Trial · NCT02489500
Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
NCT02489500, Phase 3, Terminated, Boston Medical Center; results first posted 2018-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib. Trials, record NCT02489500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02489500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
- NCT number
- NCT02489500
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- AL Amyloidosis
- Interventions
- Bortezomib, Melphalan, Neupogen, Stem Cell Collection, Stem cell infusion
- First posted
- 2015-07-03
- Last updated
- 2018-09-10
- Results first posted
- 2018-08-06
- Limitations and caveats
- Early termination after enrollment held for toxicity evaluation; then closed due to competing trial.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hematologic Response | 6 months | Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains |
| Secondary | Toxicities | 100 days | Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
| Secondary | Overall Survival | 5 years | duration of overall survival measured in days |
| Secondary | Number of Participants With Organ Response | 5 years | analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Hematologic Response | 6 months | Two participants were not evaluable as they expired and did not have a post-treatment response evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxicities | 100 days | events per participant | MEAN | |
| SECONDARY | Overall Survival | 5 years | The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed. | days | NUMBER |
| SECONDARY | Number of Participants With Organ Response | 5 years | Due to early termination, organ response data was not collected. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hematologic Response | Melphalan | 0 | Participants | ||
| Number of Participants With Hematologic Response | Melphalan + Bortezomib | 0 | Participants | ||
| Toxicities | Melphalan | 8.5 | Full Range 4 to 13 | events per participant | |
| Toxicities | Melphalan + Bortezomib | 15 | Full Range 15 to 15 | events per participant | |
| Overall Survival | Melphalan | 43 | days | ||
| Overall Survival | Melphalan + Bortezomib | 29 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melphalan | 2 | |
| Overall Study | STARTED | Melphalan + Bortezomib | 1 | |
| Overall Study | COMPLETED | Melphalan | 1 | |
| Overall Study | COMPLETED | Melphalan + Bortezomib | 0 | |
| Overall Study | NOT COMPLETED | Melphalan | 1 | |
| Overall Study | NOT COMPLETED | Melphalan + Bortezomib | 1 |
Source ClinicalTrials.gov
Adverse events162
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 | tachycardia | Cardiac disorders | Melphalan | 2 | 2 | 2 |
| other | tachycardia | Cardiac disorders | Melphalan + Bortezomib | 0 | 1 | 0 |
| other | sinus tachycardia | Cardiac disorders | Melphalan | 0 | 2 | 0 |
| other | sinus tachycardia | Cardiac disorders | Melphalan + Bortezomib | 1 | 1 | 1 |
| other | photophobia | Ear and labyrinth disorders | Melphalan | 1 | 2 | 1 |
| other | photophobia | Ear and labyrinth disorders | Melphalan + Bortezomib | 0 | 1 | 0 |
| other | syndrome of inappropriate antidiuretic hormone secretion (SIADH) | Endocrine disorders | Melphalan | 1 | 2 | 1 |
| other | syndrome of inappropriate antidiuretic hormone secretion (SIADH) | Endocrine disorders | Melphalan + Bortezomib | 0 | 1 | 0 |
| other | adrenal insufficience | Endocrine disorders | Melphalan | 1 | 2 | 1 |
| other | adrenal insufficience | Endocrine disorders | Melphalan + Bortezomib | 0 | 1 | 0 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melphalan | 1 | 2 |
| Total, all-cause mortality | Melphalan + Bortezomib | 1 | 1 |
| Total, other adverse events | Melphalan | 2 | 2 |
| Total, other adverse events | Melphalan + Bortezomib | 1 | 1 |
| Total, serious adverse events | Melphalan | 2 | 2 |
| Total, serious adverse events | Melphalan + Bortezomib | 1 | 1 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Melphalan vs Melphalan + Bortezomib: deaths from any cause | Trial comparisons |
| Melphalan vs Melphalan + Bortezomib: serious adverse events | Trial comparisons |
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/NCT02489500
GET https://conductscience.org/api/trials/v1/NCT02489500/events?page=2