Trial Outcomes & Findings for A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02538965)
NCT ID: NCT02538965
Last Updated: 2020-01-07
Results Overview
The morphological complete response rate was defined as the total number of participants with morphological CR observed within the first 4 cycles of lenalidomide (regardless of whether the CR/CRi was observed at the end of Cycle 1, 2, 3 or 4) over the total number of participants evaluable for this endpoint. According to Modified IWG criteria, morphologic CR was defined as: 1. Absolute neutrophil count (ANC) ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (i.e., no transfusion or exogenous growth factor within 7 days of assessment; 2. Bone marrow \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. Morphologic CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
From day of the first dose of IP to end of cycle 4; Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3, and 4 and at treatment discontinuation.
Results posted on
2020-01-07
Participant Flow
Participants were enrolled at 15 centers within the United States and Canada.
The study population consisted of pediatric participants with relapsed or refractory Acute Myeloid Leukemia (rrAML) from 1 to ≤ 18 years of age and were required to have a fresh bone marrow aspirate and biopsy submitted for confirmation of disease.
Participant milestones
| Measure |
Lenalidomide
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Treatment Period
STARTED
|
17
|
|
Treatment Period
COMPLETED
|
0
|
|
Treatment Period
NOT COMPLETED
|
17
|
|
Follow-Up Period
STARTED
|
17
|
|
Follow-Up Period
COMPLETED
|
0
|
|
Follow-Up Period
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Lenalidomide
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Treatment Period
Other = Death due to disease progression
|
1
|
|
Treatment Period
Adverse Event
|
2
|
|
Treatment Period
Withdrawal by Parent/Guardian
|
2
|
|
Treatment Period
Treatment Failure
|
9
|
|
Treatment Period
Disease Progression
|
1
|
|
Treatment Period
Physician Decision
|
2
|
|
Follow-Up Period
Other = Death due to disease progression
|
13
|
|
Follow-Up Period
Withdrawal by Parent
|
4
|
Baseline Characteristics
Includes participants with available data.
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
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|---|---|
|
Age, Continuous
|
11.5 years
STANDARD_DEVIATION 4.56 • n=17 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Not Collected or Reported
|
3 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=17 Participants
|
|
Age Categories
≤ 2 years
|
0 Participants
n=17 Participants
|
|
Age Categories
3-6 years
|
4 Participants
n=17 Participants
|
|
Age Categories
7-12 years
|
6 Participants
n=17 Participants
|
|
Age Categories
13-16 years
|
4 Participants
n=17 Participants
|
|
Age Categories
≥ 17 years
|
3 Participants
n=17 Participants
|
|
Peripheral Blood Smear Blasts
|
8.7 Percent of Blasts
n=15 Participants • Includes participants with available data.
|
|
White Blood Cell Count
|
3.700 10^9/L
n=17 Participants
|
|
Bone Marrow (BM) Myeloblasts Count
|
57.5 Percent of Myeloblasts
n=16 Participants • Participants with available data.
|
|
Number of Participants With at Least One Cytogenetic Abnormality
t(8;21)
|
1 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
+8
|
1 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
complex (>/= 3 abnormalities)
|
5 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
-7
|
1 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
7q-
|
2 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
11q 23 abnormalities
|
3 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
inv (3)
|
1 Participants
n=17 Participants
|
|
Number of Participants With at Least One Cytogenetic Abnormality
Other
|
9 Participants
n=17 Participants
|
|
Number of Prior Systemic Anti-Cancer Regimens
|
5 regimens
n=17 Participants
|
PRIMARY outcome
Timeframe: From day of the first dose of IP to end of cycle 4; Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3, and 4 and at treatment discontinuation.Population: The Intent to Treat (ITT) population consisted of all enrolled participants regardless of whether they received lenalidomide. Analysis was not completed due to scarcity of relevant data. See description.
The morphological complete response rate was defined as the total number of participants with morphological CR observed within the first 4 cycles of lenalidomide (regardless of whether the CR/CRi was observed at the end of Cycle 1, 2, 3 or 4) over the total number of participants evaluable for this endpoint. According to Modified IWG criteria, morphologic CR was defined as: 1. Absolute neutrophil count (ANC) ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (i.e., no transfusion or exogenous growth factor within 7 days of assessment; 2. Bone marrow \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. Morphologic CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
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|---|---|
|
Number of Participants Who Achieved a Morphologic Complete Response Within the First Four Cycles of Lenalidomide Treatment According to the Modified International Working Group (IWG) Criteria
|
1 Participants
Interval 0.1 to 28.7
|
SECONDARY outcome
Timeframe: From date of confirmed complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017Population: Due to scarcity of relevant data, it was not practical or meaningful to analyze the durable response rate. See description.
