  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/o neutropenia - catheter fungemia  1  1/15 (6.67%)  0/33 (0.00%) 
Infection w/o neutropenia - coagulase negative staphylococcus bacteremia  1  0/15 (0.00%)  2/33 (6.06%) 
Infection w/o neutropenia - middle ear  1  1/15 (6.67%)  0/33 (0.00%) 
Infection w/o neutropenia - oral candidiasis  1  0/15 (0.00%)  1/33 (3.03%) 
Infection w/o neutropenia - pneumonia  1  0/15 (0.00%)  3/33 (9.09%) 
Infection w/o neutropenia - upper respiratory  1  1/15 (6.67%)  1/33 (3.03%) 
Sinusitis  1  0/15 (0.00%)  2/33 (6.06%) 
Investigations     
Alkaline phosphatase  1  4/15 (26.67%)  10/33 (30.30%) 
Alkylosis  1  1/15 (6.67%)  0/33 (0.00%) 
Bilirubin  1  3/15 (20.00%)  12/33 (36.36%) 
Creatinine  1  2/15 (13.33%)  12/33 (36.36%) 
Edema  1  7/15 (46.67%)  11/33 (33.33%) 
Hyperglycemia  1  3/15 (20.00%)  6/33 (18.18%) 
Hyperkalemia  1  2/15 (13.33%)  3/33 (9.09%) 
Hypermagnesemia  1  1/15 (6.67%)  1/33 (3.03%) 
Hypernatremia  1  5/15 (33.33%)  5/33 (15.15%) 
Hyperuricemia  1  1/15 (6.67%)  1/33 (3.03%) 
Hypoalbuminemia  1  8/15 (53.33%)  19/33 (57.58%) 
Hypocalcemia  1  12/15 (80.00%)  21/33 (63.64%) 
Hypokalemia  1  4/15 (26.67%)  14/33 (42.42%) 
Hyponatremia  1  8/15 (53.33%)  11/33 (33.33%) 
Hypophosphatemia  1  1/15 (6.67%)  2/33 (6.06%) 
INR  1  2/15 (13.33%)  0/33 (0.00%) 
Leukocytes (WBC)  1  9/15 (60.00%)  15/33 (45.45%) 
Lymphopenia  1  1/15 (6.67%)  0/33 (0.00%) 
Neutrophils (ANC)  1  8/15 (53.33%)  11/33 (33.33%) 
Platelets  1  12/15 (80.00%)  25/33 (75.76%) 
SGOT (AST)  1  8/15 (53.33%)  12/33 (36.36%) 
SGPT (ALT)  1  12/15 (80.00%)  14/33 (42.42%) 
Weight loss  1  0/15 (0.00%)  1/33 (3.03%) 
Metabolism and nutrition disorders     
Anorexia  1  0/15 (0.00%)  11/33 (33.33%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/15 (6.67%)  0/33 (0.00%) 
Back pain  1  1/15 (6.67%)  6/33 (18.18%) 
Back spasms  1  0/15 (0.00%)  1/33 (3.03%) 
Bone pain  1  1/15 (6.67%)  0/33 (0.00%) 
Chest wall pain  1  1/15 (6.67%)  1/33 (3.03%) 
Feet pain  1  0/15 (0.00%)  1/33 (3.03%) 
Flank pain  1  1/15 (6.67%)  1/33 (3.03%) 
Hand pain  1  0/15 (0.00%)  1/33 (3.03%) 
Knee pain  1  0/15 (0.00%)  1/33 (3.03%) 
Lower back pain  1  1/15 (6.67%)  1/33 (3.03%) 
Muscle pain  1  0/15 (0.00%)  1/33 (3.03%) 
Muscle weakness - generalized  1  0/15 (0.00%)  3/33 (9.09%) 
Muscle weakness - lower extremity  1  1/15 (6.67%)  1/33 (3.03%) 
Neck pain  1  0/15 (0.00%)  1/33 (3.03%) 
Rib pain  1  0/15 (0.00%)  2/33 (6.06%) 
Shoulder pain  1  1/15 (6.67%)  1/33 (3.03%) 
Spinal stenosis  1  1/15 (6.67%)  0/33 (0.00%) 
Upper extremity pain  1  1/15 (6.67%)  0/33 (0.00%) 
Nervous system disorders     
CNS hemorrhage  1  0/15 (0.00%)  1/33 (3.03%) 
Dizziness  1  0/15 (0.00%)  5/33 (15.15%) 
