Trial · NCT05005442
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Up to approximately 6 weeks | All participants who received at least one dose of study intervention and that finished the DLT evaluation period without a DLT or experienced a DLT in the DLT evaluation period. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 27 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 24 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had ORR measured by Lugano 2014 Classification. | Percentage of Participants | NUMBER |
| SECONDARY | ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had ORR measured by the 2016 IMWG Response Criteria. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had a response measured by measured by Lugano 2014 Classification. | Months | MEDIAN |
| SECONDARY | DOR as Assessed by 2016 IMWG Response Criteria (Cohort E) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had a response measured by measured by 2016 IMWG Response Criteria. No participants met the pre-specified analysis criteria for DOR in Cohort E (i.e., no participants with a response) and therefore DOR is unavailable for Cohort E. | ||
| SECONDARY | Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and were evaluated using Lugano 2014 Classification. | Percentage of Participants | NUMBER |
| SECONDARY | DCR as Assessed by 2016 IMWG Response Criteria (Cohort E) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and were evaluated using 2016 IMWG Response Criteria. | Percentage of Participants | NUMBER |
| SECONDARY | Lowest Plasma Concentration (Ctrough) of Vibostolimab | Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks | All participants who received at least one dose of intervention and had data for the corresponding cycle. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Vibostolimab | Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks | All participants who received at least one dose of intervention and had data for the corresponding cycle. | ug/mL | GEOMETRIC_MEAN |
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/NCT05005442/outcomes