Trial · NCT00422799
Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
NCT00422799, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2018-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM). Trials, record NCT00422799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422799
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
- NCT number
- NCT00422799
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Waldenstrom's Macroglobulinemia
- Interventions
- Bortezomib, Rituximab
- First posted
- 2007-01-17
- Last updated
- 2020-10-27
- Results first posted
- 2018-01-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM) | 2 Years | 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.) |
| Primary | Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM) | 2 years | 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.) |
| Secondary | Time to Progression in Patients With WM | 5 Years | 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. |
| Secondary | Duration of Response in Patients With WM | 5 Years | Time from documentation of first response to progressive disease. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM) | 2 Years | Patients who had received at least one prior line of therapy | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM) | 2 years | Participants who were previously untreated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression in Patients With WM | 5 Years | All enrolled participants. | years | MEDIAN |
| SECONDARY | Duration of Response in Patients With WM | 5 Years | All participants enrolled | years | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia (WM) | Bortezomib and Rituximab | 30 | Participants | ||
| Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated Waldenstrom's Macroglobulinemia (WM) | Bortezomib and Rituximab | 23 | Participants | ||
| Time to Progression in Patients With WM | Bortezomib and Rituximab | 1.6 | 95% Confidence Interval 1.1 to 5 | years | |
| Duration of Response in Patients With WM | Bortezomib and Rituximab | 1.4 | 95% Confidence Interval 0.6 to 5 | years |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bortezomib and Rituximab | 63 | |
| Overall Study | COMPLETED | Bortezomib and Rituximab | 50 | |
| Overall Study | NOT COMPLETED | Bortezomib and Rituximab | 13 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Edema limb | General disorders | Bortezomib and Rituximab | 7 | 63 | 7 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Bortezomib and Rituximab | 4 | 63 | 4 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Bortezomib and Rituximab | 5 | 63 | 5 |
| other | Upper airway infection | Infections and infestations | Bortezomib and Rituximab | 4 | 63 | 4 |
| other | Joint pain | Musculoskeletal and connective tissue disorders | Bortezomib and Rituximab | 6 | 63 | 6 |
| other | Muscle pain | Musculoskeletal and connective tissue disorders | Bortezomib and Rituximab | 5 | 63 | 5 |
| other | Allergic reaction | Immune system disorders | Bortezomib and Rituximab | 20 | 63 | 20 |
| other | Dizziness | Nervous system disorders | Bortezomib and Rituximab | 7 | 63 | 7 |
| other | Neuropathy-sensory | Nervous system disorders | Bortezomib and Rituximab | 32 | 63 | 32 |
| other | ALT elevation | Investigations | Bortezomib and Rituximab | 6 | 63 | 6 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib and Rituximab | 1 | 63 |
| Total, other adverse events | Bortezomib and Rituximab | 63 | 63 |
| Total, serious adverse events | Bortezomib and Rituximab | 11 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20142586 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00422799
GET https://conductscience.org/api/trials/v1/NCT00422799/events?page=2