Trial · NCT00790647
Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
NCT00790647, Phase 2, Completed, Boston Medical Center; results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis. Trials, record NCT00790647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
- NCT number
- NCT00790647
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Multiple Myeloma
- Interventions
- filgrastim, bortezomib, melphalan, Stem Cell Infusion
- First posted
- 2008-11-13
- Last updated
- 2017-02-06
- Results first posted
- 2017-02-06
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 | one year | complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy \<5% plasma cells with no clonal predominance of kappa or lambda isotype. Partial response: any one of the following 1. For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. 2. For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more. 3. For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume). |
| Secondary | Number of Participants Surviving at 100 Days From Transplant | 100 Days from transplant date | |
| Secondary | Number of Participants Surviving at 1 Year | one year from transplant | |
| Secondary | Number of Participants Surviving at 2 Years | 2 years from transplant |
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 | one year | participants | NUMBER | |
| SECONDARY | Number of Participants Surviving at 100 Days From Transplant | 100 Days from transplant date | participants | NUMBER | |
| SECONDARY | Number of Participants Surviving at 1 Year | one year from transplant | participants | NUMBER | |
| SECONDARY | Number of Participants Surviving at 2 Years | 2 years from transplant | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
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 | Stem Cell Transplant With Bortezomib and Melphalan | 6 | participants | ||
| Number of Participants Surviving at 100 Days From Transplant | Stem Cell Transplant With Bortezomib and Melphalan | 9 | participants | ||
| Number of Participants Surviving at 1 Year | Stem Cell Transplantation With Bortezomib and Melphalan | 9 | participants | ||
| Number of Participants Surviving at 2 Years | Stem Cell Transplant With Bortezomib and Melphalan | 9 | Participants |
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 | SCT With Bortezomib and Melphalan | 10 | |
| Overall Study | COMPLETED | SCT With Bortezomib and Melphalan | 9 | |
| Overall Study | NOT COMPLETED | SCT With Bortezomib and Melphalan | 1 |
Source ClinicalTrials.gov
Adverse events28
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 | nausea | Gastrointestinal disorders | SCT With Bortezomib and Melphalan | 3 | 9 | 5 |
| other | diarrhea | Gastrointestinal disorders | SCT With Bortezomib and Melphalan | 4 | 9 | 6 |
| other | fatigue | General disorders | SCT With Bortezomib and Melphalan | 7 | 9 | 7 |
| other | creatinine increased | Investigations | SCT With Bortezomib and Melphalan | 1 | 9 | 1 |
| other | deconditioning | General disorders | SCT With Bortezomib and Melphalan | 6 | 9 | 6 |
| other | increased alkylase phosphate | Investigations | SCT With Bortezomib and Melphalan | 8 | 9 | 8 |
| other | hypocalcemia | Investigations | SCT With Bortezomib and Melphalan | 3 | 9 | 4 |
| other | hypoalbuminemia | Investigations | SCT With Bortezomib and Melphalan | 1 | 9 | 1 |
| other | hiccups | General disorders | SCT With Bortezomib and Melphalan | 4 | 9 | 5 |
| other | dyspnea | Respiratory, thoracic and mediastinal disorders | SCT With Bortezomib and Melphalan | 2 | 9 | 2 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SCT With Bortezomib and Melphalan | ||
| Total, other adverse events | SCT With Bortezomib and Melphalan | 9 | 9 |
| Total, serious adverse events | SCT With Bortezomib and Melphalan | 9 | 9 |
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/NCT00790647
GET https://conductscience.org/api/trials/v1/NCT00790647/events?page=2