Comparison · NCT02541383-287370dc
Arm A Part 1 vs Arm B Part 1: Post-Consolidation Stringent Complete Response (sCR) Rate
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm A Part 1 vs Arm B Part 1: Post-Consolidation Stringent Complete Response (sCR) Rate. Trial comparisons, record NCT02541383-287370dc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02541383-287370dc
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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 | 0.203 | 0.171 | 0.239 | wilson | |
| Risk in group 2 | 0.289 | 0.253 | 0.329 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0862 | -0.137 | -0.035 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.702 | 0.567 | 0.868 | log | |
| Odds ratio, group 1 over group 2 | 0.626 | 0.473 | 0.828 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A Part 1 than on Arm B Part 1 | 11.6 | 7.31 | 28.6 | from the risk difference interval |
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 | Arm A Part 1 | Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)~Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation | 110 | 542 | OG000 |
| Group 2 | Arm B Part 1 | Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab~Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation | 157 | 543 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Post-Consolidation Stringent Complete Response (sCR) Rate
- Description
Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT.~According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
- Time frame
- At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
- Population
- All participants randomized in the first randomization.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
- NCT number
- NCT02541383
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab, Daratumumab
- Lead sponsor
- Intergroupe Francophone du Myelome
- Results first posted
- 2025-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02541383?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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