Headache  1  0/15 (0.00%)  3/33 (9.09%) 
Sensory neuropathy  1  0/15 (0.00%)  4/33 (12.12%) 
Syncope  1  0/15 (0.00%)  4/33 (12.12%) 
Tingling in extremities  1  0/15 (0.00%)  2/33 (6.06%) 
Tremors  1  0/15 (0.00%)  1/33 (3.03%) 
Psychiatric disorders     
Confusion  1  0/15 (0.00%)  4/33 (12.12%) 
Insomnia  1  1/15 (6.67%)  1/33 (3.03%) 
Mood alteration - agitation  1  0/15 (0.00%)  1/33 (3.03%) 
Mood alteration - anxiety  1  0/15 (0.00%)  2/33 (6.06%) 
Mood alteration - depression  1  1/15 (6.67%)  1/33 (3.03%) 
Psychosis - hallucinations  1  0/15 (0.00%)  1/33 (3.03%) 
Renal and urinary disorders     
Cystitis  1  0/15 (0.00%)  1/33 (3.03%) 
Renal failure  1  0/15 (0.00%)  2/33 (6.06%) 
Urinary frequency  1  0/15 (0.00%)  1/33 (3.03%) 
Urinary incontinence  1  1/15 (6.67%)  4/33 (12.12%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/15 (33.33%)  10/33 (30.30%) 
Dyspnea  1  8/15 (53.33%)  13/33 (39.39%) 
Hiccups  1  1/15 (6.67%)  0/33 (0.00%) 
Hypoxia  1  0/15 (0.00%)  6/33 (18.18%) 
Nose bleed  1  1/15 (6.67%)  4/33 (12.12%) 
Pleural effusion  1  0/15 (0.00%)  1/33 (3.03%) 
Respiratory failure  1  0/15 (0.00%)  2/33 (6.06%) 
Sinus congestion  1  1/15 (6.67%)  4/33 (12.12%) 
Sinus drainage  1  3/15 (20.00%)  0/33 (0.00%) 
Throat pain  1  2/15 (13.33%)  3/33 (9.09%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/15 (6.67%)  0/33 (0.00%) 
Actinic keratosis  1  0/15 (0.00%)  2/33 (6.06%) 
Decubitus  1  0/15 (0.00%)  1/33 (3.03%) 
Dry skin  1  0/15 (0.00%)  1/33 (3.03%) 
Erythema  1  1/15 (6.67%)  1/33 (3.03%) 
Pruritis  1  2/15 (13.33%)  1/33 (3.03%) 
Rash  1  6/15 (40.00%)  18/33 (54.55%) 
Skin sore  1  1/15 (6.67%)  0/33 (0.00%) 
Surgical and medical procedures     
Biopsy site pain  1  1/15 (6.67%)  3/33 (9.09%) 
Vascular disorders     
Hematoma  1  1/15 (6.67%)  1/33 (3.03%) 
Hemorrhagic lesion  1  1/15 (6.67%)  0/33 (0.00%) 
Petechiae  1  2/15 (13.33%)  6/33 (18.18%) 
Thrombosis  1  0/15 (0.00%)  2/33 (6.06%) 
Vasculitis  1  1/15 (6.67%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ravi Vij, M.D.
Organization: Washington University School of Medicine
Phone: 314-454-8304
EMail: rvij@dom.wustl.edu
Publications:
List, AF, G Dewald, J Bennett, et al. 2005. Hematologic and Cytogenetic (CTG) Response to Lenalidomide (CC-5013) in Patients with Transfusion-Dependent (TD) Myelodysplastic Syndrome (MDS) and Chromosome 5q31.1 Deletion: Results of the Multicenter MDS-003 Study. In ASCO, Orlando, FL.
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00546897     History of Changes
Other Study ID Numbers: 06-0907
First Submitted: October 17, 2007
First Posted: October 19, 2007
Results First Submitted: September 19, 2014
Results First Posted: September 29, 2014
Last Update Posted: September 29, 2014