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Trial record 55 of 2511 for:    "Plasma Cell Neoplasm"

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction (PrE1003)

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ClinicalTrials.gov Identifier: NCT00790842
Recruitment Status : Terminated (Slow enrollment)
First Posted : November 14, 2008
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
PrECOG, LLC.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Plasma Cell Neoplasm
Interventions Drug: Lenalidomide
Drug: Dexamethasone
Drug: Anticoagulants
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group C Lenalidomide 15 mg 3x/Week Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C, Lenalidomide 25 mg/Day
Hide Arm/Group Description Creatinine clearance (CrCl) of 30 - 60 mL/min. Lenalidomide 10 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 15 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 25 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide 15 mg/every other day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of <30 mL/min, not on dialysis. Treated with lenalidomide 25 mg every other day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 15 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 25 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.

Creatinine clearance of 30 - 60 mL/min and on dialysis. Treated with lenalidomide 15 mg 3 days/week for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.

Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 15 mg 3 times per week, dexamethasone and anticoagulant Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 10 mg/day, dexamethasone, and anticoagulants Creatinine clearance < 30 mL/min and on dialysis, treated with lenalidomide at 25 mg/day, dexamethasone, and anticoagulants
Period Title: Dose Level 1
Started 6 0 0 3 0 0 0 3 0 0 0
Began Treatment 6 0 0 3 0 0 0 3 0 0 0
Completed [1] 3 0 0 1 0 0 0 1 0 0 0
Not Completed 3 0 0 2 0 0 0 2 0 0 0
Reason Not Completed
Adverse Event             1             0             0             2             0             0             0             1             0             0             0
Physician Decision             1             0             0             0             0             0             0             1             0             0             0
Withdrawal by Subject             1             0             0             0             0             0             0             0             0             0             0
[1]
Treated until disease progression
Period Title: Dose Level 2
Started 0 3 0 0 3 0 0 0 3 0 0
Began Treatment 0 3 0 0 3 0 0 0 3 0 0
Completed 0 0 0 0 2 0 0 0 1 0 0
Not Completed 0 3 0 0 1 0 0 0 2 0 0
Reason Not Completed
Death             0             1             0             0             1             0             0             0             0             0             0
Physician Decision             0             1             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             0             0             0             0             0             0             0             0             0
Intercurrent Illness/Other Treatment             0             0             0             0             0             0             0             0             2             0             0
Period Title: Dose Level 3
Started 0 0 7 0 0 3 0 0 0 3 0
Began Treatment 0 0 6 0 0 3 0 0 0 3 0
Completed 0 0 2 0 0 2 0 0 0 1 0
Not Completed 0 0 5 0 0 1 0 0 0 2 0
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             3             0             0             0             0             0             0             2             0
Intercurrent Illness/Alternative Therapy             0             0             0             0             0             1             0             0             0             0             0
Ineligible/Withdrew before Treatment             0             0             1             0             0             0             0             0             0             0             0
Period Title: Dose Level 4
Started 0 0 0 0 0 0 8 0 0 0 5
Began Treatment 0 0 0 0 0 0 8 0 0 0 5
Completed 0 0 0 0 0 0 6 0 0 0 3
Not Completed 0 0 0 0 0 0 2 0 0 0 2
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0             0             0
Physician Decision             0             0             0             0             0             0             1             0             0             0             1
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             1
Period Title: Expansion Cohort
Started 0 0 14 0 0 0 2 0 0 0 0
Began Treatment 0 0 14 0 0 0 2 0 0 0 0
Completed 0 0 7 0 0 0 1 0 0 0 0
Not Completed 0 0 7 0 0 0 1 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0             0             0
Death             0             0             2             0             0             0             0             0             0             0             0
Physician Decision             0             0             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             3             0             0             0             0             0             0             0             0
Study Closure             0             0             1             0             0             0             0             0             0             0             0
Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis Total
Hide Arm/Group Description

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

Total of all reporting groups
Overall Number of Baseline Participants 29 19 14 62
Hide Baseline Analysis Population Description
Eligible, treated patients
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 29 participants 19 participants 14 participants 62 participants
73
(68 to 78)
72
(62 to 79)
64
(57 to 70)
71.5
(64 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 19 participants 14 participants 62 participants
Female
13
  44.8%
12
  63.2%
6
  42.9%
31
  50.0%
Male
16
  55.2%
7
  36.8%
8
  57.1%
31
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 19 participants 14 participants 62 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
29
 100.0%
18
  94.7%
14
 100.0%
61
  98.4%
Unknown or Not Reported
0
   0.0%
1
   5.3%
0
   0.0%
1
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 19 participants 14 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   7.1%
1
   1.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.3%
2
  10.5%
3
  21.4%
8
  12.9%
White
26
  89.7%
16
  84.2%
10
  71.4%
52
  83.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.3%
0
   0.0%
1
   1.6%
Creatinine Clearance   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mL/min
Number Analyzed 29 participants 19 participants 14 participants 62 participants
42.6
(37.0 to 51.2)
22.8
(15.7 to 25.4)
11.5
(9.7 to 17.2)
27.4
(15.7 to 42.1)
[1]
Measure Description: Serum creatinine clearance, mL/minute
1.Primary Outcome
Title Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
Hide Description

Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:

  • Grade 3 or higher neutropenia with fever ≥38.5 degrees C
  • Grade 4 neutropenia ≥7 days
  • Grade 4 or higher thrombocytopenia
  • Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
Time Frame First cycle of therapy (28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated during the dose finding phase of the study
Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group C Lenalidomide 15 mg 3x/Week Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
Hide Arm/Group Description:
CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants.
CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
CrCl < 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
Overall Number of Participants Analyzed 6 3 6 3 3 3 8 3 3 3 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Lenalidomide 10 mg/Day, Group A Lenalidomide 15 mg/Day, Group A Lenalidomide 25 mg/Day
Comments Recommended Phase 2 dose for Group A
Type of Statistical Test Other
Comments Recommended Phase 2 dose for Group A
Method of Estimation Estimation Parameter Dose in milligrams per day
Estimated Value 25
Estimation Comments Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B Lenalidomide 15 mg/2 Days, Group B Lenalidomide 25 mg/2 Days, Group B Lenalidomide 15 mg/Day, Group B Lenalidomide 25 mg/Day
Comments Recommended phase 2 dose for patients in Group B
Type of Statistical Test Other
Comments Recommended phase 2 dose for patients in Group B
Method of Estimation Estimation Parameter Dose in milligrams/day
Estimated Value 25
Estimation Comments Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/minute who are not on dialysis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group C Lenalidomide 15 mg 3x/Week, Group C Lenalidomide 10 mg/Day, Group C Lenalidomide 15 mg/Day, Group C Lenalidomide 25 mg/Day
Comments Recommended phase 2 dose for Group C
Type of Statistical Test Other
Comments Recommended phase 2 dose for Group C
Method of Estimation Estimation Parameter Lenalidomide dose in mg/day
Estimated Value 25
Estimation Comments Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/min who are receiving dialysis
2.Primary Outcome
Title Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
Hide Description Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components
Time Frame 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated at the recommended phase II dose
Arm/Group Title Group A CrCl 30-60 mL/Min Group B CrCL<30 mL/Min, Not on Dialysis Group C CrCL<30 mL/Min and on Dialysis
Hide Arm/Group Description:
Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Overall Number of Participants Analyzed 20 10 5
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
60.0
(39.4 to 78.3)
60.0
(30.4 to 85.0)
20.0
(1.0 to 65.7)
3.Secondary Outcome
Title Overall Survival Time
Hide Description Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
Time Frame 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, treated patients
Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
Hide Arm/Group Description:

