Trial · NCT04891809
Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM
NCT04891809, Phase 2, Active not recruiting, Arbeitsgemeinschaft medikamentoese Tumortherapie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM. Trials, record NCT04891809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04891809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM
- NCT number
- NCT04891809
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 198 participants, estimated
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- Isatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide, Dexamethasone Oral
- First posted
- 2021-05-18
- Last updated
- 2025-04-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with MRD (minimal residual disease) negativity (defined by NGF [next generation flow] at 10^-5) after end of induction treatment in the two arms. | After 8 months of induction treatment (8 cycles, each cyle is 28 days) | To demonstrate the benefit of isatuximab in combination with lenalidomide and low-dose dexamethasone followed by isatuximab and lenalidomide maintenance therapy in changing the proportion of patients with MRD negativity as compared to lenalidomide and low-dose dexamethasone followed by lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM). |
| Secondary | Percentage of patients with response to study treatment | After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment) | Effect of treatment on Overall Response Rate (ORR) including patients with Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm. |
| Secondary | Progression-free Survival | After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up) | Effectiveness of treatments on Progression-free survival (PFS) |
| Secondary | Overall Survival | After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up) | Effectiveness of treatments on Overall Survival (OS) |
| Secondary | Effectiveness of treatments on MRD negativity | After 20 months (8 months of induction treatment and 12 months of maintenance treatemnent) | To evaluate the proportion of patients with MRD negativity (defined by NGF \[next generation flow\] at 10\^-5) after 12 months (13 cycles) of maintenance treatment. |
| Secondary | Effectiveness of treatments on preventing progressive disease | After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up) | To evaluate the Time to Progression (TTP) in each arm. |
| Secondary | Progression-free Survival in different high-risk cytogenetic populations | After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up) | Effectiveness of treatment on PFS in high risk cytogenetic populations defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21. |
| Secondary | Duration of response | After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up) | Length of time between response and progression or death. |
| Secondary | Incidence of treatment-emergent adverse events (Safety and tolerability) | After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment) | Number of participants with treatment-emergent adverse events as assessed by NCI-CTCAE Version 5.0. |
| Secondary | Changes in quality of life (QoL) using general questionnaire European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ) Core 30 (C 30) (EORTC-QLQ-C30) | After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment) | Changes in quality of life will be analyzed by using the cancer patient-specific questionnaire EORTC-QLQ-C30. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31427722 | BACKGROUND |
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/NCT04891809
GET https://conductscience.org/api/trials/v1/NCT04891809/registered