Trial Outcomes & Findings for A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma (NCT NCT01724177)
NCT ID: NCT01724177
Last Updated: 2018-05-29
Results Overview
ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
Results posted on
2018-05-29
Participant Flow
This study included Japanese participants with relapsed or recurrent adult T-cell leukemia (ATL) who had previously received anti- ATL chemotherapy and who were categorized as having acute-lymphoma or unfavorable chronic-type ATL.
Participant milestones
| Measure |
Lenalidomide
Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Safety Population
|
26
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Lenalidomide
Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Progressive disease or Relapsed Disease
|
16
|
|
Overall Study
Nervous participant
|
1
|
|
Overall Study
Serious Adverse Event Related
|
1
|
Baseline Characteristics
Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = Fully Active
|
13 Participants
n=5 Participants • Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = Restrictive but Ambulatory
|
9 Participants
n=5 Participants • Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = Ambulatory but Unable to Work
|
4 Participants
n=5 Participants • Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 = Limited Self-Care
|
0 Participants
n=5 Participants • Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
|
PRIMARY outcome
Timeframe: From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeksPopulation: The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
Outcome measures
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
|
42.3 percentage of participants
Interval 23.352 to 63.082
|
SECONDARY outcome
Timeframe: From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeksPopulation: The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
Outcome measures
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
|
16.30 weeks
Interval 8.1 to 24.0
|
SECONDARY outcome
Timeframe: From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeksPopulation: The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC
Outcome measures
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Kaplan-Meier Estimate of Time to Progression (TTP)
|
16.30 weeks
Interval 8.1 to 24.0
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeksPopulation: Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.
Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were 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.
Outcome measures
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 TEAE Related to Lenalidomide
|
26 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 NCI CTCAE Grade (GR) 3 or Greater TEAE
|
25 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 NCI CTCAE ≥ GR 3 TEAE Related to Lenalidomide
|
25 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 Serious TEAE
|
11 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 Serious TEAE Related to Lenalidomide
|
9 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 TEAE Leading to Discontinuation
|
8 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 Related TEAE Leading to Discontinuation
|
8 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 TEAE Leading to Dose Reduction/Interruption
|
17 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 related TEAE Leading to Decrease/Interruption
|
17 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 TEAE Resulting in Death
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
≥ 1 TEAE
|
26 participants
|
SECONDARY outcome
Timeframe: From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 WeeksPopulation: The EE population who had a documented response and consisted of participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
Outcome measures
| Measure |
Lenalidomide
n=11 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC
|
24.10 weeks
Interval 2.0 to
Only one event data observed exceeding the median value, and maximum value was censored data, so the upper bound of confidence interval (CI) could not be estimated
|
SECONDARY outcome
Timeframe: From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeksPopulation: The EE population with a response (CR, CRu, PR or SD) and consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.
Outcome measures
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
|
73.1 percentage of participants
Interval 52.213 to 88.427
|
SECONDARY outcome
Timeframe: From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeksPopulation: The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.
Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.
Outcome measures
| Measure |
Lenalidomide
n=26 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Kaplan-Meier Estimate for Overall Survival
|
88.10 weeks
Interval 43.0 to 109.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeksPopulation: Participants with a response of PR or better.
Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)
Outcome measures
| Measure |
Lenalidomide
n=11 Participants
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Time to Response
|
8.10 weeks
Interval 7.9 to 16.0
|
Adverse Events
Lenalidomide
Serious events: 11 serious events
Other events: 26 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Lenalidomide
n=26 participants at risk
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
General disorders
Non-cardiac chest pain
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
General disorders
Pyrexia
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Enterocolitis infectious
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Meningitis bacterial
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Cardiac disorders
Acute left ventricular failure
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Hepatobiliary disorders
Acute hepatic failure
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood pressure decreased
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Sinusitis fungal
|
3.8%
1/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
Other adverse events
| Measure |
Lenalidomide
n=26 participants at risk
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
C-reactive protein increased
|
42.3%
11/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Alanine aminotransferase increased
|
30.8%
8/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
26.9%
7/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
19.2%
5/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood urea increased
|
19.2%
5/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood creatinine increased
|
15.4%
4/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Differential white blood cell count abnormal
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Glucose urine present
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood urine present
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Neutrophil count decreased
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Weight decreased
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
6/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.2%
5/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
34.6%
9/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
34.6%
9/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.1%
6/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
15.4%
4/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
76.9%
20/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
73.1%
19/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
69.2%
18/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
57.7%
15/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
13/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
19.2%
5/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Basophilia
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
34.6%
9/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
34.6%
9/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
30.8%
8/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Gastrointestinal disorders
Nausea
|
26.9%
7/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
6/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
15.4%
4/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
General disorders
Malaise
|
19.2%
5/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
General disorders
Fatigue
|
15.4%
4/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
General disorders
Pyrexia
|
15.4%
4/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
General disorders
Oedema peripheral
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Cardiac disorders
Bradycardia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Cardiac disorders
Supraventricular extrasystoles
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
23.1%
6/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
19.2%
5/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Vascular disorders
Phlebitis
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Psychiatric disorders
Insomnia
|
11.5%
3/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Immune system disorders
Hypogammaglobulinaemia
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Eosinophil count increased
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Basophil count increased
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Investigations
Blood albumin decreased
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
7.7%
2/26 • From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.
- Publication restrictions are in place
Restriction type: OTHER