NCT01495598 · STUDY IN CONTEXT

Pomalidomide for Kaposi Sarcoma in People With or Without HIV

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.

Source null

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primary · POSTED

PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.

Source null

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primary · POSTED

Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California).

Source null

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primary · POSTED

Time to maximum observed serum concentration of Pomalidomide was reported.

Source null

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primary · POSTED

Area under the plasma concentration versus time curve (AUC) was calculated using the log-linear trapezoidal method. The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Source null

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primary · POSTED

AUC is a measure of the serum concentration of Pomalidomide over time. It is used to characterize drug absorption. The AUC extrapolated to infinity was used, unless the percent extrapolated exceeded 25% in which case AUC to the last quantifiable time point (AUCLast) was used. The steady-state exposure on Day 15 of cycle 1 was calculated using AUCLast.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-kaposi-sarcoma
nct id: NCT01495598
qol key: qol-0009
source section id: NCT01495598-om-0009
source outcome index: 9
instrument: Unnamed quality-of-life measure
instrument basis: matched 'health-related quality' in the study's own wording
scale title: Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI)
measure definition: Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses.
time frame: Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores indicating better
population note: Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17).
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Unnamed quality-of-life measure · Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-kaposi-sarcoma
nct id: NCT01495598
qol key: qol-0010
source section id: NCT01495598-om-0010
source outcome index: 10
instrument: Unnamed quality-of-life measure
instrument basis: matched 'health-related quality' in the study's own wording
scale title: Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
measure definition: The number of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
time frame: Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other three participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Unnamed quality-of-life measure · Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-kaposi-sarcoma
nct id: NCT01495598
qol key: qol-0015
source section id: NCT01495598-om-0015
source outcome index: 15
instrument: Unnamed quality-of-life measure
instrument basis: matched 'health-related quality' in the study's own wording
scale title: Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
measure definition: The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
time frame: Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other 3 participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-kaposi-sarcoma
nct id: NCT01495598
trial label: Pomalidomide for Kaposi Sarcoma in People With or Without HIV
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 1
qol Count: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0000
source section id
NCT01495598-om-0000
source outcome index
0
endpoint
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide
endpoint definition
Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.
time origin
During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0001
source section id
NCT01495598-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS)
endpoint definition
PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
time origin
time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0002
source section id
NCT01495598-om-0002
source outcome index
2
endpoint
Maximal Plasma Concentration (Cmax) of Pomalidomide
endpoint definition
Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California).
time origin
At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0003
source section id
NCT01495598-om-0003
source outcome index
3
endpoint
Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax)
endpoint definition
Time to maximum observed serum concentration of Pomalidomide was reported.
time origin
At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0004
source section id
NCT01495598-om-0004
source outcome index
4
endpoint
Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast)
endpoint definition
Area under the plasma concentration versus time curve (AUC) was calculated using the log-linear trapezoidal method. The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
time origin
At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0005
source section id
NCT01495598-om-0005
source outcome index
5
endpoint
Area Under the Curve Extrapolated to Infinity (AUCinf)
endpoint definition
AUC is a measure of the serum concentration of Pomalidomide over time. It is used to characterize drug absorption. The AUC extrapolated to infinity was used, unless the percent extrapolated exceeded 25% in which case AUC to the last quantifiable time point (AUCLast) was used. The steady-state exposure on Day 15 of cycle 1 was calculated using AUCLast.
time origin
At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0000
arm key
OG000
arm label
Grade 1
regimen
Grade 1 is mild.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0000
arm key
OG001
arm label
Grade 2
regimen
Grade 2 is moderate.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0000
arm key
OG002
arm label
Grade 3
regimen
Grade 3 is severe.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0000
arm key
OG003
arm label
Grade 4
regimen
Grade 4 is life-threatening.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0001
arm key
OG000
arm label
All Participants
regimen
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0001
arm key
OG001
arm label
HIV Positive Participants
regimen
HIV positive participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0001
arm key
OG002
arm label
HIV Negative Participants
regimen
HIV negative participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0002
arm key
OG000
arm label
All Participants - Pomalidomide 5mg Daily
regimen
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0003
arm key
OG000
arm label
All Participants - Pomalidomide 5mg Daily
regimen
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0004
arm key
OG000
arm label
All Participants - Pomalidomide 5mg Daily
regimen
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
outcome key
om-0005
arm key
OG000
arm label
All Participants - Pomalidomide 5mg Daily
regimen
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01495598-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
harm key
EG000
source section id
NCT01495598-ae
event group key
EG000
event group label
Pomalidomide 5mg Daily
serious affected
12
serious at risk
28
other affected
28
other at risk
28
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 124 months and 1 day.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
qol key
qol-0009
source section id
NCT01495598-om-0009
source outcome index
9
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health-related quality' in the study's own wording
scale title
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI)
measure definition
Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses.
time frame
Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating better
population note
Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
qol key
qol-0010
source section id
NCT01495598-om-0010
source outcome index
10
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health-related quality' in the study's own wording
scale title
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
measure definition
The number of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
time frame
Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other three participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-kaposi-sarcoma
nct id
NCT01495598
qol key
qol-0015
source section id
NCT01495598-om-0015
source outcome index
15
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health-related quality' in the study's own wording
scale title
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
measure definition
The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
time frame
Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other 3 participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice