Trial Outcomes & Findings for Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality (NCT NCT00065156)
NCT ID: NCT00065156
Last Updated: 2019-11-19
Results Overview
Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
148 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
Lenalidomide
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
Modified Intent to Treat Population
|
94
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
124
|
Reasons for withdrawal
| Measure |
Lenalidomide
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Lack of Efficacy
|
52
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
11
|
|
Overall Study
Study Closed by Sponsor
|
2
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Investigator Decision
|
2
|
|
Overall Study
Non-Compliance
|
2
|
|
Overall Study
Loss of Response
|
1
|
|
Overall Study
Secondary Malign Disease
|
1
|
Baseline Characteristics
Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=148 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Age, Customized
<= 65 years
|
48 participants
n=5 Participants
|
|
Age, Customized
>65 years
|
100 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
143 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=5 Participants
|
|
Duration of Myelodysplastic Syndrome (MDS)
|
3.4 years
STANDARD_DEVIATION 3.29 • n=5 Participants
|
|
Participants with 5q(-) (31-33) Chromosomal Abnormality
|
148 participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Score
Low (0)
|
49 participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Score
Intermediate-1 (0.5 to 1.0)
|
69 participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Score
Intermediate-2 (1.5 to 2.0)
|
7 participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Score
High (>=2.5)
|
2 participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Score
Missing (unable to assign)
|
21 participants
n=5 Participants
|
|
French-American-British (FAB) Classification
Refractory anemia (RA)
|
78 participants
n=5 Participants
|
|
French-American-British (FAB) Classification
Refractory anemia with ringed sideroblasts (RARS)
|
16 participants
n=5 Participants
|
|
French-American-British (FAB) Classification
Refractory anemia with excess blasts (RAEB)
|
30 participants
n=5 Participants
|
|
French-American-British (FAB) Classification
Chronic myelomonocytic leukemia (CMML)
|
3 participants
n=5 Participants
|
|
French-American-British (FAB) Classification
Acute leukemia
|
1 participants
n=5 Participants
|
|
French-American-British (FAB) Classification
Unable to classify
|
20 participants
n=5 Participants
|
|
Cytogenetic Complexity
Isolated 5q
|
110 participants
n=5 Participants
|
|
Cytogenetic Complexity
Intermediate (5q + 1 abnormality)
|
25 participants
n=5 Participants
|
|
Cytogenetic Complexity
Complex
|
12 participants
n=5 Participants
|
|
Cytogenetic Complexity
Unknown
|
1 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
59 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
75 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 - 5
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Modified Intent to Treat (MITT) * diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation * received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period * received ≥1 dose of study drug
Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.
Outcome measures
| Measure |
Lenalidomide
n=94 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence
|
59 participants
|
SECONDARY outcome
Timeframe: Up to 2 YearsPopulation: Safety population included all participants who received at least one dose of study drug.
Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.
Outcome measures
| Measure |
Lenalidomide
n=148 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participants With Adverse Experiences
At least one AE
|
148 participants
|
|
Participants With Adverse Experiences
At least one AE related to study drug
|
143 participants
|
|
Participants With Adverse Experiences
At least one NCI CTC grade 3-4 AE
|
140 participants
|
|
Participants With Adverse Experiences
At least one NCI CTC grade 3-4 AE related to drug
|
131 participants
|
|
Participants With Adverse Experiences
At least one serious AE
|
89 participants
|
|
Participants With Adverse Experiences
At least one serious AE related to study drug
|
40 participants
|
|
Participants With Adverse Experiences
AE leading to dose reduction or interruption
|
131 participants
|
|
Participants With Adverse Experiences
AE leading to discontinuation of study drug
|
47 participants
|
SECONDARY outcome
Timeframe: Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)Population: Modified Intent to Treat (MITT) * diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation * received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period * received ≥1 dose of study drug
A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment).
Outcome measures
| Measure |
Lenalidomide
n=94 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study
|
70 participant
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Modified intent to treat population who achieved transfusion independence
Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period.
Outcome measures
| Measure |
Lenalidomide
n=59 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Time to Transfusion Independence
|
6.2 weeks
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Modified intent to treat population who achieved transfusion independence
Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study.
Outcome measures
| Measure |
Lenalidomide
n=59 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study
Relapsed (had a transfusion after response)
|
35 participants
|
|
Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study
Maintained transfusion independence
|
24 participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Modified intent to treat population who achieved transfusion independence
Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence.
