NCT03031730 · STUDY IN CONTEXT

Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)

Only included DLT-evaluable patients. 6 of 6 patients enrolled on Dose Level 1 and 5 of 10 patients at dose level 2 were DLT-evaluable. Therefore, the primary outcome of determining the safety and tolerability beyond dose level one was not possible, and the MTD and recommended phase 2 dose could not be evaluated prior to study closure.

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primary · POSTED

Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)

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secondary · POSTED

Evaluate PD Effects of KRT-232 (AMG 232) Through Serum MIC-1 Levels.

Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.

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secondary · POSTED

Assess KRT-232 (AMG 232) Exposure-response Relationships (PD, Toxicity, and Efficacy).

Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.

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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-refractory-0d6d63cc
nct id: NCT03031730
trial label: Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0000
source section id
NCT03031730-om-0000
source outcome index
0
endpoint
Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
endpoint definition
Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
time origin
at least 6 months of treatment, an average of 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only included DLT-evaluable patients. 6 of 6 patients enrolled on Dose Level 1 and 5 of 10 patients at dose level 2 were DLT-evaluable. Therefore, the primary outcome of determining the safety and tolerability beyond dose level one was not possible, and the MTD and recommended phase 2 dose could not be evaluated prior to study closure.
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-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0001
source section id
NCT03031730-om-0001
source outcome index
1
endpoint
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
endpoint definition
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
time origin
at least 6 months of treatment, an average of 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only included DLT-evaluable patients. 6 of 6 patients enrolled on Dose Level 1 and 5 of 10 patients at dose level 2 were DLT-evaluable. Therefore, the primary outcome of determining the safety and tolerability beyond dose level one was not possible, and the MTD and recommended phase 2 dose could not be evaluated prior to study closure.
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-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0002
source section id
NCT03031730-om-0002
source outcome index
2
endpoint
Evaluate PD Effects of KRT-232 (AMG 232) Through Serum MIC-1 Levels.
endpoint definition
Evaluate PD Effects of KRT-232 (AMG 232) Through Serum MIC-1 Levels.
time origin
30 days after last dose
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
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-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0003
source section id
NCT03031730-om-0003
source outcome index
3
endpoint
Assess KRT-232 (AMG 232) Exposure-response Relationships (PD, Toxicity, and Efficacy).
endpoint definition
Assess KRT-232 (AMG 232) Exposure-response Relationships (PD, Toxicity, and Efficacy).
time origin
30 days after last dose
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
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-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0000
arm key
OG000
arm label
Part A: Dose Level 1
regimen
KRT-232 60 mg + KRd
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0000
arm key
OG001
arm label
Part A: Dose Level 2
regimen
KRT-232 90 mg + KRd
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0001
arm key
OG000
arm label
Part A: Dose Level 1
regimen
KRT-232 60 mg + KRd
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0001
arm key
OG001
arm label
Part A: Dose Level 2
regimen
KRT-232 90 mg + KRd
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0002
arm key
OG000
arm label
Part A: Dose Level 1
regimen
KRT-232 60 mg + KRd
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0002
arm key
OG001
arm label
Part A: Dose Level 2
regimen
KRT-232 90 mg + KRd
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0003
arm key
OG000
arm label
Part A: Dose Level 1
regimen
KRT-232 60 mg + KRd
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
outcome key
om-0003
arm key
OG001
arm label
Part A: Dose Level 2
regimen
KRT-232 90 mg + KRd
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03031730-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
harm key
EG000
source section id
NCT03031730-ae
event group key
EG000
event group label
Part A (Dose-escalation) 60 mg
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
At least 6 months of treatment, an average of 1 year
event definition
No patients were enrolled under Part A (Dose-escalation) 120, 190 and 240 mg.
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-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
harm key
EG001
source section id
NCT03031730-ae
event group key
EG001
event group label
Part A (Dose-escalation) 90 mg
serious affected
7
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
At least 6 months of treatment, an average of 1 year
event definition
No patients were enrolled under Part A (Dose-escalation) 120, 190 and 240 mg.
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-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
harm key
EG002
source section id
NCT03031730-ae
event group key
EG002
event group label
Part A (Dose-escalation) 120 mg
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
At least 6 months of treatment, an average of 1 year
event definition
No patients were enrolled under Part A (Dose-escalation) 120, 190 and 240 mg.
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-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
harm key
EG003
source section id
NCT03031730-ae
event group key
EG003
event group label
Part A (Dose-escalation) 190 mg
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
At least 6 months of treatment, an average of 1 year
event definition
No patients were enrolled under Part A (Dose-escalation) 120, 190 and 240 mg.
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-plasma-cell-neoplasms-refractory-0d6d63cc
nct id
NCT03031730
harm key
EG004
source section id
NCT03031730-ae
event group key
EG004
event group label
Part A (Dose-escalation) 240 mg
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
At least 6 months of treatment, an average of 1 year
event definition
No patients were enrolled under Part A (Dose-escalation) 120, 190 and 240 mg.
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