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A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial (EMERGE)

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ClinicalTrials.gov Identifier: NCT00737529
Recruitment Status : Completed
First Posted : August 19, 2008
Results First Posted : September 9, 2013
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mantle Cell Lymphoma
Intervention Drug: lenalidomide
Enrollment 134
Recruitment Details Participants were enrolled and treated at 42 centers in 12 countries: US/ Puerto Rico, France, Israel, Belgium, Spain, Turkey, Austria, Hungary, Italy, Colombia, Germany, and Singapore.
Pre-assignment Details All participants were required to have local histologic confirmation of Mantle Cell Lymphoma (MCL) for entry into the study.
Arm/Group Title Lenalidomide
Hide Arm/Group Description Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Period Title: Overall Study
Started 134
Completed 1 [1]
Not Completed 133
Reason Not Completed
Disease Progression             95
Adverse Event             24
Withdrawal by Subject             5
Death             4
Protocol Violation             1
Other             4
[1]
Completed equals participants ongoing on treatment at the time of the data cut-off of 30 March 2017
Arm/Group Title Lenalidomide
Hide Arm/Group Description Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Baseline Participants 134
Hide Baseline Analysis Population Description
The baseline characteristics are from the participants assesed within the intent to treat population (ITT), which included all enrolled participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants
67.2  (8.38)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
<65
49
  36.6%
≥ 65
85
  63.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
Female
26
  19.4%
Male
108
  80.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
White or Caucasian
128
  95.5%
Asian
3
   2.2%
Black or African American
1
   0.7%
Other
2
   1.5%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
0 = (Fully Active)
43
  32.1%
1 = (Restrictive but ambulatory)
73
  54.5%
2 = (Ambulatory but unable to work)
17
  12.7%
3 = (Limited self care)
1
   0.7%
4 = (Completely Disabled)
0
   0.0%
[1]
Measure Description: Eastern Cooperative Oncology Group Performance Status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
Renal function at baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
Normal (CrCl > = 60 mL/min)
99
  73.9%
Moderate Renal Insufficiency (CrCl ≥ 30 and < 60mL
28
  20.9%
Severe Renal Insufficiency (CrCl < 30 mL/min)
1
   0.7%
Missing
6
   4.5%
[1]
Measure Description: Participants with a Creatinine clearance (as calculated by the Cockcroft-Gault formula, utilizing actual body weight or ideal body weight, whichever was less) of ≥ 60 mL/min received a starting dose of 25 mg once daily. Participants with moderate renal insufficiency (ie, CrCl ≥ 30 mL/min but < 60 mL/min) received a starting dose of 10 mg lenalidomide once daily.
Duration of Mantle Cell Lymphoma  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 134 participants
<3 years 52
≥ 3 years 82
MCL (Ann Arbor) Stage at Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
I
2
   1.5%
II
5
   3.7%
III
19
  14.2%
IV
105
  78.4%
Missing
3
   2.2%
[1]
Measure Description: Ann Arbor staging is the staging system for lymphomas, both in Hodgkin's lymphoma (previously called Hodgkin's disease) and Non-Hodgkin lymphoma (NHL). Stage I = Involvement of 1 Lymph Node (LN) or extralymphatic region; Stage II = ≥ 2 LN sites on the same side of the diaphragm; Stage III = LN regions on both sides of the diaphragm; may include spleen and 1 extralymphatic organ; Stage IV = involvement of ≥ 1 extralymphatic organs with or without associated LN involvement (diffuse or disseminated).
MCL International Prognostic Index (MIPI) Score Group at Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
Low
39
  29.1%
Intermediate
51
  38.1%
High
39
  29.1%
Missing
5
   3.7%
[1]
Measure Description: A prognostic index predictive of the outcome in advanced Mantle Cell Lymphoma
Prior Bone Marrow Assessment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
Positive
55
  41.0%
Negative
52
  38.8%
Indeterminate
8
   6.0%
Missing
19
  14.2%
[1]
Measure Description: Baseline assessment of bone marrow involvement was not required per protocol; however, bone marrow biopsy and aspirate data previously conducted were collected if available.
Tumor Burden   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
High = having 1 lesion ≥ 5 cm or 3 lesions ≥ 3cm
78
  58.2%
Low = < 5cm lesions
54
  40.3%
Missing = unable to characterize
2
   1.5%
[1]
Measure Description: Defined as at least one lesion that was ≥ 5 cm in diameter or ≥ 3 lesions that were ≥ 3 cm in diameter by central radiology review.