Outcome measures
| Measure |
Lenalidomide
n=59 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Kaplan Meier Estimate for Duration of Transfusion Independence Response
|
97.0 weeks
Interval 52.9 to 191.9
|
SECONDARY outcome
Timeframe: Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)Population: Modified intent to treat population who achieved transfusion independence
The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline.
Outcome measures
| Measure |
Lenalidomide
n=59 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders
|
6.1 g/dL
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits.
Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline.
Outcome measures
| Measure |
Lenalidomide
n=52 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participant Counts of Cytogenetic Response
Major
|
18 participants
|
|
Participant Counts of Cytogenetic Response
Minor
|
20 participants
|
|
Participant Counts of Cytogenetic Response
None
|
14 participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count \<100 \* 10\^9/L to be included in the analysis.
Major platelet response: participants with a minimum pretreatment platelet of \<100,000/mm\^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm\^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence. Minor platelet response: participants with a minimum pretreatment platelet of \<100,000/mm\^3, a ≥ 50% increase in platelet count with a net increase \>10,000/mm\^3 for a consecutive 56-day period in the absence of platelet transfusions.
Outcome measures
| Measure |
Lenalidomide
n=15 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participant Counts of Platelet Response
Major
|
2 participants
|
|
Participant Counts of Platelet Response
Minor
|
0 participants
|
|
Participant Counts of Platelet Response
None
|
13 participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) \<1 \* 10\^9/L.
Major neutrophil response: participants with a minimum pretreatment ANC concentration of \< 1500/mm\^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of ≥ 500/mm\^3, whichever was greater (at least to be ≥ 500/mm\^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of \< 1500/mm\^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days.
Outcome measures
| Measure |
Lenalidomide
n=27 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participant Counts of Absolute Neutrophil Count (ANC) Response
Major
|
9 participant
|
|
Participant Counts of Absolute Neutrophil Count (ANC) Response
Minor
|
0 participant
|
|
Participant Counts of Absolute Neutrophil Count (ANC) Response
None
|
18 participant
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.
Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist.
Outcome measures
| Measure |
Lenalidomide
n=94 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participants With Complete or Partial Bone Marrow Improvement
Complete bone marrow improvement
|
22 participants
|
|
Participants With Complete or Partial Bone Marrow Improvement
Partial bone marrow improvement
|
15 participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.
Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics): * Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB). * Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML).
Outcome measures
| Measure |
Lenalidomide
n=94 Participants
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Participants With Bone Marrow Progression
RA/RARS to RAEB
|
11 participants
|
|
Participants With Bone Marrow Progression
RA/RARS/RAEB/CMML to AML
|
6 participants
|
Adverse Events
Lenalidomide
Serious events: 89 serious events
Other events: 148 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide
n=148 participants at risk
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Infections and infestations
Pneumonia Not Otherwise Specified (NOS)
|
10.1%
15/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.8%
10/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
5.4%
8/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
8/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.4%
8/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Leukaemia NOS
|
4.7%
7/148 • Up to 2 years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.1%
6/148 • Up to 2 years
|
|
Infections and infestations
Sepsis NOS
|
4.1%
6/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.1%
6/148 • Up to 2 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.4%
5/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.4%
5/148 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting NOS
|
3.4%
5/148 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
2.7%
4/148 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
2.7%
4/148 • Up to 2 years
|
|
General disorders
Pyrexia
|
2.7%
4/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia NOS
|
2.0%
3/148 • Up to 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
3/148 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
2.0%
3/148 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroenteritis NOS
|
2.0%
3/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
2.0%
3/148 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
3/148 • Up to 2 years
|
|
General disorders
Asthenia
|
1.4%
2/148 • Up to 2 years
|
|
Infections and infestations
Bacteraemia
|
1.4%
2/148 • Up to 2 years
|
|
Cardiac disorders
Cardiac Failure NOS
|
1.4%
2/148 • Up to 2 years
|
|
Infections and infestations
Cellulitis
|
1.4%
2/148 • Up to 2 years
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.4%
2/148 • Up to 2 years
|
|
Nervous system disorders
Depressed Level of Consciousness
|
1.4%
2/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
1.4%
2/148 • Up to 2 years
|
|
General disorders
Fall
|
1.4%
2/148 • Up to 2 years
|
|
General disorders
Fatigue
|
1.4%
2/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.4%
2/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.4%
2/148 • Up to 2 years
|
|
Infections and infestations
Infection NOS
|
1.4%
