Trial · NCT06918002
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
NCT06918002, Phase 3, Recruiting, Intergroupe Francophone du Myelome
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients. Trials, record NCT06918002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06918002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
- NCT number
- NCT06918002
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 824 participants, estimated
- Lead sponsor
- Intergroupe Francophone du Myelome
- Conditions
- Multiple Myeloma, Newly Diagnosed
- Interventions
- Elranatamab, Lenalidomide (Revlimid®), Daratumumab SC (Darzalex), Autologous Stem Cell Transplantation, Bortezomib (Velcade®), Dexamethasone
- First posted
- 2025-04-09
- Last updated
- 2026-09-30
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (induction/consolidation) from Randomization 1 (R1): to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Minimal Residual Disease (MRD) negativity rate | at end of consolidation, up to 36 months | To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of MRD negativity rate. |
| Primary | Part 2 (maintenance) from Randomization 2 (R2): to assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of Progression Free Survival (PFS). | from the date of second randomization to the date of confirmed PD (IMWG criteria,) or death from any cause, whichever came first, assessed up to 93 monts | To assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of PFS. |
| Primary | Key secondary objectives: Part 1 (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS | PFS defined as the time interval from the date of first randomization to the date of confirmed Progression Disease (IMWG criteria) or death from any cause, whichever occurs first., assessed up to 128 months | To assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS |
| Primary | Key secondary objectives: Part I (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Overal Survival (OS) | up to 128 months | To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of OS |
| Secondary | Part 1 (induction/consolidation) from R1: to assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care | End of consolidation phase, up to 36 months | To assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care: Overall response rate (ORR), Very good partial response (VGPR) rate, Complete response (CR) rate |
| Secondary | Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab | end of maintenance, up to 58 months | To assess the efficacy of maintenance therapy with elranatamab: * Overall response rate (ORR) in maintenance * Very good partial response (VGPR) rate in maintenance * Complete response (CR) rate in maintenance |
| Secondary | assess safety & Tolerability during induction, and during consolidation and maintenance therapy: Adverse events (AE), serious Adrverse events (SAE) and And adverse events of special interest (AESI) rates - Incidence of Treatment-Emergent Adverse Events | through study completion, up to 128 months | To assess safety during induction, and during consolidation and maintenance therapy: AEs, SAE and AESI rates , Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
| Secondary | Throughout the study to evaluate the impact of treatment on health-related Quality of Life (QoL) using Rework questionnaire | through study completion, up to 128 months | To evaluate the impact of treatment on health-related QoL: Rework questionnaire |
| Secondary | Part 2 (maintenance) from Randomization 2 (R2): to assess the efficacy of maintenance therapy with elranatamab, Progression Free Survival 2 form Randomization 2 | up to 128 months | To assess the efficacy of maintenance therapy with elranatamab: \- PFS of subsequent/next treatment line (PFS2 from R2) |
| Secondary | Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab, in term of Minimal Residual Disease negativity | 12 months post R2, up to 71 months | To assess the efficacy of maintenance therapy with elranatamab: \- MRD negativity at 12 months post R2 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06918002
GET https://conductscience.org/api/trials/v1/NCT06918002/registered?page=2