Durable response rate was defined as the percentage of participants who achieved a BM confirmed CR/CRi according to the Modified IWG Response Assessment Lasting 3 Months (from the time to complete response observed until treatment failure or worse) or until transplantation if earlier among all participants eligible for durable response rate analysis, provided the CR/CRi was confirmed in a bone marrow sample). Due to scarcity of relevant data, it was not practical or meaningful to analyze the durable response rate. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first time of complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017Population: ITT population participants that achieved at least a CR or CRi.
Duration of response was defined as the time from date of the first observed response (CR, CRi or PR) until morphologic relapse, molecular/cytogenetic relapse, or death only for participants who achieved a response. Due to scarcity of relevant data, it was not practical or meaningful to analyze the duration of response. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.Population: Intent to Treat Population consisted of all enrolled participants regardless of whether they received lenalidomide.
Overall response rate was defined as the number of participants with best response of CR, CRi or PR. A CR was defined as: 1. ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment); 2. BM \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. A CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. A PR was defined as: 1. ANC of ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment); 2. BM with 5% to 25% blasts and at least a 50% decrease in BM blast percent from baseline; 3. No evidence of extramedullary disease.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
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|---|---|
|
Number of Participants Who Achieved a Best Response of Morphologic Complete Remission, Morphologic Complete Remission Incomplete or Partial Remission
|
1 Participants
|
SECONDARY outcome
Timeframe: Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.Population: The intent to treat population consisted of all enrolled participants regardless of whether they received lenalidomide. Data are reported for participants who began each treatment cycle.
Disease assessment outcome at the end of Cycles 1-3 based on Cheson criteria: Morphologic CR = 1. ANC ≥ 1000/μL and platelet ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment) 2. BM \< 5% blasts evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease Morphologic CRi = 1\. ANC\< 1000/μL and Platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment) 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease PR = 1. ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support 2. BM with \< 5%-25% blasts and at least a 50% decrease in BM blast percent from baseline 3. No evidence of extramedullary disease Treatment Failure = resistant disease; survival ≥ 7 days post-therapy; failed to achieve CR, CRi, or PR but stable with persistent AML
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
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|---|---|
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Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 1 Morphologic CRi
|
0 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 1 PR
|
1 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 1 Treatment Failure
|
13 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 2 Morphologic CRi
|
1 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 3 Morphologic CRi
|
1 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 3 Treatment Failure
|
0 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 1 Morphologic CR
|
0 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 2 Morphologic CR
|
0 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 2 PR
|
0 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 2 Treatment Failure
|
5 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 3 Morphologic CR
|
0 Participants
|
|
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
Cycle 3 PR
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 5 years post HSCTPopulation: The intent to treat population consisted of all enrolled participants regardless of whether they received lenalidomide.
The number of participants who had undergone a haematopoietic stem cell transplant was calculated over the total number of participants in the ITT population. Percentages were also calculated based on whether the transplantation was the first, second, or subsequent transplant post IP administration.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
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|---|---|
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Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)
Any Transplant After Treatment Start
|
2 Participants
|
|
Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)
First Transplant After Treatment Start
|
2 Participants
|
|
Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)
Second Transplant After Treatment Start
|
0 Participants
|
|
Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)
Any Subsequent Transplant After Treatment Start
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug until 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum duration of treatment was 12 weeksPopulation: The safety population consisted of all participants who received at least one dose of lenalidomide.
A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of lenalidomide and within 28 days after the last dose. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
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|---|---|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any TEAE
|
17 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any TEAE Related to Lenalidomide
|
15 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any Grade 3/4 TEAE
|
17 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any Grade 3/4 TEAE Related to Lenalidomide
|
11 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any Grade 5 TEAE
|
1 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any Serious TEAE
|
13 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any Serious TEAE Related to Lenalidomide
|
5 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any Serious TEAE Leading to Dose Discontinuation
|
3 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any TEAE Leading to Dose Discontinuation
|
3 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any TEAE Leading to Dose Reduction
|
4 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any TEAE Leading to Dose Interruption
|
7 Participants
|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
Any TEAE Leading to Death
|
1 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug to 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum treatment was 12 weeksPopulation: The Safety population consisted of all participants who received at least 1 dose of lenalidomide.
Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Percentage of Participants With of Graft Versus Host Disease (GVHD)
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic (PK) sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Lenalidomide (AUC-t)
|
5378.83 ng*h/mL
Geometric Coefficient of Variation 57.3
|
SECONDARY outcome
Timeframe: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Area Under the Plasma Concentration Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0∞) Of Lenalidomide
|
5656.67 ng*h/mL
Geometric Coefficient of Variation 52.8
|
SECONDARY outcome
Timeframe: PK sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Maximum Observed Concentration (Cmax) of Lenalidomide
|
1252.08 ng/mL
Geometric Coefficient of Variation 43.8
|
SECONDARY outcome
Timeframe: Pk sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Time to cmax was obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Time to Reach Maximum Concentration (Tmax) of Lenalidomide
|
2.000 Hours
Interval 0.55 to 4.0
|
SECONDARY outcome
Timeframe: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Terminal phase half-life in plasma, calculated as \[(ln 2)/λz\]. Terminal half-life was only calculated when a reliable estimate for λz could be obtained.
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Terminal Half-Life (t1/2) of Lenalidomide
|
2.311 hours
Geometric Coefficient of Variation 43.3
|
SECONDARY outcome
Timeframe: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Apparent volume of distribution, calculated as \[(CL/F)/λz\].
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Apparent Total Clearance (CL/F) of Lenalidomide
|
172.09 ml/min
Geometric Coefficient of Variation 52.5
|
SECONDARY outcome
Timeframe: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.Population: The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.
Apparent volume of distribution, calculated as \[(CL/F)/λz\].
Outcome measures
| Measure |
Lenalidomide
n=17 Participants
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Apparent Volume of Distribution (Vz/F) of Lenalidomide
|
34.42 Liters
Geometric Coefficient of Variation 57.0
|
SECONDARY outcome
Timeframe: Not PerformedPopulation: Due to scarcity of relevant data, it was not practical or meaningful to analyze or perform the analysis on blood counts and response to lenalidomide.
Correlation of peripheral white blood cell count, absolute blast count and cytogenetics with response to lenalidomide was not performed since only 1 participant met the primary efficacy endpoint of morphological CR/CRi, and due to scarcity of relevant data, it was not practical or meaningful to analyze to perform the analysis on blood counts and response to lenalidomide.
Outcome measures
Outcome data not reported
Adverse Events
Lenalidomide
Serious events: 13 serious events
Other events: 17 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Lenalidomide
n=17 participants at risk
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
35.3%
6/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Eye disorders
Vitreous haemorrhage
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
General physical health deterioration
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Cellulitis
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Lung infection
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Pneumonia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
International normalised ratio increased
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Renal and urinary disorders
Renal failure
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
Other adverse events
| Measure |
Lenalidomide
n=17 participants at risk
Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
58.8%
10/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
58.8%
10/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Cardiac disorders
Tachycardia
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Eye disorders
Diplopia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Eye disorders
Photophobia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Eye disorders
Vision blurred
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
35.3%
6/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Constipation
|
41.2%
7/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Oral pain
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Proctalgia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Catheter site haematoma
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Face oedema
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Fatigue
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Non-cardiac chest pain
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Oedema peripheral
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Pain
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Peripheral swelling
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
General disorders
Pyrexia
|
41.2%
7/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Staphylococcal infection
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Injury, poisoning and procedural complications
Skin wound
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Anti-platelet antibody positive
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Blood fibrinogen decreased
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Electrocardiogram QT prolonged
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
International normalised ratio increased
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
52.9%
9/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
29.4%
5/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Headache
|
35.3%
6/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Lethargy
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Product Issues
Device issue
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Product Issues
Device occlusion
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Product Issues
Thrombosis in device
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Psychiatric disorders
Phonophobia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Renal and urinary disorders
Chromaturia
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Renal and urinary disorders
Urinary hesitation
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
3/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
29.4%
5/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
11.8%
2/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
29.4%
5/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosur
Celgene Corporation
Phone: 888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 30 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 60 additional days. Investigator must delete confidential data before submission or defer publication to permit patent applications.
- Publication restrictions are in place
Restriction type: OTHER