Comparison · NCT01413178-d38b560c
Busulfan + Melphalan vs Melphalan: Number of Participants With Complete Response (CR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Busulfan + Melphalan vs Melphalan: Number of Participants With Complete Response (CR). Trial comparisons, record NCT01413178-d38b560c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01413178-d38b560c
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.115 | 0.0672 | 0.191 | wilson | |
| Risk in group 2 | 0.153 | 0.095 | 0.237 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0377 | -0.135 | 0.0576 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.754 | 0.372 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 0.722 | 0.319 | 1.63 | log | |
| Number needed to treat, for one fewer participant with the outcome on Busulfan + Melphalan than on Melphalan | 26.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Busulfan + Melphalan | Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant | 12 | 104 | OG000 |
| Group 2 | Melphalan | High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant | 15 | 98 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Complete Response (CR)
- Description
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.
- Time frame
- Evaluated 90 days from transplant.
- Population
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Myeloma
- Interventions
- Busulfan, Melphalan, Questionnaire, G-CSF, High Dose Melphalan, Stem cell transplant
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2020-04-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01413178?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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