2/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Medical Device Complication
|
1.4%
2/148 • Up to 2 years
|
|
General disorders
Multi-Organ Failure
|
1.4%
2/148 • Up to 2 years
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
2/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.4%
2/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
1.4%
2/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension NOS
|
1.4%
2/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
1.4%
2/148 • Up to 2 years
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.4%
2/148 • Up to 2 years
|
|
Renal and urinary disorders
Renal Failure NOS
|
1.4%
2/148 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
1.4%
2/148 • Up to 2 years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.4%
2/148 • Up to 2 years
|
|
Infections and infestations
Urinary Tract Infection NOS
|
1.4%
2/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Acute Febrile Neutrophilic Dermatosis
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Aphasia
|
0.68%
1/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthrlagia
|
0.68%
1/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma NOS
|
0.68%
1/148 • Up to 2 years
|
|
Renal and urinary disorders
Azotaemia
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma NOS
|
0.68%
1/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.68%
1/148 • Up to 2 years
|
|
Investigations
Blood Creatinine Increased
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Bronchitis Acute NOS
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour of the Small Bowel
|
0.68%
1/148 • Up to 2 years
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.68%
1/148 • Up to 2 years
|
|
Cardiac disorders
Cardiomyopathy NOS
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Central Line Infection
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.68%
1/148 • Up to 2 years
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.68%
1/148 • Up to 2 years
|
|
General disorders
Chest Pain
|
0.68%
1/148 • Up to 2 years
|
|
Hepatobiliary disorders
Cholecystitis NOS
|
0.68%
1/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Clostridial Infection NOS
|
0.68%
1/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.68%
1/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Comminuted Fracture
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Convulsions NOS
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Dementia NOS
|
0.68%
1/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis Medicamentosa
|
0.68%
1/148 • Up to 2 years
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Enterobacter Sepsis
|
0.68%
1/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Gastritis NOS
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Groin Infection
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Headache
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Herpes Zoster
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.68%
1/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.68%
1/148 • Up to 2 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.68%
1/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.68%
1/148 • Up to 2 years
|
|
Immune system disorders
Hypersensitivity NOS
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.68%
1/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia NOS
|
0.68%
1/148 • Up to 2 years
|
|
Vascular disorders
Hypotension NOS
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Influenza
|
0.68%
1/148 • Up to 2 years
|
|
General disorders
Intermittent Pyrexia
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Intestinal Perforation NOS
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Klebsiella Sepsis
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Lobar Pneumonia NOS
|
0.68%
1/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Localised Osteoarthritis
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.68%
1/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration NOS
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Migraine NOS
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Oesophageal Perforation
|
0.68%
1/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer NOS
|
0.68%
1/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Overdose NOS
|
0.68%
1/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.68%
1/148 • Up to 2 years
|
|
Vascular disorders
Peripheral Ischaemia
|
0.68%
1/148 • Up to 2 years
|
|
Gastrointestinal disorders
Perirectal Abscess
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Post Procedural Site Wound Infection
|
0.68%
1/148 • Up to 2 years
|
|
Cardiac disorders
Pulmonary Oedema NOS
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory Anaemia with Excess Blasts in Transformation
|
0.68%
1/148 • Up to 2 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.68%
1/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.68%
1/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.68%
1/148 • Up to 2 years
|
|
General disorders
Rigors
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Senile Dementia NOS
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Sinusitis Acute NOS
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Sinusitis NOS
|
0.68%
1/148 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Subarachnoid Haemorrhage NOS
|
0.68%
1/148 • Up to 2 years
|
|
Nervous system disorders
Subdural Haematoma
|
0.68%
1/148 • Up to 2 years
|
|
General disorders
Sudden Death
|
0.68%
1/148 • Up to 2 years
|
|
Cardiac disorders
Tachyarrhythmia
|
0.68%
1/148 • Up to 2 years
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.68%
1/148 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma NOS
|
0.68%
1/148 • Up to 2 years
|
|
Investigations
Troponin I Increased
|
0.68%
1/148 • Up to 2 years
|
|
Infections and infestations
Vaginosis Fungal NOS
|
0.68%
1/148 • Up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.68%
1/148 • Up to 2 years
|
Other adverse events
| Measure |
Lenalidomide
n=148 participants at risk
