Trial · NCT00469209
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
NCT00469209, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2011-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients. Trials, record NCT00469209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00469209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
- NCT number
- NCT00469209
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Myeloma
- Interventions
- Trisenox (Arsenic Trioxide), Velcade (Bortezomib), Melphalan, Vitamin C (Ascorbic Acid)
- First posted
- 2007-05-04
- Last updated
- 2020-09-24
- Results first posted
- 2011-04-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Reaching Complete Response (CR) | Baseline through Day 180, with assessments at Day 90 and Day 180 | Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease. |
| Secondary | Time to Toxicity | Baseline to event occurence (assessed weekly first 30 days) | The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3. |
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 | Number of Patients Reaching Complete Response (CR) | Baseline through Day 180, with assessments at Day 90 and Day 180 | Analysis was per protocol. | participants | NUMBER |
| SECONDARY | Time to Toxicity | Baseline to event occurence (assessed weekly first 30 days) |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Reaching Complete Response (CR) | No Bortezomib | 4 | participants | ||
| Number of Patients Reaching Complete Response (CR) | Bortezomib 1.0 mg/m^2 | 1 | participants | ||
| Number of Patients Reaching Complete Response (CR) | Bortezomib 1.5 mg/m^2 | 4 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | No Bortezomib | 20 | |
| Overall Study | STARTED | Bortezomib 1.0 mg/m^2 | 20 | |
| Overall Study | STARTED | Bortezomib 1.5 mg/m^2 | 20 | |
| Overall Study | COMPLETED | No Bortezomib | 19 | |
| Overall Study | COMPLETED | Bortezomib 1.0 mg/m^2 | 20 | |
| Overall Study | COMPLETED | Bortezomib 1.5 mg/m^2 | 19 | |
| Overall Study | NOT COMPLETED | No Bortezomib | 1 | |
| Overall Study | NOT COMPLETED | Bortezomib 1.0 mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | Bortezomib 1.5 mg/m^2 | 1 |
Source ClinicalTrials.gov
Adverse events42
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 | mucositis | Gastrointestinal disorders | No Bortezomib | 3 | 20 | 3 |
| other | mucositis | Gastrointestinal disorders | Bortezomib 1.0 mg/m^2 | 3 | 20 | 3 |
| other | mucositis | Gastrointestinal disorders | Bortezomib 1.5 mg/m^2 | 1 | 20 | 1 |
| other | dyspnea | Respiratory, thoracic and mediastinal disorders | No Bortezomib | 1 | 20 | 1 |
| other | dyspnea | Respiratory, thoracic and mediastinal disorders | Bortezomib 1.0 mg/m^2 | 0 | 20 | 0 |
| other | dyspnea | Respiratory, thoracic and mediastinal disorders | Bortezomib 1.5 mg/m^2 | 0 | 20 | 0 |
| other | diarrhea | Gastrointestinal disorders | No Bortezomib | 0 | 20 | 0 |
| other | diarrhea | Gastrointestinal disorders | Bortezomib 1.0 mg/m^2 | 1 | 20 | 1 |
| other | diarrhea | Gastrointestinal disorders | Bortezomib 1.5 mg/m^2 | 0 | 20 | 0 |
| other | hydronephrosis | Renal and urinary disorders | No Bortezomib | 0 | 20 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | No Bortezomib | ||
| Total, all-cause mortality | Bortezomib 1.0 mg/m^2 | ||
| Total, all-cause mortality | Bortezomib 1.5 mg/m^2 | ||
| Total, other adverse events | No Bortezomib | 4 | 20 |
| Total, other adverse events | Bortezomib 1.0 mg/m^2 | 5 | 20 |
| Total, other adverse events | Bortezomib 1.5 mg/m^2 | 5 | 20 |
| Total, serious adverse events | No Bortezomib | 3 | 20 |
| Total, serious adverse events | Bortezomib 1.0 mg/m^2 | 2 | 20 |
| Total, serious adverse events | Bortezomib 1.5 mg/m^2 | 2 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00469209
GET https://conductscience.org/api/trials/v1/NCT00469209/events?page=2