NCT00142168 · STUDY IN CONTEXT

CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia

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.

primary · POSTED

Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.

All enrolled patients

→

primary · POSTED

Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a \> 50% and \> 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having \< 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.

Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.

→

secondary · POSTED

Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a \>50% reduction in serum IgM levels.

Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.

→

secondary · POSTED

A minor response is defined as having achieved \>25% but less than 50% reduction in serum IgM levels.

Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.

→

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-indolent-b-cell-non-hodgkin-lymphoma
nct id: NCT00142168
trial label: CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0000
source section id
NCT00142168-om-0000
source outcome index
0
endpoint
Time to Progression
endpoint definition
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
time origin
34.3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled 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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0001
source section id
NCT00142168-om-0001
source outcome index
1
endpoint
Overall Response
endpoint definition
Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a \> 50% and \> 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having \< 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.
time origin
34.3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0002
source section id
NCT00142168-om-0002
source outcome index
2
endpoint
Major Response Rate
endpoint definition
Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a \>50% reduction in serum IgM levels.
time origin
34.3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0003
source section id
NCT00142168-om-0003
source outcome index
3
endpoint
Minor Response Rate
endpoint definition
A minor response is defined as having achieved \>25% but less than 50% reduction in serum IgM levels.
time origin
34.3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
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-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0000
arm key
OG000
arm label
Lenalidomide and Rituximab
regimen
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00142168-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0001
arm key
OG000
arm label
Lenalidomide and Rituximab
regimen
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00142168-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0002
arm key
OG000
arm label
Lenalidomide and Rituximab
regimen
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00142168-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
outcome key
om-0003
arm key
OG000
arm label
Lenalidomide and Rituximab
regimen
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00142168-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma
nct id
NCT00142168
harm key
EG000
source section id
NCT00142168-ae
event group key
EG000
event group label
Lenalidomide and Rituximab
serious affected
11
serious at risk
16
other affected
8
other at risk
16
frequency threshold
5
collection period
Source null
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