Trial · NCT02541383
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
NCT02541383, Phase 3, Completed, Intergroupe Francophone du Myelome; results first posted 2025-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma. Trials, record NCT02541383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02541383
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
- NCT number
- NCT02541383
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,085 participants, actual
- Lead sponsor
- Intergroupe Francophone du Myelome
- Conditions
- Multiple Myeloma
- Interventions
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab, Daratumumab
- First posted
- 2015-09-04
- Last updated
- 2025-04-13
- Other registries' IDs
- eudract:2014-004781-15
- Results first posted
- 2025-04-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-Consolidation Stringent Complete Response (sCR) Rate | At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT | 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. |
| Primary | Progression Free Survival (PFS) Post Completion of Maintenance Therapy | From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date). | Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy. |
| Secondary | Progression Free Survival (PFS) From First Randomization up to the End of the Study | From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study | Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-Consolidation Stringent Complete Response (sCR) Rate | At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT | All participants randomized in the first randomization. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (PFS) Post Completion of Maintenance Therapy | From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date). | All participants randomized in the second randomization even if they did not receive any study treatment dose. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) From First Randomization up to the End of the Study | From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study | All participants randomized in the first randomization even if they did not receive any study treatment dose. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-Consolidation Stringent Complete Response (sCR) Rate | Arm A Part 1 | 110 | Participants | ||
| Post-Consolidation Stringent Complete Response (sCR) Rate | Arm B Part 1 | 157 | Participants | ||
| Progression Free Survival (PFS) Post Completion of Maintenance Therapy | Arm A Part 2 | 46.7 | 95% Confidence Interval 40.0 to NA | Months | |
| Progression Free Survival (PFS) Post Completion of Maintenance Therapy | Arm B Part 2 | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) From First Randomization up to the End of the Study | Arm A - Part 1 up to End of Study | 52.8 | 95% Confidence Interval 47.5 to 58.7 | Months | |
| Progression Free Survival (PFS) From First Randomization up to the End of the Study | Arm B - Part 1 up to End of Study | 83.7 | 95% Confidence Interval 70.2 to NA | Months |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VTd Only | 114 | |
| Overall Study | STARTED | DVTd Only * Arm/Group Title: Characters Remaining: 91 | 85 | |
| Overall Study | STARTED | VTd-OBS | 215 | |
| Overall Study | STARTED | VTd-DARA | 213 | |
| Overall Study | STARTED | DVTd-OBS | 229 | |
| Overall Study | STARTED | DVTd-DARA | 229 | |
| Overall Study | COMPLETED | VTd Only | 53 | |
| Overall Study | COMPLETED | DVTd Only * Arm/Group Title: Characters Remaining: 91 | 38 | |
| Overall Study | COMPLETED | VTd-OBS | 165 | |
| Overall Study | COMPLETED | VTd-DARA | 170 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,640
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 | Anaemia | Blood and lymphatic system disorders | VTd - Part 1 | 78 | 538 | |
| other | Anaemia | Blood and lymphatic system disorders | DVTd - Part 1 | 74 | 536 | |
| other | Anaemia | Blood and lymphatic system disorders | VTd-OBS - Part 2 | 7 | 215 | |
| other | Anaemia | Blood and lymphatic system disorders | VTd-DARA - Part 2 | 8 | 211 | |
| other | Anaemia | Blood and lymphatic system disorders | DVTd-OBS - Part 2 | 4 | 229 | |
| other | Anaemia | Blood and lymphatic system disorders | DVTd-DARA - Part 2 | 2 | 229 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | VTd - Part 1 | 13 | 538 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | DVTd - Part 1 | 27 | 536 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | VTd-OBS - Part 2 | 1 | 215 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | VTd-DARA - Part 2 | 0 | 211 |
1 to 10 of 2,640Source ClinicalTrials.gov
See all 2,640 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VTd - Part 1 | 139 | 542 |
| Total, all-cause mortality | DVTd - Part 1 | 83 | 543 |
| Total, all-cause mortality | VTd-OBS - Part 2 | 48 | 215 |
| Total, all-cause mortality | VTd-DARA - Part 2 | 41 | 211 |
| Total, all-cause mortality | DVTd-OBS - Part 2 | 21 | 229 |
| Total, all-cause mortality | DVTd-DARA - Part 2 | 25 | 229 |
| Total, other adverse events | VTd - Part 1 | 529 | 538 |
| Total, other adverse events | DVTd - Part 1 | 534 | 536 |
| Total, other adverse events | VTd-OBS - Part 2 | 170 | 215 |
| Total, other adverse events | VTd-DARA - Part 2 | 194 | 211 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers11
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A Part 1 vs Arm B Part 1: Post-Consolidation Stringent Complete Response (sCR) Rate |
Source 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/NCT02541383
GET https://conductscience.org/api/trials/v1/NCT02541383/events?page=2