Trial Outcomes & Findings for Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma (NCT NCT02011113)
NCT ID: NCT02011113
Last Updated: 2016-11-01
Results Overview
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
COMPLETED
PHASE2
36 participants
From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.
2016-11-01
Participant Flow
All study participants who were on pomalidomide were transferred to the post-marketing study and continued the study treatment when pomalidomide became commercially available.
Treatment phase discontinuation occurred when a participant had confirmed progressive disease, development of unacceptable toxicity, voluntary withdrawal or met other criteria for treatment discontinuation.
Participant milestones
| Measure |
Pomalidomide Plus Dexamethasone
Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are \> 75 years of age
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Pomalidomide Plus Dexamethasone
Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are \> 75 years of age
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Disease Progression (DP)
|
16
|
|
Overall Study
Death
|
1
|
|
Overall Study
Insufficient effect of Pomalidomide
|
1
|
|
Overall Study
Investigator's judgement- DP
|
3
|
|
Overall Study
Study terminated by sponsor
|
11
|
Baseline Characteristics
Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
|
|---|---|
|
Age, Continuous
|
64.5 years
n=5 Participants
|
|
Age, Customized
≤ 75 Years Old
|
32 participants
n=5 Participants
|
|
Age, Customized
> 75 Years Old
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Time from first diagnosis
|
4.65 years
n=5 Participants
|
|
Durie-Salmon Multiple myeloma staging at screening
Stage I
|
7 participants
n=5 Participants
|
|
Durie-Salmon Multiple myeloma staging at screening
Stage II
|
16 participants
n=5 Participants
|
|
Durie-Salmon Multiple myeloma staging at screening
Stage III
|
13 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status] (ECOG)
0 = (Asymptomatic)
|
17 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status] (ECOG)
1 = (Symptomatic but completely ambulatory)
|
16 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status] (ECOG)
2 = (Ambulatory but unable to work)
|
3 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status] (ECOG)
3 = (Limited self-care)
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status] (ECOG)
4 = (Completely disabled)
|
0 participants
n=5 Participants
|
|
Prior Chemotherapy Regimens
|
6.0 regimens
n=5 Participants
|
|
Prior Stem Cell Transplant for Myeloma
Yes
|
19 participants
n=5 Participants
|
|
Prior Stem Cell Transplant for Myeloma
No
|
17 participants
n=5 Participants
|
|
Durie-Salmon Multiple Myeloma staging at screening
Stage I
|
7 participants
n=5 Participants
|
|
Durie-Salmon Multiple Myeloma staging at screening
Stage II
|
16 participants
n=5 Participants
|
|
Durie-Salmon Multiple Myeloma staging at screening
Stage III
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.Population: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
|
25.0 percentage of participants responding
Interval 10.855 to 39.145
|
PRIMARY outcome
Timeframe: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeksPopulation: Efficacy Evaluable Population (EEP) includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)
|
41.7 percentage of participants responding
Interval 25.562 to 57.771
|
SECONDARY outcome
Timeframe: From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeksPopulation: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - \<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to \< 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria
|
22.2 percentage of participants responding
Interval 8.642 to 35.803
|
SECONDARY outcome
Timeframe: From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.Population: Included participants with at least a PR or better based on Assessment using IMWG criteria.
Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=9 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Time to Response
|
4.10 weeks
Interval 4.1 to 24.1
|
SECONDARY outcome
Timeframe: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeksPopulation: EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - \<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to \< 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)
|
38.9 percentage of participants responding
Interval 22.964 to 54.814
|
SECONDARY outcome
Timeframe: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeksPopulation: Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.
Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=15 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Time to Response (Later Cut-off Date)
|
8.10 weeks
Interval 4.1 to 24.1
|
SECONDARY outcome
Timeframe: From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeksPopulation: Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.
Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeksPopulation: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=15 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)
|
NA weeks
Interval 20.1 to
The median duration of response based on Kaplan-Meier estimate had not been reached. The upper limit was not calculable because an insufficient number of participants reached the event at the time point for the assessment.
|
SECONDARY outcome
Timeframe: From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeksPopulation: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
|
19.0 weeks
Interval 8.1 to
The upper limit was not calculable because an insufficient number of participants reached the event at the time point for assessment
|
SECONDARY outcome
Timeframe: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeksPopulation: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Kaplan-Meier Estimates of PFS (Later Cut-off Date)
|
32.10 weeks
Interval 9.7 to
The upper limit was not calculable because an insufficient number of participants reached the event at the time point for the assessment.
|
SECONDARY outcome
Timeframe: From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeksPopulation: Safety population includes all participants who took at least one dose of study medication.
Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 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. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.
