Trial · NCT04270409
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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 | |
| Secondary | PFS in participants with chromosomal abnormalities - Safety Run-In Part | Up to approximately 63 months | Association of chromosomal abnormalities with survival outcomes |
| Secondary | Overall Survival (OS) in participants with chromosomal abnormalities - Safety Run-In Part | Up to approximately 63 months | Association of chromosomal abnormalities with survival outcomes |
| Secondary | Minimal residual disease (MRD) negativity - Randomized Phase 3 Part | Up to approximately 36 months | MRD negativity defined as the proportion Number of participants for whom MRD is negative in participants achieving VGPR or above. |
| Secondary | Sustained MRD negativity - Randomized Phase 3 Part | Up to approximately 36 months | Sustained MRD negativity defined as the proportion of participants for whom MRD is negative during a minimum period of one year. |
| Secondary | Second PFS (PFS2) - Randomized Phase 3 Part | Up to approximately 144 months | PFS2 defined as the time from the date of randomization to the date of first documentation of PD (as reported by the Investigator) after initiation of further treatment for MM or the date of death from any cause, whichever happens first |
| Secondary | OS - Randomized Phase 3 Part | Up to approximately 114 months | OS defined as the time from date of randomization to death from any cause. |
| Secondary | Complete response (CR) rate - Randomized Phase 3 Part | Up to approximately 114 months | Percentage of participants with a CR (or better \[stringent CR (sCR)\]) as defined by 2016 IMWG response criteria, assessed by an IRC based on central laboratory values. |
| Secondary | Overall Response Rate (ORR) - Randomized Phase 3 Part | Up to approximately 114 months | ORR is defined as the proportion of participants with BOR recorded as PR or better according to the 2016 IMWG criteria, assessed by an IRC based on central laboratory values. |
| Secondary | Duration of response (DOR) - Randomized Phase 3 Part | Up to approximately 114 months | DOR is defined as the time from the date of the first IRC determined response to the date of first IRC PD, or death, whichever happens first. |
| Secondary | Time to diagnostic (SLiM CRAB) progression - Randomized Phase 3 Part | Up to approximately 114 months | Time to diagnostic (SLiM CRAB) progression defined as the time from randomization to the date of diagnosis of SLiM CRAB progression based on IRC assessment. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04270409/registered