Trial · NCT04891809
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Changes of general health status using questionnaire EQ (EuroQol) 5 dimension (5D) 5 level (5L) (EQ-5D-5L) | After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment) | Changes in general health status will be analyzed by using the questionnaires EQ-5D-5L. QoL. |
| Secondary | Changes in quality of life (QoL) using multiple myeloma specific questionnaire EORTC-QLQ Myeloma (MY) 20 (EORTC-QLQ-MY20) | 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 multiple myeloma-specific questionnaire EORTC-QLQ-MY20. |
| Secondary | Progression-free survival after second line therapy | After end of study treatment until 12 months of follow up as a minimum (until LPLV) | Influence of potential second line therapy on Progression-free Survival |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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