Bulky Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
Yes
44
  32.8%
No
88
  65.7%
Missing
2
   1.5%
[1]
Measure Description: Bulky disease is defined as at least one lesion ≥ 7 cm in diameter
1.Primary Outcome
Title Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)
Hide Description Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.
Time Frame From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all enrolled participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.9
(22.26 to 38.36)
2.Primary Outcome
Title Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee
Hide Description Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.
Time Frame From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Includes participants from the ITT population who achieved a PR or better.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
16.64
(10.4219 to 29.8191)
3.Secondary Outcome
Title Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee
Hide Description The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow.
Time Frame From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all enrolled participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.0
(4.71 to 15.12)
4.Secondary Outcome
Title Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee
Hide Description Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.
Time Frame From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes participants from the ITT population who achieved a CRu or better.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: months
24.43 [1] 
(5.063 to NA)
[1]
NA indicates the upper limit of DoR of CR+CRu was not estimable at final cut-off date as of 06 April 2016 due to participants remaining on study.
5.Secondary Outcome
Title Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee
Hide Description Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.
Time Frame From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Median (95% Confidence Interval)
Unit of Measure: months
4.01
(3.6822 to 7.2329)
6.Secondary Outcome
Title Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee
Hide Description Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir
Time Frame From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Median (95% Confidence Interval)
Unit of Measure: months
5.46
(3.7479 to 9.4685)
7.Secondary Outcome
Title Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee
Hide Description Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.
Time Frame From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Median (95% Confidence Interval)
Unit of Measure: months
3.75
(2.3342 to 4.6356)
8.Secondary Outcome
Title Time to Response (TTR)
Hide Description Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.
Time Frame From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants from the ITT population who achieved a PR or better.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 40
Median (Full Range)
Unit of Measure: months
3.5
(1.7 to 15.9)
9.Secondary Outcome
Title Time to Complete Response (CR+CRu) According to the Independent Review Committee
Hide Description Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.
Time Frame From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants from the ITT population who achieved a CRu or better.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: months
3.9
(1.9 to 13.0)
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.
Time Frame From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Median (95% Confidence Interval)
Unit of Measure: months
19.50
(13.6767 to 25.5781)
11.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
Time Frame From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population received at least one dose of lenalidomide was used for all safety analysis. This was identical to the ITT population.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: participants
Any TEAE 132
Any TEAE Related to Investigational Product (IP) 118
Any TEAE Grade 3-5 AE 106
Any TEAE Grade 3 AE 101
Any TEAE Grade 4 AE 57
Any TEAE Grade 5 AE 18
Any Grade 3-5 AE Related to IP 90
Any Grade 3 AE Related to IP 88
Any Grade 4 AE Related to IP 41
Any Grade 5 AE Related to IP 2
Any TEAE Serious Adverse Event (SAE) 70
Any SAE Related to IP 30
Any TEAE Leading to Stopping of IP 28
Any Treatment Related AE Leading to Stopping IP 16
Any AE Leading to Dose Reduction 55
Any AE Leading to IP Interruption 81
Any Treatment Related AE Leading to Dose Reduction 52
Treatment Related AE Leading to IP Interruption 66
Time Frame From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal.
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   106/134 (79.10%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   70/134 (52.24%) 
Blood and lymphatic system disorders   
ANAEMIA  1  2/134 (1.49%) 
FEBRILE NEUTROPENIA  1  7/134 (5.22%) 
LEUKOCYTOSIS  1  1/134 (0.75%) 
LYMPH NODE PAIN  1  1/134 (0.75%) 
LYMPHOCYTOSIS  1  1/134 (0.75%) 
NEUTROPENIA  1  1/134 (0.75%) 
THROMBOCYTOPENIA  1  2/134 (1.49%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  1/134 (0.75%) 
BRADYCARDIA  1  1/134 (0.75%) 
CARDIAC FAILURE CONGESTIVE  1  2/134 (1.49%) 
SUPRAVENTRICULAR TACHYCARDIA  1  2/134 (1.49%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  4/134 (2.99%) 
ASCITES  1  1/134 (0.75%) 
CONSTIPATION  1  1/134 (0.75%) 
DIARRHOEA  1  2/134 (1.49%) 
ENTERITIS  1  1/134 (0.75%) 
FAECES DISCOLOURED  1  1/134 (0.75%) 
GASTRIC HAEMORRHAGE  1  1/134 (0.75%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/134 (0.75%) 
INTESTINAL ISCHAEMIA  1  1/134 (0.75%) 
INTRA-ABDOMINAL HAEMORRHAGE  1  1/134 (0.75%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  1/134 (0.75%) 
NAUSEA  1  2/134 (1.49%) 
PANCREATITIS  1  1/134 (0.75%) 
VOMITING  1  2/134 (1.49%) 
General disorders   
ASTHENIA  1  3/134 (2.24%) 
DEATH  1  1/134 (0.75%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  3/134 (2.24%) 
MUCOSAL INFLAMMATION  1  1/134 (0.75%) 
NON-CARDIAC CHEST PAIN  1  1/134 (0.75%) 
PYREXIA  1  6/134 (4.48%) 
SUDDEN DEATH  1  1/134 (0.75%) 
Hepatobiliary disorders   
CHOLECYSTITIS  1  1/134 (0.75%) 
Infections and infestations   
ATYPICAL PNEUMONIA  1  1/134 (0.75%) 
BACTERAEMIA  1  2/134 (1.49%) 
BACTERIAL SEPSIS  1  1/134 (0.75%) 
BRONCHITIS  1  1/134 (0.75%) 
BRONCHOPNEUMONIA  1  1/134 (0.75%) 
BRONCHOPULMONARY ASPERGILLOSIS  1  2/134 (1.49%) 
CELLULITIS  1  3/134 (2.24%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  2/134 (1.49%) 
ENTEROCOCCAL SEPSIS  1  1/134 (0.75%) 
ENTEROCOLITIS INFECTIOUS  1  1/134 (0.75%) 
H1N1 INFLUENZA  1  1/134 (0.75%) 
INFLUENZA  1  1/134 (0.75%) 
LOBAR PNEUMONIA  1  1/134 (0.75%) 
PNEUMONIA  1  8/134 (5.97%) 
PNEUMONIA BACTERIAL  1  4/134 (2.99%) 
PNEUMONIA KLEBSIELLA  1  1/134 (0.75%) 
PNEUMONIA STREPTOCOCCAL  1  2/134 (1.49%) 
PSEUDOMONAL SEPSIS  1  1/134 (0.75%) 
RESPIRATORY TRACT INFECTION  1  1/134 (0.75%) 
SEPSIS  1  3/134 (2.24%) 
SEPTIC SHOCK  1  1/134 (0.75%) 
STAPHYLOCOCCAL SEPSIS  1  2/134 (1.49%) 
STREPTOCOCCAL BACTERAEMIA  1  1/134 (0.75%) 
URINARY TRACT INFECTION  1  3/134 (2.24%) 
UROSEPSIS  1  1/134 (0.75%) 
Injury, poisoning and procedural complications   
ANKLE FRACTURE  1  2/134 (1.49%) 
FALL  1  1/134 (0.75%) 
SUBDURAL HAEMATOMA  1  1/134 (0.75%) 
Investigations   
CREATININE RENAL CLEARANCE DECREASED  1  1/134 (0.75%) 
Metabolism and nutrition disorders   
DEHYDRATION  1  4/134 (2.99%) 
FAILURE TO THRIVE  1  1/134 (0.75%) 
GOUT  1  1/134 (0.75%) 
HYPERCALCAEMIA  1  1/134 (0.75%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  1/134 (0.75%) 
MUSCULAR WEAKNESS  1  3/134 (2.24%) 
NECK PAIN  1  1/134 (0.75%) 
PAIN IN EXTREMITY  1  1/134 (0.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA  1  3/134 (2.24%) 
MANTLE CELL LYMPHOMA  1  6/134 (4.48%) 
MENINGIOMA  1  1/134 (0.75%) 
METASTATIC SQUAMOUS CELL CARCINOMA  1  1/134 (0.75%) 
MYELODYSPLASTIC SYNDROME  1  1/134 (0.75%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  6/134 (4.48%) 
Nervous system disorders   
HEADACHE  1  1/134 (0.75%) 
MIGRAINE  1  1/134 (0.75%) 
TRANSIENT GLOBAL AMNESIA  1  1/134 (0.75%) 
Renal and urinary disorders   
BLADDER NECK OBSTRUCTION  1  1/134 (0.75%) 
HAEMATURIA  1  1/134 (0.75%) 
RENAL FAILURE  1  2/134 (1.49%) 
URINARY RETENTION  1  1/134 (0.75%) 
Respiratory, thoracic and mediastinal disorders   
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  3/134 (2.24%) 
DYSPNOEA  1  4/134 (2.99%) 
OBSTRUCTIVE AIRWAYS DISORDER  1  1/134 (0.75%) 
PLEURAL EFFUSION  1  2/134 (1.49%) 
PNEUMONITIS  1  1/134 (0.75%) 
PULMONARY EMBOLISM  1  1/134 (0.75%) 
RESPIRATORY DISTRESS  1  2/134 (1.49%) 
RESPIRATORY FAILURE  1  1/134 (0.75%) 
Skin and subcutaneous tissue disorders   
SKIN TOXICITY  1  1/134 (0.75%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  2/134 (1.49%) 
HYPOTENSION  1  7/134 (5.22%) 
ORTHOSTATIC HYPOTENSION  1  1/134 (0.75%) 
1
Term from vocabulary, 17.0
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Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide
Affected / at Risk (%)
Total   125/134 (93.28%) 
Blood and lymphatic system disorders   
ANAEMIA  1  42/134 (31.34%) 
LEUKOPENIA  1  22/134 (16.42%) 
LYMPHOPENIA  1  10/134 (7.46%) 
NEUTROPENIA  1  68/134 (50.75%) 
THROMBOCYTOPENIA  1  51/134 (38.06%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  10/134 (7.46%) 
CONSTIPATION  1  21/134 (15.67%) 
DIARRHOEA  1  45/134 (33.58%) 
NAUSEA  1  41/134 (30.60%) 
VOMITING  1  16/134 (11.94%) 
General disorders   
ASTHENIA  1  18/134 (13.43%) 
CHILLS  1  8/134 (5.97%) 
FATIGUE  1  47/134 (35.07%) 
OEDEMA PERIPHERAL  1  22/134 (16.42%) 
PYREXIA  1  30/134 (22.39%) 
Infections and infestations   
NASOPHARYNGITIS  1  8/134 (5.97%) 
PNEUMONIA  1  8/134 (5.97%) 
RESPIRATORY TRACT INFECTION  1  9/134 (6.72%) 
SINUSITIS  1  9/134 (6.72%) 
UPPER RESPIRATORY TRACT INFECTION  1  20/134 (14.93%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  7/134 (5.22%) 
BLOOD CREATININE INCREASED  1  7/134 (5.22%) 
WEIGHT DECREASED  1  20/134 (14.93%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  21/134 (15.67%) 
DEHYDRATION  1  8/134 (5.97%) 
HYPOCALCAEMIA  1  7/134 (5.22%) 
HYPOKALAEMIA  1  19/134 (14.18%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  12/134 (8.96%) 
BACK PAIN  1  19/134 (14.18%) 
MUSCLE SPASMS  1  17/134 (12.69%) 
PAIN IN EXTREMITY  1  9/134 (6.72%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
TUMOUR FLARE  1  13/134 (9.70%) 
Nervous system disorders   
DIZZINESS  1  7/134 (5.22%) 
DYSGEUSIA  1  8/134 (5.97%) 
HEADACHE  1  8/134 (5.97%) 
NEUROPATHY PERIPHERAL  1  9/134 (6.72%) 
Psychiatric disorders   
ANXIETY  1  11/134 (8.21%) 
INSOMNIA  1  8/134 (5.97%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  41/134 (30.60%) 
DYSPHONIA  1  9/134 (6.72%) 
DYSPNOEA  1  24/134 (17.91%) 
OROPHARYNGEAL PAIN  1  14/134 (10.45%) 
PLEURAL EFFUSION  1  8/134 (5.97%) 
Skin and subcutaneous tissue disorders   
DRY SKIN  1  10/134 (7.46%) 
NIGHT SWEATS  1  8/134 (5.97%) 
PRURITUS  1  23/134 (17.16%) 
RASH  1  30/134 (22.39%) 
1
Term from vocabulary, 17.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Single center publications may not be submitted until after multicenter publication is submitted (or 1 year after study completion), whichever comes first. The investigator may then publish results provided that Celgene receive a copy of any proposed publication/presentation at least 30 days in advance of submission, delete any confidential information & delay the submission for up to 60 additional days for patent filing. Multicenter publications must include input from investigators & Celgene.
Results Point of Contact
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Name/Title: Senior Manager, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialsdisclosure@celgene.com
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00737529     History of Changes
Other Study ID Numbers: CC-5013-MCL-001
First Submitted: August 15, 2008
First Posted: August 19, 2008
Results First Submitted: June 28, 2013
Results First Posted: September 9, 2013
Last Update Posted: December 13, 2018