Trial · NCT04751877
Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).
NCT04751877, Phase 3, Active not recruiting, Poitiers University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years). Trials, record NCT04751877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04751877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).
- NCT number
- NCT04751877
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 270 participants, actual
- Lead sponsor
- Poitiers University Hospital
- Conditions
- Multiple Myeloma, Myeloma
- Interventions
- Isatuximab, Lenalidomide, Bortezomib, Dexamethasone
- First posted
- 2021-02-12
- Last updated
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal Residual Disease (MRD) rate at 10-5 at 18 months | at 18 months | Proportion of patients with a reduction tumoral mass ≥50 percent who experience a Minimal Residual Disease (MRD) 10-5 per IMWG (International Myeloma Working Group) criteria. |
| Secondary | Safety of trial treatments | Up to 5 years | List of AE frequency (AE assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 5.0) |
| Secondary | To determine the best response to the treatment | Up to 5 years | Per International Myeloma Working Group (IMWG) criteria |
| Secondary | Progression Free survival | Up to 5 years | Time to relapse or death, whatever occurs first |
| Secondary | To determine the time to reach MRD negative rate at 10-5 | Up to 5 years | The time from randomization to the date of the first MRD negative rate at 10-5 |
| Secondary | To determine the time to loss of MRD negative rate at 10-5 | Up to 5 years | Time from randomization or from the date of MRD negative at 10-5 to the date of MRD positive at 10-5 |
| Secondary | To evaluate the MRD rate at 10-5 at 12 months, and yearly (and at 10-6) | Up to 5 years | Proportion of patients with a reduction tumoral mass ≥75 percent or who has reached at least SD and with MRD negative at the previous MRD assessment who experience a Minimal Residual Disease (MRD) 10-5 per IMWG (International Myeloma Working Group) criteria. |
| Secondary | To determine the rate of loss of MRD at 10-5 at each time point | Up to 5 years | Proportion of patients with MRD negative at 10-5 who lose the MRD negative status at the next evaluation. |
| Secondary | To determine the sustained MRD rate at 10-5 (similar time points) | Up to 5 years | Proportion of patients with sustained MRD in bone marrow aspirate (\< 10-5) between 2 evaluations as determined in the protocol. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38830994 | 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 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/NCT04751877
GET https://conductscience.org/api/trials/v1/NCT04751877/registered