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

Overall Number of Participants Analyzed 29 19 14
Median (90% Confidence Interval)
Unit of Measure: months
20.8
(11.0 to 42.1)
20.0
(10.4 to 34.2)
NA [1] 
(10.4 to NA)
[1]
Insufficient observations to estimate median or upper confidence limit
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.
Time Frame 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated at the recommended phase II dose who experienced a response to treatment
Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
Hide Arm/Group Description:
Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
Overall Number of Participants Analyzed 12 6 1
Median (Inter-Quartile Range)
Unit of Measure: Months
21.8
(14.4 to 34.8)
8.4
(7.9 to 9.4)
25.4
(25.4 to 25.4)
5.Secondary Outcome
Title Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
Hide Description The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
Time Frame 56 months
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Hide Analysis Population Description
All patients who started treatment
Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/Week Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
Hide Arm/Group Description:
CrCl 30-60 mL/min, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl 30-60 mL/min, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
CrCl < 30 mL/min, not on dialysis. Lenalidomide days 15 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, not on dialysis. Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose.
CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg 3 times a week from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, on dialysis, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
CrCl < 30 mL/min, on dialysis, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
Overall Number of Participants Analyzed 6 3 6 14 3 3 3 8 2 3 3 3 5
Measure Type: Number
Unit of Measure: participants
None 3 1 1 1 1 1 0 1 0 3 0 0 2
Grade 1 0 0 1 4 0 0 1 1 1 0 1 2 0
Grade 2 2 0 0 3 0 0 1 2 0 0 0 0 0
Grade 3 1 1 4 6 1 1 1 3 0 0 1 1 3
Grade 4 0 1 0 0 1 1 0 1 1 0 0 0 0
Grade 5 0 0 0 0 0 0 0 0 0 0 1 0 0
6.Secondary Outcome
Title Renal Function Over Time
Hide Description To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.
Time Frame 56 months
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Hide Analysis Population Description
This outcome was not analyzed because the dose increase was not implemented.
Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
Hide Arm/Group Description:

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Pharmacokinetics of Lenalidomide in Impaired Renal Function
Hide Description To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only).
Time Frame 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
As only 1 patient was enrolled from Mayo Clinic during the Phase II component of the study, samples were neither collected nor analyzed for this endpoint.
Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
Hide Arm/Group Description:

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.
Time Frame 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated at the recommended phase II dose
Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
Hide Arm/Group Description:

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II.

Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.

Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

Overall Number of Participants Analyzed 20 10 5
Median (90% Confidence Interval)
Unit of Measure: Months
12.6
(6.5 to 25.1)
11.4
(10.4 to 14.5)
NA [1] 
(2.1 to NA)
[1]
Median and upper confidence limit are not estimable due to small sample size
Time Frame Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
Adverse Event Reporting Description Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of treatment.
 
Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
Hide Arm/Group Description CrCl 30-60 mL/min. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg three times weekly for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
All-Cause Mortality
Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   1/3 (33.33%)   0/6 (0.00%)   4/14 (28.57%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/8 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   1/3 (33.33%)   1/3 (33.33%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   2/3 (66.67%)   5/6 (83.33%)   10/14 (71.43%)   3/3 (100.00%)   3/3 (100.00%)   1/3 (33.33%)   5/8 (62.50%)   1/2 (50.00%)   2/3 (66.67%)   3/3 (100.00%)   3/3 (100.00%)   4/5 (80.00%) 
Blood and lymphatic system disorders                           
Anemia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  3/14 (21.43%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Other (Eosinophilia)  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Pancytopenia)  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Thrombocytopenia)  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Cardiac disorders                           
Atrioventricular Block Complete  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Heart Failure  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Myocardial infarction  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Ear and labyrinth disorders                           
Middle ear inflammation  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Eye disorders                           
Cataract  1  1/6 (16.67%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Vitreous hemorrhage  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders                           
Abdominal Distension  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Ascites  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Colitis  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Constipation  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Diarrhea  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Dysphagia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Gastric hemorrhage  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Intra-abdominal hemorrhage  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pancreatitis  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Small intestinal obstruction  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Diverticulitis)  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
General disorders                           
Death  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Multi-organ failure  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Hepatobiliary disorders                           
Other (Hepatic cirrhosis)  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Hepatobiliary disease)  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Infections and infestations                           
Abdominal Infection  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Lung infection  1  1/6 (16.67%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Sepsis  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Upper respiratory infection  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Urinary tract infection  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Cellulitis)  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Clostridial infection)  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Localized infection)  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications                           
Fall  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Fracture  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Investigations                           
Creatinine Increased  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
INR increased  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Lymphocyte count decreased  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Neutrophil count decreased  1  1/6 (16.67%)  1/3 (33.33%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Platelet count decreased  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Weight gain  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
White blood cell count decreased  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Metabolism and nutrition disorders                           
Anorexia  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Dehydration  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypercalcemia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyperglycemia  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyperkalemia  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Hypoalbuminemia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Hypocalcemia  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypokalemia  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  2/14 (14.29%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyponatremia  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypophosphatemia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders                           
Generalized muscle weakness  1  0/6 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  2/14 (14.29%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                           
Other (pulmonary mass)  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Nervous system disorders                           
Memory impairment  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Peripheral motor neuropathy  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Somnolence  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Syncope  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Tremor  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (post-traumatic pain)  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Psychiatric disorders                           
Agitation  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Delirium  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Depression  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Insomnia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Renal and urinary disorders                           
Acute kidney injury  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  3/14 (21.43%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Chronic kidney injury  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Cystitis noninfective  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Uremic encephalopathy)  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders                           
Hiccups  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Vascular disorders                           
Hypotension  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Peripheral ischemia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Thromboembolic Event  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Vasculitis  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
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%
Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   2/3 (66.67%)   6/6 (100.00%)   14/14 (100.00%)   1/3 (33.33%)   3/3 (100.00%)   3/3 (100.00%)   8/8 (100.00%)   2/2 (100.00%)   1/3 (33.33%)   2/3 (66.67%)   3/3 (100.00%)   4/5 (80.00%) 
Blood and lymphatic system disorders                           
Anemia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  2/14 (14.29%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Cardiac disorders                           
Atrial fibrillation  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Eye disorders                           
Blurred vision  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Watering eyes  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders                           
Constipation  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  3/14 (21.43%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Diarrhea  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Fecal incontinence  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Mucositis oral  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Infections and infestations                           
Upper respiratory infection  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  3/14 (21.43%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Injury, poisoning and procedural complications                           
Bruising  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Fall  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Laceration)  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Investigations                           
Alkaline phosphatase increased  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Lymphocyte count decreased  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Neutrophil count decreased  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Platelet count decreased  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Weight loss  1  0/6 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  2/14 (14.29%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
White blood cell count decreased  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/14 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Metabolism and nutrition disorders                           
Anorexia  1  0/6 (0.00%)  1/3 (33.33%)  3/6 (50.00%)  4/14 (28.57%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Dehydration  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyperglycemia  1  0/6 (0.00%)  1/3 (33.33%)  3/6 (50.00%)  2/14 (14.29%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/8 (12.50%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypoalbuminemia  1  0/6 (0.00%)  1/3 (33.33%)  3/6 (50.00%)  3/14 (21.43%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypocalcemia  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  6/14 (42.86%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypokalemia  1  0/6 (0.00%)  0/3 (0.00%)  4/6 (66.67%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyponatremia  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  3/14 (21.43%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders                           
Arthralgia  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  4/14 (28.57%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Back pain  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Chest wall pain  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  3/14 (21.43%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Generalized muscle weakness  1  1/6 (16.67%)  0/3 (0.00%)  1/6 (16.67%)  5/14 (35.71%)  0/3 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Myalgia  1  0/6 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pain in extremity  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  3/14 (21.43%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Other (Muscle spasms)  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/8 (37.50%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/5 (20.00%) 
Nervous system disorders                           
Dizziness  1  0/6 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  3/14 (21.43%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Dysgeusia  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Headache  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  2/14 (14.29%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Psychiatric disorders                           
Insomnia  1  1/6 (16.67%)  1/3 (33.33%)  1/6 (16.67%)  2/14 (14.29%)  1/3 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Renal and urinary disorders                           
Urinary frequency  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders                           
Cough  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  4/14 (28.57%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Dyspnea  1  0/6 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  5/14 (35.71%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/8 (12.50%)  1/2 (50.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders                           
Dry skin  1  0/6 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/14 (7.14%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Pruritus  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Vascular disorders                           
Hypotension  1  0/6 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  2/14 (14.29%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: PrECOG Statistician
Organization: PrECOG
Phone: 978-835-3516
Responsible Party: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT00790842     History of Changes
Other Study ID Numbers: PrE1003
RV-MM-PrECOG-0394 ( Other Identifier: Celgene Protocol )
First Submitted: November 13, 2008
First Posted: November 14, 2008
Results First Submitted: July 29, 2018
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018