Trial · NCT04270409
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
NCT04270409, Phase 3, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma. Trials, record NCT04270409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04270409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
- NCT number
- NCT04270409
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 337 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Plasma Cell Myeloma
- Interventions
- Isatuximab SAR650984, Lenalidomide, Dexamethasone, Montelukast or equivalent, Acetaminophen, Diphenhydramine or equivalent, Methylprednisolone or equivalent
- First posted
- 2020-02-17
- Last updated
- 2025-12-12
- Other registries' IDs
- eudract:2019-003139-47
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part | Up to approximately 63 months | |
| Primary | Plasma concentration of isatuximab during the treatment period - Safety Run-in Part | After first infusion from Cycle 1 Day 1 to Day 28 in safety run-in part | |
| Primary | Receptor density/receptor occupancy Safety Run-in Part | Baseline to Cycle 2 Day 1 (each cycle is 28 days) | Change in CD38 receptor occupancy from baseline |
| Primary | Progression-free survival (PFS) Randomized Phase 3 Part | Up to approximately 114 months | PFS defined as the time from randomization to MM (SLiM CRAB criteria) or other related conditions based on independent review committee (IRC) assessment according to 2014 International Myeloma Working Group (IMWG) criteria or death from any cause, whichever happens first |
| Secondary | Overall Response Rate (ORR)- Safety Run-in Part | Up to approximately 63 months | ORR defined as the proportion of participants with best overall response (BOR) recorded as partial response (PR) or better according to 2016 IMWG criteria |
| Secondary | Duration of Response (DOR) - Safety Run-in Part | Up to approximately 63 months | DOR defined as the time from the date of the first response to date of first progressive disease (PD) or death, whichever happens first. |
| Secondary | Minimal residual disease (MRD) negativity -Safety Run-in Part | Up to approximately 36 months | MRD negativity defined as the proportion of participants for whom MRD is negative in participants achieving very good partial response (VGPR) or above. |
| Secondary | Time to diagnostic (SLiM CRAB) progression or death - Safety Run-in Part | Up to approximately 63 months | Time to diagnostic (SLiM CRAB) progression or death defined as the time from the date of the first study intervention administration to diagnosis of SLiM CRAB or other related conditions progression or death from any cause, whichever happens first. |
| Secondary | Time to first-line treatment for multiple myeloma (MM) - Safety Run-in Part | Up to approximately 63 months | Time to first-line treatment for MM defined as the time from the date of the first study intervention administration to first-line treatment for MM. |
| Secondary | Number of participants with anti-drug antibodies (ADA) against isatuximab- Safety Run-in Part | Up to approximately 63 months |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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/NCT04270409
GET https://conductscience.org/api/trials/v1/NCT04270409/registered?page=2