Trial · NCT00983346
Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients
NCT00983346, Phase 2, Terminated, University of Utah; results first posted 2015-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients. Trials, record NCT00983346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00983346
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients
- NCT number
- NCT00983346
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Cancer, Myeloma, Multiple Myeloma
- Interventions
- Bortezomib
- First posted
- 2009-09-24
- Last updated
- 2016-07-11
- Results first posted
- 2015-11-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Baseline and 6 weeks | The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks. |
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 | Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Baseline and 6 weeks | Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study | Percentage of Baseline Value | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 1 | 178 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 3 | 105 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 4 | 105 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 6 | 99 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 7 | 95 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 8 | 119 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 10 | 128 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 11 | 84 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 13 | 125 | Percentage of Baseline Value | |
| Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma. | Arm 1 Bortezomib | % Base Line Patient 14 | 120 | Percentage of Baseline Value |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm -1 Bortezomib | 17 | |
| Overall Study | COMPLETED | Arm -1 Bortezomib | 17 | |
| Overall Study | NOT COMPLETED | Arm -1 Bortezomib | 0 |
Source ClinicalTrials.gov
Adverse events72
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 | abdomen pain | Gastrointestinal disorders | Arm 1 Bortezomib | 2 | 17 | 2 |
| other | allergic reaction | Immune system disorders | Arm 1 Bortezomib | 1 | 17 | 1 |
| other | altered mental status | Nervous system disorders | Arm 1 Bortezomib | 1 | 17 | 2 |
| other | anxiety | Nervous system disorders | Arm 1 Bortezomib | 2 | 17 | 2 |
| other | back pain | Musculoskeletal and connective tissue disorders | Arm 1 Bortezomib | 1 | 17 | 3 |
| other | blurred vision | Eye disorders | Arm 1 Bortezomib | 1 | 17 | 1 |
| other | bruising | Skin and subcutaneous tissue disorders | Arm 1 Bortezomib | 3 | 17 | 3 |
| other | Candida albicans | Infections and infestations | Arm 1 Bortezomib | 1 | 17 | 1 |
| other | cardiomegaly | Cardiac disorders | Arm 1 Bortezomib | 1 | 17 | 1 |
| other | Chest pain | Musculoskeletal and connective tissue disorders | Arm 1 Bortezomib | 3 | 17 | 3 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 Bortezomib | ||
| Total, other adverse events | Arm 1 Bortezomib | 17 | 17 |
| Total, serious adverse events | Arm 1 Bortezomib | 2 | 17 |
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/NCT00983346
GET https://conductscience.org/api/trials/v1/NCT00983346/events?page=2