Trial · NCT00715208
Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
NCT00715208, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2013-04-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma. Trials, record NCT00715208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00715208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
- NCT number
- NCT00715208
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Relapsed Follicular Lymphoma
- Interventions
- rituximab, cyclophosphamide, doxorubicin, VELCADE, prednisone
- First posted
- 2008-07-15
- Last updated
- 2013-04-29
- Results first posted
- 2013-04-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Complete Response (CR) | 30 weeks | Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria. |
| Secondary | Number of Participants With Overall Response (OR) | 30 weeks | OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria. CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET. |
| Secondary | Percentage of Participants With Progression-free Survival (PFS) at 1 Year | Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD | PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better). |
| Secondary | Duration of Response | 2 years | Time (in months) from the first documentation of a response (CR or partial response \[PR\]) to the date of first documentation of progressive disease or relapse from complete response. CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria. |
| Secondary | Number of Patients Who Experienced at Least One Serious Adverse Event | From completion of informed consent through 30 days after the last dose of study drug |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Complete Response (CR) | 30 weeks | Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death. | participants | NUMBER |
| SECONDARY | Number of Participants With Overall Response (OR) | 30 weeks | Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Progression-free Survival (PFS) at 1 Year | Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD | Safety population: Treated | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | 2 years | Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders) | Months | MEDIAN |
| SECONDARY | Number of Patients Who Experienced at Least One Serious Adverse Event | From completion of informed consent through 30 days after the last dose of study drug | Safety Population: Treated patients | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Complete Response (CR) | VELCADE R-CAP | 1 | 0 to 36 | participants | |
| Number of Patients With Complete Response (CR) | VELCADE R-CP | 13 | participants | ||
| Number of Participants With Overall Response (OR) | VELCADE R-CAP | 6 | participants | ||
| Number of Participants With Overall Response (OR) | VELCADE R-CP | 37 | participants | ||
| Percentage of Participants With Progression-free Survival (PFS) at 1 Year | VELCADE R-CAP | 67 | 9.4 to ? | percentage of participants | |
| Percentage of Participants With Progression-free Survival (PFS) at 1 Year | VELCADE R-CP | 63 | 11.2 to ? | percentage of participants | |
| Duration of Response | VELCADE R-CP | 21.9 | 95% Confidence Interval 9.4 to NA | Months | |
| Number of Patients Who Experienced at Least One Serious Adverse Event | VELCADE R-CAP | 2 | participants | ||
| Number of Patients Who Experienced at Least One Serious Adverse Event | VELCADE R-CP | 12 | 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 | VELCADE R-CAP | 7 | |
| Overall Study | STARTED | VELCADE R-CP | 48 | |
| Overall Study | COMPLETED | VELCADE R-CAP | 6 | |
| Overall Study | COMPLETED | VELCADE R-CP | 39 | |
| Overall Study | NOT COMPLETED | VELCADE R-CAP | 1 | |
| Overall Study | NOT COMPLETED | VELCADE R-CP | 9 |
Source ClinicalTrials.gov
Adverse events214
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 | Diarrhoea | Gastrointestinal disorders | VELCADE R-CAP | 2 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | VELCADE R-CP | 24 | 48 | |
| other | Nausea | Gastrointestinal disorders | VELCADE R-CAP | 3 | 7 | |
| other | Nausea | Gastrointestinal disorders | VELCADE R-CP | 21 | 48 | |
| other | Vomiting NOS | Gastrointestinal disorders | VELCADE R-CAP | 0 | 7 | |
| other | Vomiting NOS | Gastrointestinal disorders | VELCADE R-CP | 12 | 48 | |
| other | Constipation | Gastrointestinal disorders | VELCADE R-CAP | 3 | 7 | |
| other | Constipation | Gastrointestinal disorders | VELCADE R-CP | 10 | 48 | |
| other | Stomatitis | Gastrointestinal disorders | VELCADE R-CAP | 3 | 7 | |
| other | Stomatitis | Gastrointestinal disorders | VELCADE R-CP | 2 | 48 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VELCADE R-CAP | ||
| Total, all-cause mortality | VELCADE R-CP | ||
| Total, other adverse events | VELCADE R-CAP | 7 | 7 |
| Total, other adverse events | VELCADE R-CP | 47 | 48 |
| Total, serious adverse events | VELCADE R-CAP | 2 | 7 |
| Total, serious adverse events | VELCADE R-CP | 12 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25039282 | DERIVED |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| VELCADE R-CAP vs VELCADE R-CP: Number of Participants With Overall Response (OR) | Trial comparisons |
| VELCADE R-CAP vs VELCADE R-CP: Number of Patients With Complete Response (CR) | Trial comparisons |
| VELCADE R-CAP vs VELCADE R-CP: Number of Patients Who Experienced at Least One Serious Adverse Event | Trial comparisons |
| VELCADE R-CAP vs VELCADE R-CP: 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/NCT00715208
GET https://conductscience.org/api/trials/v1/NCT00715208/events?page=2