NCT01570387 · STUDY IN CONTEXT

A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis

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. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis

Source null

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primary · POSTED

Number of patients in Phase I cohort 2 experiencing dose limiting toxicity in the 3 milligram dose level, cohort 2.

Source null

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primary · POSTED

Number of patients in Phase I cohort 3 experiencing dose-limiting toxicity at the 4 milligram dose for participants within the third dose cohort

Source null

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secondary · POSTED

Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses)

Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-al-amyloidosis
nct id: NCT01570387
trial label: A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
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.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT01570387
outcome key
om-0000
source section id
NCT01570387-om-0000
source outcome index
0
endpoint
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose
endpoint definition
Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis
time origin
one month
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-al-amyloidosis
nct id
NCT01570387
outcome key
om-0001
source section id
NCT01570387-om-0001
source outcome index
1
endpoint
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose
endpoint definition
Number of patients in Phase I cohort 2 experiencing dose limiting toxicity in the 3 milligram dose level, cohort 2.
time origin
One month
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-al-amyloidosis
nct id
NCT01570387
outcome key
om-0002
source section id
NCT01570387-om-0002
source outcome index
2
endpoint
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose
endpoint definition
Number of patients in Phase I cohort 3 experiencing dose-limiting toxicity at the 4 milligram dose for participants within the third dose cohort
time origin
One month
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-al-amyloidosis
nct id
NCT01570387
outcome key
om-0003
source section id
NCT01570387-om-0003
source outcome index
3
endpoint
Response to the Maximal Tolerated Dose
endpoint definition
Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses)
time origin
one year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants
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-al-amyloidosis
nct id
NCT01570387
outcome key
om-0000
arm key
OG000
arm label
Pom Plus Dex
regimen
Pomalidomide dexamethasone Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28 Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01570387-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT01570387
outcome key
om-0001
arm key
OG000
arm label
Pom Plus Dex
regimen
Pomalidomide dexamethasone Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28 Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01570387-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT01570387
outcome key
om-0002
arm key
OG000
arm label
Pom Plus Dex
regimen
Pomalidomide dexamethasone Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28 Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01570387-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT01570387
outcome key
om-0003
arm key
OG000
arm label
Pom Plus Dex
regimen
Pomalidomide dexamethasone Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28 Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01570387-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT01570387
harm key
EG000
source section id
NCT01570387-ae
event group key
EG000
event group label
Phase I - Cohort 1 (Pomalidomide 2mg)
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
6 years
event definition
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
undenominated 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-al-amyloidosis
nct id
NCT01570387
harm key
EG001
source section id
NCT01570387-ae
event group key
EG001
event group label
Phase I - Cohort 2 (Pomalidomide 3mg)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
6 years
event definition
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
undenominated 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-al-amyloidosis
nct id
NCT01570387
harm key
EG002
source section id
NCT01570387-ae
event group key
EG002
event group label
Phase I - Cohort 3 (Pomalidomide 4mg)
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
6 years
event definition
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
undenominated 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-al-amyloidosis
nct id
NCT01570387
harm key
EG003
source section id
NCT01570387-ae
event group key
EG003
event group label
Phase II Expansion- Maximum Tolerated Dose
serious affected
3
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
6 years
event definition
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
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

setting source links

Preserved source evidence · Not medical advice