Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)

Patients who had received at least one prior line of therapy

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primary · POSTED

Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)

Participants who were previously untreated.

→

secondary · POSTED

Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.

All enrolled participants.

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secondary · POSTED

Time from documentation of first response to progressive disease.

All participants enrolled

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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-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
nct id: NCT00422799
trial label: Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0000
source section id
NCT00422799-om-0000
source outcome index
0
endpoint
Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM)
endpoint definition
Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
time origin
2 Years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who had received at least one prior line of therapy
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-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0001
source section id
NCT00422799-om-0001
source outcome index
1
endpoint
Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM)
endpoint definition
Overall Response Rate= Minor response (\>25%-50% reduction in monoclonal IgM from baseline + Partial Response (\>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)
time origin
2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who were previously untreated.
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-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0002
source section id
NCT00422799-om-0002
source outcome index
2
endpoint
Time to Progression in Patients With WM
endpoint definition
Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.
time origin
5 Years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants.
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-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0003
source section id
NCT00422799-om-0003
source outcome index
3
endpoint
Duration of Response in Patients With WM
endpoint definition
Time from documentation of first response to progressive disease.
time origin
5 Years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants enrolled
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-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0000
arm key
OG000
arm label
Bortezomib and Rituximab
regimen
bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00422799-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0001
arm key
OG000
arm label
Bortezomib and Rituximab
regimen
bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00422799-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0002
arm key
OG000
arm label
Bortezomib and Rituximab
regimen
bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00422799-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
nct id
NCT00422799
outcome key
om-0003
arm key
OG000
arm label
Bortezomib and Rituximab
regimen
bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00422799-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
nct id
NCT00422799
harm key
EG000
source section id
NCT00422799-ae
event group key
EG000
event group label
Bortezomib and Rituximab
serious affected
11
serious at risk
63
other affected
63
other at risk
63
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