Trial Outcomes & Findings for 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 (NCT NCT00737529)
NCT ID: NCT00737529
Last Updated: 2018-12-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
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.
Results posted on
2018-12-13
Participant Flow
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.
All participants were required to have local histologic confirmation of Mantle Cell Lymphoma (MCL) for entry into the study.
Participant milestones
| Measure |
Lenalidomide
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 Study
STARTED
|
134
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
133
|
Reasons for withdrawal
| Measure |
Lenalidomide
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 Study
Disease Progression
|
95
|
|
Overall Study
Adverse Event
|
24
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 8.38 • n=93 Participants
|
|
Age, Customized
<65
|
49 Participants
n=93 Participants
|
|
Age, Customized
≥ 65
|
85 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
128 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = (Fully Active)
|
43 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = (Restrictive but ambulatory)
|
73 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = (Ambulatory but unable to work)
|
17 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 = (Limited self care)
|
1 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4 = (Completely Disabled)
|
0 Participants
n=93 Participants
|
|
Renal function at baseline
Normal (CrCl > = 60 mL/min)
|
99 Participants
n=93 Participants
|
|
Renal function at baseline
Moderate Renal Insufficiency (CrCl ≥ 30 and < 60mL
|
28 Participants
n=93 Participants
|
|
Renal function at baseline
Severe Renal Insufficiency (CrCl < 30 mL/min)
|
1 Participants
n=93 Participants
|
|
Renal function at baseline
Missing
|
6 Participants
n=93 Participants
|
|
Duration of Mantle Cell Lymphoma
<3 years
|
52 years
n=93 Participants
|
|
Duration of Mantle Cell Lymphoma
≥ 3 years
|
82 years
n=93 Participants
|
|
MCL (Ann Arbor) Stage at Diagnosis
I
|
2 Participants
n=93 Participants
|
|
MCL (Ann Arbor) Stage at Diagnosis
II
|
5 Participants
n=93 Participants
|
|
MCL (Ann Arbor) Stage at Diagnosis
III
|
19 Participants
n=93 Participants
|
|
MCL (Ann Arbor) Stage at Diagnosis
IV
|
105 Participants
n=93 Participants
|
|
MCL (Ann Arbor) Stage at Diagnosis
Missing
|
3 Participants
n=93 Participants
|
|
MCL International Prognostic Index (MIPI) Score Group at Enrollment
Low
|
39 Participants
n=93 Participants
|
|
MCL International Prognostic Index (MIPI) Score Group at Enrollment
Intermediate
|
51 Participants
n=93 Participants
|
|
MCL International Prognostic Index (MIPI) Score Group at Enrollment
High
|
39 Participants
n=93 Participants
|
|
MCL International Prognostic Index (MIPI) Score Group at Enrollment
Missing
|
5 Participants
n=93 Participants
|
|
Prior Bone Marrow Assessment
Positive
|
55 Participants
n=93 Participants
|
|
Prior Bone Marrow Assessment
Negative
|
52 Participants
n=93 Participants
|
|
Prior Bone Marrow Assessment
Indeterminate
|
8 Participants
n=93 Participants
|
|
Prior Bone Marrow Assessment
Missing
|
19 Participants
n=93 Participants
|
|
Tumor Burden
High = having 1 lesion ≥ 5 cm or 3 lesions ≥ 3cm
|
78 Participants
n=93 Participants
|
|
Tumor Burden
Low = < 5cm lesions
|
54 Participants
n=93 Participants
|
|
Tumor Burden
Missing = unable to characterize
|
2 Participants
n=93 Participants
|
|
Bulky Disease
Yes
|
44 Participants
n=93 Participants
|
|
Bulky Disease
No
|
88 Participants
n=93 Participants
|
|
Bulky Disease
Missing
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.Population: ITT population defined as all enrolled participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)
|
29.9 percentage of participants
Interval 22.26 to 38.36
|
PRIMARY outcome
Timeframe: 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.Population: Includes participants from the ITT population who achieved a PR or better.
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.
Outcome measures
| Measure |
Lenalidomide
n=40 Participants
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.
|
|---|---|
|
Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee
|
16.64 months
Interval 10.4219 to 29.8191
|
SECONDARY outcome
Timeframe: 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 daysPopulation: The ITT population was defined as all enrolled participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee
|
9.0 percentage of participants
Interval 4.71 to 15.12
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Includes participants from the ITT population who achieved a CRu or better.
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.
Outcome measures
| Measure |
Lenalidomide
n=12 Participants
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.
|
|---|---|
|
Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee
|
24.43 months
Interval 5.063 to
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.
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee
|
4.01 months
Interval 3.6822 to 7.2329
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.
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
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee
|
5.46 months
Interval 3.7479 to 9.4685
|
SECONDARY outcome
Timeframe: 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 daysPopulation: Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee
|
3.75 months
Interval 2.3342 to 4.6356
|
SECONDARY outcome
Timeframe: 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 daysPopulation: Included participants from the ITT population who achieved a PR or better.
