Trial · NCT00307086
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
NCT00307086, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2013-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants. Trials, record NCT00307086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00307086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
- NCT number
- NCT00307086
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Interventions
- Bortezomib, Melphalan, PBSCT
- First posted
- 2006-03-27
- Last updated
- 2017-03-06
- Results first posted
- 2013-10-24
- Limitations and caveats
per protocol subjects are followed for 2 years post transplant; however, subjects are followed on our long-term follow-up protocol(MCC12567/IRB6101) to assess overall and disease free survival. additional data available at time manuscript was written
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 40 months post transplant | Median overall survival after first peripheral blood stem cell transplant (PBSCT). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 40 months post transplant | All evaluable participants | months | MEDIAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Autologous PBSCT | 40 | 95% Confidence Interval 32 to 40 | months |
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 | Autologous PBSCT | 30 | |
| Overall Study | COMPLETED | Autologous PBSCT | 25 | |
| Overall Study | NOT COMPLETED | Autologous PBSCT | 5 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Febrile Neutropenia | Infections and infestations | Autologous PBSCT | 13 | 25 | |
| serious | Bacteremia | Infections and infestations | Autologous PBSCT | 6 | 25 | |
| serious | Hypokalaemia | Metabolism and nutrition disorders | Autologous PBSCT | 7 | 25 | |
| serious | Mucositis | Gastrointestinal disorders | Autologous PBSCT | 4 | 25 | |
| serious | Hypophosphatemia | Metabolism and nutrition disorders | Autologous PBSCT | 3 | 25 | |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Autologous PBSCT | 2 | 25 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Autologous PBSCT | ||
| Total, other adverse events | Autologous PBSCT | 0 | 25 |
| Total, serious adverse events | Autologous PBSCT | 25 | 25 |
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/NCT00307086
GET https://conductscience.org/api/trials/v1/NCT00307086/registered