Trial · NCT00177047
Autologous Transplant for Multiple Myeloma
NCT00177047, Phase 2, Phase 3, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2021-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Autologous Transplant for Multiple Myeloma. Trials, record NCT00177047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00177047
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Transplant for Multiple Myeloma
- NCT number
- NCT00177047
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 363 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Multiple Myeloma
- Interventions
- Stem Cell Transplant, Cyclophosphamide + Mesna, Melphalan, Granulocyte-colony stimulating factor
- First posted
- 2005-09-15
- Last updated
- 2021-11-09
- Results first posted
- 2021-11-09
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving a Complete Response | 100 Days post transplant | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas. |
| Primary | Number of Participants Achieving a Complete Response | 6 months post transplant | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas. |
| Primary | Number of Participants Achieving a Complete Response | 12 months post transplant | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas. |
| Secondary | Number of Patients With Extended Disease-free Survival | 36 Months | Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression. |
| Secondary | Number of Participants With Overall Survival | 1 year | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. |
| Secondary | Number of Participants With Overall Survival | 2 years | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. |
| Secondary | Number of Participants With Overall Survival | 3 years | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. |
| Secondary | Count of Participants Experiencing Transplant Related Mortality | 1 year | In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation. |
| Secondary | Number of Participants Experiencing Incidence of Relapse | 1 year | The return of disease after its apparent recovery/cessation. |
| Secondary | Number of Participants With Disease Progression | 1 year | Myeloma Response Definitions - Using International Uniform Response Criteria: Progressive Disease (PD) For patients not in CR or sCR, progressive disease requires one or more of the following: * \>25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL. * \>25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours. * Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl), only in patients without measurable paraprotein in the serum and urine. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving a Complete Response | 100 Days post transplant | 173 participants were not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Achieving a Complete Response | 6 months post transplant | 54 participants were not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Achieving a Complete Response | 12 months post transplant | 55 participants were not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Extended Disease-free Survival | 36 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Overall Survival | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Overall Survival | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Overall Survival | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Count of Participants Experiencing Transplant Related Mortality | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Incidence of Relapse | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Disease Progression | 1 year | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving a Complete Response | Chemotherapy and Transplant Treatment | 51 | Participants | ||
| Number of Participants Achieving a Complete Response | Chemotherapy and Transplant Treatment | 99 | Participants | ||
| Number of Participants Achieving a Complete Response | Chemotherapy and Transplant Treatment | 123 | Participants | ||
| Number of Patients With Extended Disease-free Survival | Chemotherapy and Transplant Treatment | 164 | Participants | ||
| Number of Participants With Overall Survival | Chemotherapy and Transplant Treatment | 349 | Participants | ||
| Number of Participants With Overall Survival | Chemotherapy and Transplant Treatment | 328 | Participants | ||
| Number of Participants With Overall Survival | Chemotherapy and Transplant Treatment | 301 | Participants | ||
| Count of Participants Experiencing Transplant Related Mortality | Chemotherapy and Transplant Treatment | 3 | Participants | ||
| Number of Participants Experiencing Incidence of Relapse | Chemotherapy and Transplant Treatment | 69 | Participants | ||
| Number of Participants With Disease Progression | Chemotherapy and Transplant Treatment | 34 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy and Transplant Treatment | 363 | |
| Overall Study | COMPLETED | Chemotherapy and Transplant Treatment | 363 | |
| Overall Study | NOT COMPLETED | Chemotherapy and Transplant Treatment | 0 |
Source ClinicalTrials.gov
Adverse events66
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 | Acute kidney injury | Renal and urinary disorders | Chemotherapy and Transplant Treatment | 4 | 363 | 4 |
| other | Akinesis | Nervous system disorders | Chemotherapy and Transplant Treatment | 1 | 363 | 1 |
| other | Edema | Renal and urinary disorders | Chemotherapy and Transplant Treatment | 2 | 363 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Chemotherapy and Transplant Treatment | 1 | 363 | 2 |
| other | Artrial fibrillation | Cardiac disorders | Chemotherapy and Transplant Treatment | 8 | 363 | 8 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Chemotherapy and Transplant Treatment | 1 | 363 | 1 |
| other | Blood clot | Vascular disorders | Chemotherapy and Transplant Treatment | 3 | 363 | 3 |
| other | bowl obstruction | Gastrointestinal disorders | Chemotherapy and Transplant Treatment | 5 | 363 | 5 |
| other | Cardiomyopathy | Cardiac disorders | Chemotherapy and Transplant Treatment | 2 | 363 | 2 |
| other | Cataract | Eye disorders | Chemotherapy and Transplant Treatment | 4 | 363 | 4 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy and Transplant Treatment | 62 | 363 |
| Total, other adverse events | Chemotherapy and Transplant Treatment | 194 | 363 |
| Total, serious adverse events | Chemotherapy and Transplant Treatment | 2 | 363 |
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/NCT00177047
GET https://conductscience.org/api/trials/v1/NCT00177047/events?page=2