Trial · NCT04191616
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 | Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) | From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC | Day 1 cycle 1 to month 12 (8 to 13 month window) | The safety analysis set included all participants who received at least 1 dose of carfilzomib. The analysis was pre-specified until PA DCO only. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occured earlier; Median (min, max) was 8.5 (1.0, 46.6) months | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving MRD[-] Response | From day 1 cycle 1 until the end of study (EOS); the mean duration of KPd treatment as of the EOS was 55.3 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC | Day 1 cycle 1 to month 12 (8 to 13 month window) | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC | Day 1 cycle 1 to month 26 (19 to 26 month window) | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. Only participants who achieved a partial response or better were included in the analysis. | months | MEDIAN |
| SECONDARY | Time to Response as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. Only participants who achieved a partial response or better were included in the analysis. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival (OS) | From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks. | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | months | MEDIAN |
| SECONDARY | Number of Participants With Best Overall Confirmed Response of CR or Better as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT04191616/outcomes