Trial · NCT01413178
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
NCT01413178, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2020-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma. Trials, record NCT01413178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01413178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
- NCT number
- NCT01413178
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 205 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Myeloma
- Interventions
- Busulfan, Melphalan, Questionnaire, G-CSF, High Dose Melphalan, Stem cell transplant
- First posted
- 2011-08-10
- Last updated
- 2020-04-21
- Results first posted
- 2020-04-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 3 years after transplant | Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation. |
| Secondary | Number of Participants With Complete Response (CR) | Evaluated 90 days from transplant. | Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria. |
| Secondary | Treatment-Related Mortality (TRM) Between 2 Arms. | 100 days post treatment | |
| Secondary | Number of Participants That Had Grade 3-4 Toxicities. | At day 90 post SCT (Stem Cell Transplantation) | |
| Secondary | Overall Survival (OS) | From time of ASCT to 3 years |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | 3 years after transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Complete Response (CR) | Evaluated 90 days from transplant. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment-Related Mortality (TRM) Between 2 Arms. | 100 days post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Had Grade 3-4 Toxicities. | At day 90 post SCT (Stem Cell Transplantation) | participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | From time of ASCT to 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Busulfan + Melphalan | 72 | Participants | ||
| Progression-Free Survival (PFS) | Melphalan | 50 | Participants | ||
| Number of Participants With Complete Response (CR) | Busulfan + Melphalan | 12 | Participants | ||
| Number of Participants With Complete Response (CR) | Melphalan | 15 | Participants | ||
| Treatment-Related Mortality (TRM) Between 2 Arms. | Busulfan + Melphalan | 0 | Participants | ||
| Treatment-Related Mortality (TRM) Between 2 Arms. | Melphalan | 0 | Participants | ||
| Number of Participants That Had Grade 3-4 Toxicities. | Busulfan + Melphalan | Grade 3 - Diarrhea | 5 | participants | |
| Number of Participants That Had Grade 3-4 Toxicities. | Melphalan | Grade 3 - Diarrhea | 4 | participants | |
| Number of Participants That Had Grade 3-4 Toxicities. | Busulfan + Melphalan | Grade 3 - Elevated ALT | 3 | participants | |
| Number of Participants That Had Grade 3-4 Toxicities. | Melphalan | Grade 3 - Elevated ALT | 0 | participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Busulfan + Melphalan | 105 | |
| Overall Study | STARTED | Melphalan | 100 | |
| Overall Study | COMPLETED | Busulfan + Melphalan | 104 | |
| Overall Study | COMPLETED | Melphalan | 98 | |
| Overall Study | NOT COMPLETED | Busulfan + Melphalan | 1 | |
| Overall Study | NOT COMPLETED | Melphalan | 2 |
Source ClinicalTrials.gov
Adverse events94
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 | Arrhythmia | Cardiac disorders | Busulfan + Melphalan | 1 | 104 | |
| other | Arrhythmia | Cardiac disorders | Melphalan | 0 | 98 | |
| other | Atrial fibrillation | Cardiac disorders | Busulfan + Melphalan | 1 | 104 | |
| other | Atrial fibrillation | Cardiac disorders | Melphalan | 1 | 98 | |
| other | Chemo burns | Skin and subcutaneous tissue disorders | Busulfan + Melphalan | 3 | 104 | |
| other | Chemo burns | Skin and subcutaneous tissue disorders | Melphalan | 0 | 98 | |
| other | Diarrhea | Gastrointestinal disorders | Busulfan + Melphalan | 57 | 104 | |
| other | Diarrhea | Gastrointestinal disorders | Melphalan | 82 | 98 | |
| other | Dizziness | Nervous system disorders | Busulfan + Melphalan | 1 | 104 | |
| other | Dizziness | Nervous system disorders | Melphalan | 0 | 98 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Busulfan + Melphalan | 23 | 104 |
| Total, all-cause mortality | Melphalan | 21 | 98 |
| Total, other adverse events | Busulfan + Melphalan | 101 | 104 |
| Total, other adverse events | Melphalan | 98 | 98 |
| Total, serious adverse events | Busulfan + Melphalan | 73 | 104 |
| Total, serious adverse events | Melphalan | 32 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30910541 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Busulfan + Melphalan vs Melphalan: Overall Survival (OS) | Trial comparisons |
| Busulfan + Melphalan vs Melphalan: Treatment-Related Mortality (TRM) Between 2 Arms. | Trial comparisons |
| Busulfan + Melphalan vs Melphalan: Number of Participants With Complete Response (CR) | Trial comparisons |
| Busulfan + Melphalan vs Melphalan: deaths from any cause | Trial comparisons |
| Busulfan + Melphalan vs Melphalan: Progression-Free Survival (PFS) | Trial comparisons |
| Busulfan + Melphalan vs Melphalan: 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/NCT01413178
GET https://conductscience.org/api/trials/v1/NCT01413178/results?page=2