NCT00790842 · STUDY IN CONTEXT

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction

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

Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: * Grade 3 or higher neutropenia with fever ≥38.5 degrees C * Grade 4 neutropenia ≥7 days * Grade 4 or higher thrombocytopenia * Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause

Patients treated during the dose finding phase of the study

→

primary · POSTED

Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, \<5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \< 200 mg per 24 hours, \>=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, \>=50% reduction in bone marrow plasma cells, if baseline percentage was \>=30%, \>=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components

Patients treated at the recommended phase II dose

→

secondary · POSTED

Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.

Eligible, treated patients

→

secondary · POSTED

Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.

Patients treated at the recommended phase II dose who experienced a response to treatment

→

secondary · POSTED

The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.

All patients who started treatment

→

secondary · POSTED

To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.

This outcome was not analyzed because the dose increase was not implemented.

→

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: NCT00790842
trial label: Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction
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: 6
harms Count: 13
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
source section id
NCT00790842-om-0000
source outcome index
0
endpoint
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
endpoint definition
Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: * Grade 3 or higher neutropenia with fever ≥38.5 degrees C * Grade 4 neutropenia ≥7 days * Grade 4 or higher thrombocytopenia * Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
time origin
First cycle of therapy (28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients treated during the dose finding phase of the study
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
NCT00790842
outcome key
om-0001
source section id
NCT00790842-om-0001
source outcome index
1
endpoint
Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
endpoint definition
Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, \<5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \< 200 mg per 24 hours, \>=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, \>=50% reduction in bone marrow plasma cells, if baseline percentage was \>=30%, \>=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components
time origin
56 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients treated at the recommended phase II dose
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
NCT00790842
outcome key
om-0002
source section id
NCT00790842-om-0002
source outcome index
2
endpoint
Overall Survival Time
endpoint definition
Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
time origin
56 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible, treated patients
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
NCT00790842
outcome key
om-0003
source section id
NCT00790842-om-0003
source outcome index
3
endpoint
Duration of Response
endpoint definition
Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.
time origin
56 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients treated at the recommended phase II dose who experienced a response to treatment
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
NCT00790842
outcome key
om-0004
source section id
NCT00790842-om-0004
source outcome index
4
endpoint
Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
endpoint definition
The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
time origin
56 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who started treatment
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
NCT00790842
outcome key
om-0005
source section id
NCT00790842-om-0005
source outcome index
5
endpoint
Renal Function Over Time
endpoint definition
To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.
time origin
56 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This outcome was not analyzed because the dose increase was not implemented.
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
NCT00790842
outcome key
om-0000
arm key
OG000
arm label
Group A Lenalidomide 10 mg/Day
regimen
CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG001
arm label
Group A Lenalidomide 15 mg/Day
regimen
CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG002
arm label
Group A Lenalidomide 25 mg/Day
regimen
CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG003
arm label
Group B Lenalidomide 15 mg/2 Days
regimen
CrCl\<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG004
arm label
Group B Lenalidomide 25 mg/2 Days
regimen
CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG005
arm label
Group B Lenalidomide 15 mg/Day
regimen
CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG006
arm label
Group B Lenalidomide 25 mg/Day
regimen
CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG007
arm label
Group C Lenalidomide 15 mg 3x/Week
regimen
CrCl \< 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG008
arm label
Group C Lenalidomide 10 mg/Day
regimen
CrCl \< 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG009
arm label
Group C Lenalidomide 15 mg/Day
regimen
CrCl \< 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0000
arm key
OG010
arm label
Group C Lenalidomide 25 mg/Day
regimen
CrCl \< 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
outcome key
om-0001
arm key
OG000
arm label
Group A CrCl 30-60 mL/Min
regimen
Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00790842-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG000
source section id
NCT00790842-ae
event group key
EG000
event group label
Group A Lenalidomide 10 mg/Day
serious affected
5
serious at risk
6
other affected
5
other at risk
6
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG001
source section id
NCT00790842-ae
event group key
EG001
event group label
Group A Lenalidomide 15 mg/Day
serious affected
2
serious at risk
3
other affected
2
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG002
source section id
NCT00790842-ae
event group key
EG002
event group label
Group A Lenalidomide 25 mg/Day
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG003
source section id
NCT00790842-ae
event group key
EG003
event group label
Group A Expansion Cohort
serious affected
10
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG004
source section id
NCT00790842-ae
event group key
EG004
event group label
Group B Lenalidomide 15 mg/2 Days
serious affected
3
serious at risk
3
other affected
1
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG005
source section id
NCT00790842-ae
event group key
EG005
event group label
Group B Lenalidomide 25 mg/2 Days
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG006
source section id
NCT00790842-ae
event group key
EG006
event group label
Group B Lenalidomide 15 mg/Day
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG007
source section id
NCT00790842-ae
event group key
EG007
event group label
Group B Lenalidomide 25 mg/Day
serious affected
5
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG008
source section id
NCT00790842-ae
event group key
EG008
event group label
Group B Expansion Cohort
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG009
source section id
NCT00790842-ae
event group key
EG009
event group label
Group C Lenalidomide 15 mg 3x/wk
serious affected
2
serious at risk
3
other affected
1
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG010
source section id
NCT00790842-ae
event group key
EG010
event group label
Group C Lenalidomide 10 mg/Day
serious affected
3
serious at risk
3
other affected
2
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of 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-plasma-cell-neoplasms
nct id
NCT00790842
harm key
EG011
source section id
NCT00790842-ae
event group key
EG011
event group label
Group C Lenalidomide 15 mg/Day
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
event definition
Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice