Trial · NCT05405166
Outcomes57
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 57
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The intent-to-treat (ITT) population included all randomized population (all participants who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number by the interactive response technology \[IRT\]). Percentages are rounded off to the tenth decimal place. | percentage of participants | NUMBER |
| PRIMARY | Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State | Pre-dose at Cycle 6 Day 1 | Per Protocol-Pharmacokinetic (PP-PK) population: all randomized participants who met following: at least 11 Isa dose from Cycle 1 Day 1 to Cycle 5 Day 15 (1 dose omission permitted at Cycle 1 only); Isa pre-dose plasma concentration results from PK samples on Cycle 6 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times. | microgram/milliliter (mcg/mL) | MEAN |
| SECONDARY | Very Good Partial Response or Better Rate | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The ITT population included all randomized population. | percentage of participants | NUMBER |
| SECONDARY | Ctrough of Isatuximab at 4 Weeks (CT4W) | Pre-dose at Cycle 2 Day 1 (at 4 weeks) | The CT4W-PK population: all randomized participants who met following: all 4 Isa doses for Cycle 1 administered; Isa pre-dose plasma concentration results from PK samples on Cycle 2 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times. | mcg/mL | MEAN |
| SECONDARY | Percentage of Participants With Infusion Reactions | From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 28 months | The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15 | Cycle 5 Day 15 | The ITT population included all randomized population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The ITT population included all randomized population. Only responders (participants who achieved a response of PR or better subsequently confirmed based on disease assessment by IRC) were included in the analysis. | months | MEDIAN |
| SECONDARY | Time to First Response (TT1R) | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The ITT population included all randomized population. | months | MEDIAN |
| SECONDARY | Time to Best Response (TTBR) | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The ITT population included all randomized population. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From first dose of study medication administration (Day 1) up to a maximum of 57 months | |||
| SECONDARY | Overall Survival (OS) | From first dose of study medication administration (Day 1) up to a maximum of 57 months | |||
| SECONDARY | Progression Free Survival 2 (PFS2) | From first dose of study medication administration (Day 1) up to a maximum of 57 months | |||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months | The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs) | From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months | The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. As pre-specified in the protocol and statistical analysis plan (SAP), ISRs were evaluated only for Isa-SC + Pd arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ctrough of Isatuximab | Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1 | The PK population included all participants with at least 1 available isatuximab concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported. | mcg/mL | MEAN |
| SECONDARY | Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. Total number of actual injections is reported as type of units. | percentage of successful injections | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab | From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months | The ADA population included all participants from safety population with at least 1 ADA result (negative, positive or inconclusive) post-baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)' | Baseline (Cycle 1 Day 1) | The ITT population included all randomized population. Only those participants with data collected at Baseline are reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method' | Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15 | The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method' | Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15 | The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported. | percentage of participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05405166/outcomes