Trial · NCT00520767
Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
NCT00520767, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2015-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease. Trials, record NCT00520767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00520767
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
- NCT number
- NCT00520767
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Primary Systemic Amyloidosis, Light Chain Deposition Disease
- Interventions
- bortezomib, dexamethasone, melphalan, microarray analysis, flow cytometry, laboratory biomarker analysis, quality-of-life assessment
- First posted
- 2007-08-27
- Last updated
- 2023-12-22
- Results first posted
- 2015-03-30
- Limitations and caveats
Mix of previously treated \& newly diagnosed pts (populations which may have different prognoses), plus the relatively small trial size limit conclusions one can draw re: relative efficacy of MDV (vs CyBorD or Mel-Dex, for example)
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Hematologic Response | Up to 12 months | |
| Secondary | Overall Survival | time from day of registration until 72 months. | time from day of registration until day of death. |
| Secondary | Time to Treatment Failure (TTF) | start of treatment until 72 months | Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause. |
| Secondary | Organ Response Rate (OrR) | Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study. | |
| Secondary | Overall Hematologic Response Rate (OHR) | Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study. |
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 | Complete Hematologic Response | Up to 12 months | Individuals evaluable for response | participants | NUMBER |
| SECONDARY | Overall Survival | time from day of registration until 72 months. | month | MEDIAN | |
| SECONDARY | Time to Treatment Failure (TTF) | start of treatment until 72 months | month | MEDIAN | |
| SECONDARY | Organ Response Rate (OrR) | Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study. | Not collected not analyzed. | ||
| SECONDARY | Overall Hematologic Response Rate (OHR) | Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study. | Not collected not analyzed. |
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 |
|---|---|---|---|---|---|
| Complete Hematologic Response | Melphalan, Dexamethasone, Bortezomib, | 16 | participants | ||
| Overall Survival | Melphalan, Dexamethasone, Bortezomib, | 31.1 | 95% Confidence Interval 22.1 to 45.5 | month | |
| Time to Treatment Failure (TTF) | Melphalan, Dexamethasone, Bortezomib, | 18.1 | 95% Confidence Interval 10.8 to 34.4 | month |
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 | Melphalan, Dexamethasone, Bortezomib, | 35 | |
| Overall Study | COMPLETED | Melphalan, Dexamethasone, Bortezomib, | 33 | |
| Overall Study | NOT COMPLETED | Melphalan, Dexamethasone, Bortezomib, | 2 |
Source ClinicalTrials.gov
Adverse events26
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 | Constipation | Gastrointestinal disorders | Melphalan, Dexamethasone, Bortezomib, | 2 | 35 | 2 |
| other | Hemoglobin | Blood and lymphatic system disorders | Melphalan, Dexamethasone, Bortezomib, | 2 | 35 | 2 |
| serious | Death | General disorders | Melphalan, Dexamethasone, Bortezomib, | 2 | 35 | 2 |
| serious | Infection with Normal ANC-Lung (pneumonia) | Infections and infestations | Melphalan, Dexamethasone, Bortezomib, | 2 | 35 | 2 |
| serious | Pain-chest wall | General disorders | Melphalan, Dexamethasone, Bortezomib, | 1 | 35 | 1 |
| serious | Congestive Heart Failure | Cardiac disorders | Melphalan, Dexamethasone, Bortezomib, | 1 | 35 | 1 |
| serious | Dehydration | Gastrointestinal disorders | Melphalan, Dexamethasone, Bortezomib, | 2 | 35 | 2 |
| serious | Hyperglycemia | Metabolism and nutrition disorders | Melphalan, Dexamethasone, Bortezomib, | 1 | 35 | 1 |
| serious | Hyponatremia | Metabolism and nutrition disorders | Melphalan, Dexamethasone, Bortezomib, | 1 | 35 | 1 |
| serious | Mental Status Change | Psychiatric disorders | Melphalan, Dexamethasone, Bortezomib, | 2 | 35 | 2 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melphalan, Dexamethasone, Bortezomib, | ||
| Total, other adverse events | Melphalan, Dexamethasone, Bortezomib, | 3 | 35 |
| Total, serious adverse events | Melphalan, Dexamethasone, Bortezomib, | 12 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00520767
GET https://conductscience.org/api/trials/v1/NCT00520767/events?page=2