Trial · NCT00651937
Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
NCT00651937, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden. Trials, record NCT00651937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00651937
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
- NCT number
- NCT00651937
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Multiple Myeloma, Primary Amyloidosis
- Interventions
- Melphalan, Stem Cell Infusion, Questionnaires, Granulocyte-colony stimulating factor (G-CSF), Apheresis
- First posted
- 2008-04-03
- Last updated
- 2020-01-14
- Results first posted
- 2020-01-14
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Symptom Severity Burden as Measured by MDASI Scores | The first 7 days post-transplant. | MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive symptoms on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10). |
| Primary | Mean Symptom Severity Burden as Measured by MDASI Scores | 28 day course of ASCT | MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Symptom Severity Burden as Measured by MDASI Scores | The first 7 days post-transplant. | Intention to treat analysis, all treated participants. One participant in High Dose group did not complete adequate number of MDASI's for analysis. | score on a scale | MEAN |
| PRIMARY | Mean Symptom Severity Burden as Measured by MDASI Scores | 28 day course of ASCT | Intention to treat analysis, all treated participants. One participant in High Dose group did not complete adequate number of MDSAIs for analysis. | score on a scale | MEAN |
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 |
|---|---|---|---|---|---|
| Mean Symptom Severity Burden as Measured by MDASI Scores | Standard Dose Stem Cell Group | 4.27 | Standard Deviation 2.372 | score on a scale | |
| Mean Symptom Severity Burden as Measured by MDASI Scores | High Dose Stem Cell Group | 4.26 | Standard Deviation 2.264 | score on a scale | |
| Mean Symptom Severity Burden as Measured by MDASI Scores | Standard Dose Stem Cell Group | 228.4 | Standard Deviation 191.0 | score on a scale | |
| Mean Symptom Severity Burden as Measured by MDASI Scores | High Dose Stem Cell Group | 223.0 | Standard Deviation 94.0 | score on a scale |
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 | Standard Dose Stem Cell Group | 39 | |
| Overall Study | STARTED | High Dose Stem Cell Group | 41 | |
| Overall Study | COMPLETED | Standard Dose Stem Cell Group | 35 | |
| Overall Study | COMPLETED | High Dose Stem Cell Group | 40 | |
| Overall Study | NOT COMPLETED | Standard Dose Stem Cell Group | 4 | |
| Overall Study | NOT COMPLETED | High Dose Stem Cell Group | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | Graft Failure | Blood and lymphatic system disorders | Standard Dose Stem Cell Group | 1 | 35 | 1 |
| other | Graft Failure | Blood and lymphatic system disorders | High Dose Stem Cell Group | 0 | 40 | 0 |
| serious | Graft Failure | Immune system disorders | Standard Dose Stem Cell Group | 1 | 35 | 1 |
| serious | Graft Failure | Immune system disorders | High Dose Stem Cell Group | 0 | 40 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Dose Stem Cell Group | 0 | 35 |
| Total, all-cause mortality | High Dose Stem Cell Group | 0 | 40 |
| Total, other adverse events | Standard Dose Stem Cell Group | 1 | 35 |
| Total, other adverse events | High Dose Stem Cell Group | 0 | 40 |
| Total, serious adverse events | Standard Dose Stem Cell Group | 1 | 35 |
| Total, serious adverse events | High Dose Stem Cell Group | 0 | 40 |
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 |
|---|---|
| Standard Dose Stem Cell Group vs High Dose Stem Cell Group: deaths from any cause | Trial comparisons |
| Standard Dose Stem Cell Group vs High Dose Stem Cell Group: 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/NCT00651937
GET https://conductscience.org/api/trials/v1/NCT00651937/registered