NCT02547662 · STUDY IN CONTEXT

Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia

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 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.

exploratory · NOT_POSTED

The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve a sCR or CR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.

Source null

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primary · POSTED

A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response (PR), or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Source null

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secondary · POSTED

The biochemical response rate will be estimated by the number of responders(patients that achieved partial or complete response) divided by the number of evaluable patients who have measurable disease by serum M-protein, urine M-protein, or serum FLC assay at baseline. Exact binomial confidence intervals will be calculated.

All patients evaluated for biochemical response

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secondary · POSTED

Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters. The extramedullary response rate will be estimated by the number of responders(patients that achieved a partial or complete response) divided by the number of evaluable patients. Exact binomial confidence intervals will be calculated.

All patients with extramedullary disease that were evaluated for response.

→

secondary · POSTED

Number of patients with adverse events is reported here, the full list of those adverse events and their frequency is reported in the adverse event section.

Source null

→

secondary · POSTED

The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

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

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-plasma-cell-neoplasms
nct id: NCT02547662
trial label: Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
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: 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0005
source section id
NCT02547662-om-0005
source outcome index
5
endpoint
Proportion of Patients Who Achieve Minimal Residual Disease (MRD) Negative Status
endpoint definition
The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve a sCR or CR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.
time origin
Up to 5 years
analysis role
exploratory
reporting status
NOT_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-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0000
source section id
NCT02547662-om-0000
source outcome index
0
endpoint
Confirmed Response Rate
endpoint definition
A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response (PR), or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
4 years
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-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0001
source section id
NCT02547662-om-0001
source outcome index
1
endpoint
Biochemical Response Rate
endpoint definition
The biochemical response rate will be estimated by the number of responders(patients that achieved partial or complete response) divided by the number of evaluable patients who have measurable disease by serum M-protein, urine M-protein, or serum FLC assay at baseline. Exact binomial confidence intervals will be calculated.
time origin
4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients evaluated for biochemical response
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-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0002
source section id
NCT02547662-om-0002
source outcome index
2
endpoint
Extramedullary Response Rate
endpoint definition
Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters. The extramedullary response rate will be estimated by the number of responders(patients that achieved a partial or complete response) divided by the number of evaluable patients. Exact binomial confidence intervals will be calculated.
time origin
4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients with extramedullary disease that were evaluated for response.
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-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0003
source section id
NCT02547662-om-0003
source outcome index
3
endpoint
Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
endpoint definition
Number of patients with adverse events is reported here, the full list of those adverse events and their frequency is reported in the adverse event section.
time origin
4 years 1 month
analysis role
secondary
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-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0004
source section id
NCT02547662-om-0004
source outcome index
4
endpoint
Progression-free Survival
endpoint definition
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
time origin
4 years 8 months
analysis role
secondary
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-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0000
arm key
OG000
arm label
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
regimen
Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02547662-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0001
arm key
OG000
arm label
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
regimen
Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02547662-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0002
arm key
OG000
arm label
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
regimen
Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02547662-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0003
arm key
OG000
arm label
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
regimen
Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02547662-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT02547662
outcome key
om-0004
arm key
OG000
arm label
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
regimen
Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02547662-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT02547662
harm key
EG000
source section id
NCT02547662-ae
event group key
EG000
event group label
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
serious affected
5
serious at risk
17
other affected
17
other at risk
17
frequency threshold
0
collection period
Adverse events were followed for 4 years and 1 month, mortality was followed for 4 years and 8 months.
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

setting source links

Preserved source evidence · Not medical advice