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.
Outcome measures
| Measure |
Lenalidomide
n=40 Participants
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.
|
|---|---|
|
Time to Response (TTR)
|
3.5 months
Interval 1.7 to 15.9
|
SECONDARY outcome
Timeframe: 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 daysPopulation: Included participants from the ITT population who achieved a CRu or better.
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.
Outcome measures
| Measure |
Lenalidomide
n=12 Participants
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.
|
|---|---|
|
Time to Complete Response (CR+CRu) According to the Independent Review Committee
|
3.9 months
Interval 1.9 to 13.0
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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 Survival (OS)
|
19.50 months
Interval 13.6767 to 25.5781
|
SECONDARY outcome
Timeframe: 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)Population: The safety population received at least one dose of lenalidomide was used for all safety analysis. This was identical to the ITT population.
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.
Outcome measures
| Measure |
Lenalidomide
n=134 Participants
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.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
132 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Related to Investigational Product (IP)
|
118 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Grade 3-5 AE
|
106 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Grade 3 AE
|
101 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Grade 4 AE
|
57 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Grade 5 AE
|
18 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 3-5 AE Related to IP
|
90 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 3 AE Related to IP
|
88 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 4 AE Related to IP
|
41 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 5 AE Related to IP
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Serious Adverse Event (SAE)
|
70 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any SAE Related to IP
|
30 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Leading to Stopping of IP
|
28 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Treatment Related AE Leading to Stopping IP
|
16 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any AE Leading to Dose Reduction
|
55 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any AE Leading to IP Interruption
|
81 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Treatment Related AE Leading to Dose Reduction
|
52 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment Related AE Leading to IP Interruption
|
66 participants
|
Adverse Events
Lenalidomide
Serious events: 70 serious events
Other events: 125 other events
Deaths: 106 deaths
Serious adverse events
| Measure |
Lenalidomide
n=134 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
5.2%
7/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Cardiac disorders
BRADYCARDIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.0%
4/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
ASCITES
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
ENTERITIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
NAUSEA
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
VOMITING
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
ASTHENIA
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
DEATH
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
PYREXIA
|
4.5%
6/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
SUDDEN DEATH
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
ATYPICAL PNEUMONIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
BACTERAEMIA
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
BRONCHITIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
CELLULITIS
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
H1N1 INFLUENZA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
INFLUENZA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
PNEUMONIA
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
3.0%
4/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
PNEUMONIA KLEBSIELLA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
SEPSIS
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
SEPTIC SHOCK
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
STREPTOCOCCAL BACTERAEMIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
UROSEPSIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Injury, poisoning and procedural complications
FALL
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Investigations
CREATININE RENAL CLEARANCE DECREASED
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.0%
4/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
GOUT
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MANTLE CELL LYMPHOMA
|
4.5%
6/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
4.5%
6/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
HEADACHE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
MIGRAINE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
TRANSIENT GLOBAL AMNESIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Renal and urinary disorders
BLADDER NECK OBSTRUCTION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Renal and urinary disorders
HAEMATURIA
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.2%
3/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.0%
4/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.5%
2/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Vascular disorders
HYPOTENSION
|
5.2%
7/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.75%
1/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
Other adverse events
| Measure |
Lenalidomide
n=134 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
31.3%
42/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
16.4%
22/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
7.5%
10/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
50.7%
68/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
38.1%
51/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
7.5%
10/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.7%
21/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
DIARRHOEA
|
33.6%
45/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
NAUSEA
|
30.6%
41/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Gastrointestinal disorders
VOMITING
|
11.9%
16/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
ASTHENIA
|
13.4%
18/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
CHILLS
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
FATIGUE
|
35.1%
47/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
OEDEMA PERIPHERAL
|
16.4%
22/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
General disorders
PYREXIA
|
22.4%
30/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
PNEUMONIA
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
6.7%
9/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
SINUSITIS
|
6.7%
9/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
14.9%
20/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.2%
7/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Investigations
BLOOD CREATININE INCREASED
|
5.2%
7/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Investigations
WEIGHT DECREASED
|
14.9%
20/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
15.7%
21/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
5.2%
7/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
14.2%
19/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.0%
12/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.2%
19/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
12.7%
17/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
9/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR FLARE
|
9.7%
13/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
DIZZINESS
|
5.2%
7/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
DYSGEUSIA
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
HEADACHE
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
6.7%
9/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Psychiatric disorders
ANXIETY
|
8.2%
11/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Psychiatric disorders
INSOMNIA
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
30.6%
41/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
6.7%
9/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
17.9%
24/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
10.4%
14/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.5%
10/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
6.0%
8/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
17.2%
23/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
|
Skin and subcutaneous tissue disorders
RASH
|
22.4%
30/134 • From the first dose of 1enalidomide through 28 days after the last dose of lenalidomide; (maximum duration of study drug was 1940 days).
|
Additional Information
Senior Manager, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER