Trial · NCT05060627
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) during the triplet-therapy in phase I. | At the end of the first 4-week cycle following a 3+3 design. | To determine the maximum tolerated dose, and the recommended phase 2 dose of belantamab mafodotin in combination with carfilzomib and dexamethasone, number of participants with adverse events (AEs) during the triplet-therapy in phase 1 will be evaluated. |
| Primary | Overall Response Rate (ORR) | 12 months. | Percentage of participants with a confirmed partial response (PR) or better (PR, VGPR, CR, sCR). |
| Primary | Minimal Residual Disease (MRD) negativity rate | At the time of CR/VGPR, and in all patients at month 12, 18, and 24, and yearly thereafter. | The percentage of participants who are MRD negative by next-generation flow cytometry (NGF). |
| Primary | Complete Response Rate (CRR) | 12 months. | The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR)). |
| Primary | Incidence of deaths and primary cause of death. | Throughout the study. Approximately 60 months. | Frequency and percentage of deaths and primary cause of death. |
| Primary | Incidence of adverse events (AEs). | Throughout the study. Approximately 60 months. | Frequency and percentage of AEs |
| Primary | % of patients with changes in hematologic laboratory parameters | Throughout the study. Approximately 60 months. | Percentage of patients who present differences in hematologic laboratory parameters from baseline values . |
| Primary | % of patients with changes in blood chemistry laboratory parameters | Throughout the study. Approximately 60 months. | Percentage of patients who present differences in blood chemistry panel from baseline values. |
| Primary | Frequency of ocular findings on ophthalmic exam | Throughout the study. Approximately 60 months. | Ocular findings on ophthalmic exam |
| Secondary | Duration of Response (DoR) | Throughout the study. Approximately 60 months. | Time from first documented evidence of PR or better until progressive disease (PD) or death due to PD among participants who achieved PR or better. |
| Secondary | Progression-Free Survival (PFS) | Throughout the study. Approximately 60 months. | Time from the start of treatment until the earliest date of documented disease progression or death due to any cause. |
| Secondary | Progression-Free Survival (PFS) at 12 months. | 12 months | Time from the start of treatment until the earliest date of documented disease progression or death due to any cause. |
| Secondary | Time to Response (TTR) | Throughout the study. Approximately 60 months. | Time from the start of treatment and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better. |
| Secondary | Overall Survival (OS) | Throughout the study. Approximately 60 months. | Time from the start of treatment until the date of death due to any cause |
| Secondary | Percentage of patients upgrading the response category | At 12 and 24 months | Percentage of patients upgrading/deepening the response (converting from partial response to VGPR, etc.) |
| Secondary | Percentage of patients achieving minimal residual disease negativity using EuroFlow Panel with a sensitivity of 10*(-6). | At 12, 18 and 24 months | Percentage of patients achieving minimal residual disease negativity using EuroFlow Panel with a sensitivity of 10\*(-6) |
| Secondary | Percentage of patients converting from positive MRD to undetectable MRD following EuroFlow panel with a sensitivity of 10*(-6) | At 12, 24, 36, 48 and 60 months. | Percentage of patients converting from positive MRD to undetectable MRD following EuroFlow panel with a sensitivity of 10-6 |
| Secondary | Incidence of Treatment related adverse events | Throughout the study. Approximately 60 months. | Frequency and percentage of Treatment related adverse events |
| Secondary | Percentage of patients discontinuing therapy due to AEs. | Throughout the study. Approximately 60 months. | Percentage of patients discontinuing therapy due to AEs. |
| Secondary | Percentage of patients requiring dose modifications. | Throughout the study. Approximately 60 months. | Percentage of patients requiring dose modifications. |
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/NCT05060627/registered