The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
62.8%
93/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
61.5%
91/148 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhoea Not Otherwise Specified (NOS)
|
58.8%
87/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.6%
66/148 • Up to 2 years
|
|
General disorders
Fatigue
|
41.9%
62/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
36.5%
54/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.1%
46/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
29.7%
44/148 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
27.7%
41/148 • Up to 2 years
|
|
General disorders
Oedema Peripheral
|
27.0%
40/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
26.4%
39/148 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
26.4%
39/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.7%
38/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
25.0%
37/148 • Up to 2 years
|
|
General disorders
Pyrexia
|
25.0%
37/148 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
23.6%
35/148 • Up to 2 years
|
|
Nervous system disorders
Headache
|
22.3%
33/148 • Up to 2 years
|
|
Infections and infestations
Upper Respiratory Tract Infection NOS
|
22.3%
33/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
21.6%
32/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
20.9%
31/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
19.6%
29/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Limb
|
16.9%
25/148 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
16.2%
24/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.2%
24/148 • Up to 2 years
|
|
General disorders
Asthenia
|
14.9%
22/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.9%
22/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.2%
21/148 • Up to 2 years
|
|
Infections and infestations
Urinary Tract Infection NOS
|
14.2%
21/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
13.5%
20/148 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
12.8%
19/148 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
12.8%
19/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.8%
19/148 • Up to 2 years
|
|
Infections and infestations
Sinusitis NOS
|
12.8%
19/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Contusion
|
12.2%
18/148 • Up to 2 years
|
|
General disorders
Oedema NOS
|
12.2%
18/148 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting NOS
|
12.2%
18/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis NOS
|
11.5%
17/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.8%
16/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
10.8%
16/148 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.5%
14/148 • Up to 2 years
|
|
Endocrine disorders
Acquired Hypothyroidism
|
9.5%
14/148 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
9.5%
14/148 • Up to 2 years
|
|
General disorders
Pain NOS
|
9.5%
14/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Peripheral Swelling
|
9.5%
14/148 • Up to 2 years
|
|
General disorders
Fall
|
8.8%
13/148 • Up to 2 years
|
|
Vascular disorders
Hypertension NOS
|
8.8%
13/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Sweating Increased
|
8.8%
13/148 • Up to 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
8.1%
12/148 • Up to 2 years
|
|
Infections and infestations
Cellulitis
|
8.1%
12/148 • Up to 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
8.1%
12/148 • Up to 2 years
|
|
Renal and urinary disorders
Dysuria
|
8.1%
12/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.1%
12/148 • Up to 2 years
|
|
Gastrointestinal disorders
Loose Stools
|
8.1%
12/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis NOS
|
8.1%
12/148 • Up to 2 years
|
|
Investigations
Weight Decreased
|
8.1%
12/148 • Up to 2 years
|
|
General disorders
Chest Pain
|
7.4%
11/148 • Up to 2 years
|
|
Nervous system disorders
Hypoaesthesia
|
7.4%
11/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.4%
11/148 • Up to 2 years
|
|
Infections and infestations
Influenza
|
7.4%
11/148 • Up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
7.4%
11/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
10/148 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
6.8%
10/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.8%
10/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Foot
|
6.8%
10/148 • Up to 2 years
|
|
Cardiac disorders
Palpitations
|
6.8%
10/148 • Up to 2 years
|
|
Nervous system disorders
Paraesthesia
|
6.8%
10/148 • Up to 2 years
|
|
Nervous system disorders
Peripheral Neuropathy NOS
|
6.8%
10/148 • Up to 2 years
|
|
Eye disorders
Conjunctivitis
|
6.1%
9/148 • Up to 2 years
|
|
General disorders
Rigors
|
6.1%
9/148 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
5.4%
8/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Appetite Decreased NOS
|
5.4%
8/148 • Up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
8/148 • Up to 2 years
|
|
Infections and infestations
Herpes Simplex
|
5.4%
8/148 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
8/148 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.4%
8/148 • Up to 2 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
5.4%
8/148 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.4%
8/148 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Lesions NOS
|
5.4%
8/148 • Up to 2 years
|
|
Eye disorders
Vision Blurred
|
5.4%
8/148 • Up to 2 years
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Unless approved by Celgene, single center data will not be published before multicenter data, unless more than 1 year has elapsed since completion of the Study. Thereafter, Investigator may publish single center data provided that Investigator shall: i) provide a copy of the publication to Celgene at least 60 days in advance of submission for publication; ii) delete Celgene Confidential Information and; iii) delay submission up to 90 additional days to permit intellectual property filings.
- Publication restrictions are in place
Restriction type: OTHER