Trial · NCT00006184
Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
NCT00006184, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-01-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma. Trials, record NCT00006184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00006184
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
- NCT number
- NCT00006184
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Multiple Myeloma
- Interventions
Myeloma Immunoglobulin Idiotype Vaccine, Bortezomib, Cyclophosphamide, Cyclosporine, Doxorubicin hydrochloride, Etoposide, Fludarabine phosphate, Prednisone, Vincristine Sulfate, Methotrexate, GMCSF (granulocyte macrophage colony stimulating factor), GCSF (granulocyte colony stimulating factor)
- First posted
- 2000-08-24
- Last updated
- 2017-10-20
- Results first posted
- 2013-01-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune Response | 105 days | Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) \> 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. |
| Primary | Number of Participants With Adverse Events | 9 years | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. |
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 | Immune Response | 105 days | This outcome measure was only pre-specified to be measured in the recipient Arm/Group. | Particpants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events | 9 years | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Immune Response | Recipient - Chemotherapy Group | 7 | Particpants | ||
| Number of Participants With Adverse Events | Recipient - Chemotherapy Group | 10 | Participants | ||
| Number of Participants With Adverse Events | Donor - Vaccination Generation Group | 10 | Participants |
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 | Recipient - Chemotherapy Group | 10 | |
| Overall Study | STARTED | Donor - Vaccination Generation Group | 10 | |
| Overall Study | COMPLETED | Recipient - Chemotherapy Group | 9 | |
| Overall Study | COMPLETED | Donor - Vaccination Generation Group | 10 | |
| Overall Study | NOT COMPLETED | Recipient - Chemotherapy Group | 1 | |
| Overall Study | NOT COMPLETED | Donor - Vaccination Generation Group | 0 |
Source ClinicalTrials.gov
Adverse events272
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 | Abdominal pain or cramping | Gastrointestinal disorders | Recipient - Chemotherapy Group | 2 | 10 | 3 |
| other | Abdominal pain or cramping | Gastrointestinal disorders | Donor - Vaccination Generation Group | 3 | 10 | 3 |
| other | Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | Recipient - Chemotherapy Group | 1 | 10 | 1 |
| other | Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | Donor - Vaccination Generation Group | 0 | 10 | 0 |
| other | Alkaline phosphatase | Investigations | Recipient - Chemotherapy Group | 3 | 10 | 6 |
| other | Alkaline phosphatase | Investigations | Donor - Vaccination Generation Group | 2 | 10 | 2 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Recipient - Chemotherapy Group | 1 | 10 | 1 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Donor - Vaccination Generation Group | 0 | 10 | 0 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Recipient - Chemotherapy Group | 2 | 10 | 4 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Donor - Vaccination Generation Group | 1 | 10 | 1 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recipient - Chemotherapy Group | 0 | 10 |
| Total, all-cause mortality | Donor - Vaccination Generation Group | 0 | 10 |
| Total, other adverse events | Recipient - Chemotherapy Group | 10 | 10 |
| Total, other adverse events | Donor - Vaccination Generation Group | 10 | 10 |
| Total, serious adverse events | Recipient - Chemotherapy Group | 10 | 10 |
| Total, serious adverse events | Donor - Vaccination Generation Group | 0 | 10 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Recipient - Chemotherapy Group vs Donor - Vaccination Generation Group: Number of Participants With Adverse Events | Trial comparisons |
| Recipient - Chemotherapy Group vs Donor - Vaccination Generation Group: deaths from any cause | Trial comparisons |
| Recipient - Chemotherapy Group vs Donor - Vaccination Generation 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/NCT00006184
GET https://conductscience.org/api/trials/v1/NCT00006184/events?page=2