Outcome measures
| Measure |
Pomalidomide Plus Dexamethasone
n=36 Participants
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
|
|---|---|
|
Number of Participants With Adverse Events
Any 1 TEAE
|
36 participants
|
|
Number of Participants With Adverse Events
TEAE related to any study drugs
|
33 participants
|
|
Number of Participants With Adverse Events
TEAE related to Pomalidomide
|
33 participants
|
|
Number of Participants With Adverse Events
TEAE related to Dexamethasone(Dex)
|
27 participants
|
|
Number of Participants With Adverse Events
TEAE with ≥ Grade (GR) 3
|
33 participants
|
|
Number of Participants With Adverse Events
≥ 1TEAE ≥ GR 3 related to any study drug
|
30 participants
|
|
Number of Participants With Adverse Events
TEAE ≥ GR 3 related to Pomalidomide
|
30 participants
|
|
Number of Participants With Adverse Events
TEAE ≥ GR 3 related to Dexamethasone
|
11 participants
|
|
Number of Participants With Adverse Events
≥ 1 serious TEAE
|
16 participants
|
|
Number of Participants With Adverse Events
Serious TEAE related to any study drug
|
8 participants
|
|
Number of Participants With Adverse Events
Serious TEAE related to Pomalidomide
|
8 participants
|
|
Number of Participants With Adverse Events
Serious TEAE related to Dexamethasone
|
6 participants
|
|
Number of Participants With Adverse Events
TEAE leading to stopping of any study drug
|
5 participants
|
|
Number of Participants With Adverse Events
TEAE leading to discontinuation of Pomalidomide
|
5 participants
|
|
Number of Participants With Adverse Events
TEAE leading to discontinuation of Dexamethasone
|
5 participants
|
|
Number of Participants With Adverse Events
Related TEAE leading to stopping of study drug
|
4 participants
|
|
Number of Participants With Adverse Events
Related TEAE leading to stopping of Pomalidomide
|
4 participants
|
|
Number of Participants With Adverse Events
Related TEAE leading to stopping Dexamethasone
|
4 participants
|
|
Number of Participants With Adverse Events
TEAE leading to dose reduction of any study drug
|
19 participants
|
|
Number of Participants With Adverse Events
TEAE leading to dose reduction of Pomalidomide
|
10 participants
|
|
Number of Participants With Adverse Events
TEAE leading to dose reduction of Dexamethasone
|
15 participants
|
|
Number of Participants With Adverse Events
TEA leading to dose interruption of any study drug
|
20 participants
|
|
Number of Participants With Adverse Events
TEAE leading to dose interruption of Pomalidomide
|
18 participants
|
|
Number of Participants With Adverse Events
TEAE leading to dose interruption of Dexamethasone
|
11 participants
|
|
Number of Participants With Adverse Events
Related TEAE leading to dose reduction of any drug
|
18 participants
|
|
Number of Participants With Adverse Events
Related TEAE causing a dose reduction Pomalidomide
|
10 participants
|
|
Number of Participants With Adverse Events
≥1 related TEAE causing a dose reduction: Dex
|
14 participants
|
|
Number of Participants With Adverse Events
Related TEAE leading to interruption of drugs
|
16 participants
|
|
Number of Participants With Adverse Events
Related TEAE causing an interruption Pomalidomide
|
15 participants
|
|
Number of Participants With Adverse Events
Related TEAE causing an interruption to Dex
|
8 participants
|
|
Number of Participants With Adverse Events
TEAE Grade 5
|
3 participants
|
Adverse Events
Pomalidomide Plus Dexamethasone
Serious adverse events
| Measure |
Pomalidomide Plus Dexamethasone
n=36 participants at risk
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
13.9%
5/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
PNEUMONIA
|
13.9%
5/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
General disorders
MULTI-ORGAN FAILURE
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
General disorders
PYREXIA
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
BLOOD FIBRINOGEN DECREASED
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
BRONCHITIS
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
MENINGITIS
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
SEPSIS
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Cardiac disorders
CARDIAC FAILURE
|
2.8%
1/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
Other adverse events
| Measure |
Pomalidomide Plus Dexamethasone
n=36 participants at risk
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
|
|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
72.2%
26/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
44.4%
16/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Blood and lymphatic system disorders
ANAEMIA
|
47.2%
17/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
22.2%
8/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
16.7%
6/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
General disorders
PYREXIA
|
25.0%
9/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
General disorders
OEDEMA PERIPHERAL
|
19.4%
7/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
General disorders
MALAISE
|
16.7%
6/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
General disorders
FATIGUE
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.0%
9/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
DIARRHOEA
|
19.4%
7/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
NAUSEA
|
19.4%
7/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
PROCTALGIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Gastrointestinal disorders
VOMITING
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Skin and subcutaneous tissue disorders
RASH
|
19.4%
7/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
NASOPHARYNGITIS
|
25.0%
9/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
BRONCHITIS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
PNEUMONIA
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
DYSGEUSIA
|
13.9%
5/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
HYPERSOMNIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
SOMNOLENCE
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
11.1%
4/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Psychiatric disorders
ANXIETY
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
HERPES ZOSTER
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
CYSTITIS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
GASTROENTERITIS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
6/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Psychiatric disorders
RESTLESSNESS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
HEADACHE
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Nervous system disorders
TREMOR
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
WEIGHT DECREASED
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Investigations
WEIGHT INCREASED
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Vascular disorders
HYPOTENSION
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
5.6%
2/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
|
Infections and infestations
Pharyngitis
|
8.3%
3/36 • From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
|
Additional Information
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