Trial · NCT00312845
Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
NCT00312845, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2011-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma. Trials, record NCT00312845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00312845
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- NCT number
- NCT00312845
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 676 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Bortezomib + Rituximab, Rituximab
- First posted
- 2006-04-11
- Last updated
- 2012-06-25
- Results first posted
- 2011-07-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. | Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first. |
| Secondary | Overall Response Rate | Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. | Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. | Intention to treat (ITT) population is defined as all patients randomized to the trial. | days | MEDIAN |
| SECONDARY | Overall Response Rate | Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. | The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC. | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Progression Free Survival | Bortezomib + Rituximab | 389 | 95% Confidence Interval 351 to 456 | days | |
| Progression Free Survival | Rituximab | 334 | 95% Confidence Interval 278 to 365 | days | |
| Overall Response Rate | Bortezomib + Rituximab | 199 | participants | ||
| Overall Response Rate | Rituximab | 160 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bortezomib + Rituximab | 336 | |
| Overall Study | STARTED | Rituximab | 340 | |
| Overall Study | COMPLETED | Bortezomib + Rituximab | 237 | |
| Overall Study | COMPLETED | Rituximab | 245 | |
| Overall Study | NOT COMPLETED | Bortezomib + Rituximab | 99 | |
| Overall Study | NOT COMPLETED | Rituximab | 95 |
Source ClinicalTrials.gov
Adverse events252
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 | Thrombocytopenia | Blood and lymphatic system disorders | Bortezomib + Rituximab | 32 | 334 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab | 13 | 339 | |
| other | Chills | General disorders | Bortezomib + Rituximab | 28 | 334 | |
| other | Chills | General disorders | Rituximab | 17 | 339 | |
| other | Fatigue | General disorders | Bortezomib + Rituximab | 75 | 334 | |
| other | Fatigue | General disorders | Rituximab | 27 | 339 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Bortezomib + Rituximab | 37 | 334 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Rituximab | 25 | 339 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Bortezomib + Rituximab | 46 | 334 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Rituximab | 15 | 339 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib + Rituximab | ||
| Total, all-cause mortality | Rituximab | ||
| Total, other adverse events | Bortezomib + Rituximab | 288 | 334 |
| Total, other adverse events | Rituximab | 232 | 339 |
| Total, serious adverse events | Bortezomib + Rituximab | 59 | 334 |
| Total, serious adverse events | Rituximab | 37 | 339 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bortezomib + Rituximab vs Rituximab: Overall Response Rate | Trial comparisons |
| Bortezomib + Rituximab vs Rituximab: serious adverse events | Trial comparisons |
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/NCT00312845
GET https://conductscience.org/api/trials/v1/NCT00312845/events?page=2