Trial · NCT00507416
Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
NCT00507416, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2014-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone. Trials, record NCT00507416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00507416
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
- NCT number
- NCT00507416
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 502 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Multiple Myeloma
- Interventions
- Bortezomib, Dexamethasone, Melphalan, Prednisone, Thalidomide
- First posted
- 2007-07-26
- Last updated
- 2014-05-01
- Results first posted
- 2014-05-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization until disease progression. Median follow-up time was 43 months. | PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria. Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease |
| Secondary | Percentage of Participants With an Overall Response | Response assessed every other cycle for up to 13 cycles (49 weeks). | Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria. CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours (h). PR requires 1 of the following: * ≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \<200 mg/24 h, or * If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or * If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%. If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required. |
| Secondary | Percentage of Participants With a Complete Response | Response assessed every other cycle, for up to 13 cycles (49 weeks). | Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria. |
| Secondary | Percentage of Participants With a Complete Response or a Very Good Partial Response | Response assessed every other cycle for up to 13 cycles (49 weeks). | Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours. Response was assessed by the Investigator using the IMWG uniform response criteria. |
| Secondary | Duration of Response | From first documented response until disease progression. Median follow-up time was 43 months. | Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response. |
| Secondary | Overall Survival | From randomization until death. Median follow-up time was 43 months. | Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact. |
| Secondary | Time to Alternative Therapy | From randomization until alternative therapy. Median follow-up time was 43 months. | Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact. |
| Secondary | Change From Baseline in EORTC QLQ-C30 - Global Health Status | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13 | The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From randomization until disease progression. Median follow-up time was 43 months. | Intent-to-treat (all randomized participants) | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Overall Response | Response assessed every other cycle for up to 13 cycles (49 weeks). | Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Complete Response | Response assessed every other cycle, for up to 13 cycles (49 weeks). | Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Complete Response or a Very Good Partial Response | Response assessed every other cycle for up to 13 cycles (49 weeks). | Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From first documented response until disease progression. Median follow-up time was 43 months. | Participants with an overall response | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until death. Median follow-up time was 43 months. | Intent to treat | months | MEDIAN |
| SECONDARY | Time to Alternative Therapy | From randomization until alternative therapy. Median follow-up time was 43 months. | Intent to Treat | months | MEDIAN |
| SECONDARY | Change From Baseline in EORTC QLQ-C30 - Global Health Status | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13 | Intent-to-treat population with available data at each time point (indicated by n). | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Bortezomib and Dexamethasone | 14.7 | 95% Confidence Interval 12.0 to 18.6 | months | |
| Progression Free Survival (PFS) | Bortezomib, Thalidomide, and Dexamethasone | 15.4 | 95% Confidence Interval 12.6 to 24.2 | months | |
| Progression Free Survival (PFS) | Bortezomib, Melphalan and Prednisone | 17.3 | 95% Confidence Interval 14.8 to 20.3 | months | |
| Percentage of Participants With an Overall Response | Bortezomib and Dexamethasone | 73 | percentage of participants | ||
| Percentage of Participants With an Overall Response | Bortezomib, Thalidomide, and Dexamethasone | 80 | percentage of participants | ||
| Percentage of Participants With an Overall Response | Bortezomib, Melphalan and Prednisone | 70 | percentage of participants | ||
| Percentage of Participants With a Complete Response | Bortezomib and Dexamethasone | 3 | percentage of participants | ||
| Percentage of Participants With a Complete Response | Bortezomib, Thalidomide, and Dexamethasone | 4 | percentage of participants | ||
| Percentage of Participants With a Complete Response | Bortezomib, Melphalan and Prednisone | 4 | percentage of participants | ||
| Percentage of Participants With a Complete Response or a Very Good Partial Response | Bortezomib and Dexamethasone | 37 | percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bortezomib and Dexamethasone | 168 | |
| Overall Study | STARTED | Bortezomib, Thalidomide, and Dexamethasone | 167 | |
| Overall Study | STARTED | Bortezomib, Melphalan and Prednisone | 167 | |
| Overall Study | Treated (Safety Population) | Bortezomib and Dexamethasone | 165 | |
| Overall Study | Treated (Safety Population) | Bortezomib, Thalidomide, and Dexamethasone | 158 | |
| Overall Study | Treated (Safety Population) | Bortezomib, Melphalan and Prednisone | 163 | |
| Overall Study | Completed 8 Treatment Cycles | Bortezomib and Dexamethasone | 82 | |
| Overall Study | Completed 8 Treatment Cycles | Bortezomib, Thalidomide, and Dexamethasone | 60 | |
| Overall Study | Completed 8 Treatment Cycles | Bortezomib, Melphalan and Prednisone | 69 | |
| Overall Study | COMPLETED | Bortezomib and Dexamethasone | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,269
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 | Weight decreased | Investigations | Bortezomib and Dexamethasone | 4 | 165 | |
| other | Weight decreased | Investigations | Bortezomib, Thalidomide, and Dexamethasone | 2 | 158 | |
| other | Weight decreased | Investigations | Bortezomib, Melphalan and Prednisone | 6 | 163 | |
| other | Platelet count decreased | Investigations | Bortezomib and Dexamethasone | 3 | 165 | |
| other | Platelet count decreased | Investigations | Bortezomib, Thalidomide, and Dexamethasone | 1 | 158 | |
| other | Platelet count decreased | Investigations | Bortezomib, Melphalan and Prednisone | 7 | 163 | |
| other | Blood sodium decreased | Investigations | Bortezomib and Dexamethasone | 3 | 165 | |
| other | Blood sodium decreased | Investigations | Bortezomib, Thalidomide, and Dexamethasone | 3 | 158 | |
| other | Blood sodium decreased | Investigations | Bortezomib, Melphalan and Prednisone | 3 | 163 | |
| other | Blood uric acid increased | Investigations | Bortezomib and Dexamethasone | 2 | 165 |
1 to 10 of 1,269Source ClinicalTrials.gov
See all 1,269 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib and Dexamethasone | ||
| Total, all-cause mortality | Bortezomib, Thalidomide, and Dexamethasone | ||
| Total, all-cause mortality | Bortezomib, Melphalan and Prednisone | ||
| Total, other adverse events | Bortezomib and Dexamethasone | 57 | 165 |
| Total, other adverse events | Bortezomib, Thalidomide, and Dexamethasone | 68 | 158 |
| Total, other adverse events | Bortezomib, Melphalan and Prednisone | 68 | 163 |
| Total, serious adverse events | Bortezomib and Dexamethasone | 88 | 165 |
| Total, serious adverse events | Bortezomib, Thalidomide, and Dexamethasone | 92 | 158 |
| Total, serious adverse events | Bortezomib, Melphalan and Prednisone | 83 | 163 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26056177 | 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 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/NCT00507416
GET https://conductscience.org/api/trials/v1/NCT00507416/results?page=2