Trial · NCT05280275
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Dose-Limiting Toxicity (DLT) | Up to 28 days | The number (%) of participants and 95% CI with the DLT in each of the cohorts 1-2, using the DLT evaluable population. |
| Primary | Part 1 and 2: Adverse Events (AEs) and Serious adverse events (SAEs) | Up to 4 years | The number (%) of participants with AEs and SAEs in each of the cohorts 1-2, using the DLT evaluable and Safety populations. |
| Primary | Part 1 and 2: Ocular toxicity | Up to 4 years | Number of participants with ocular toxicity of Grade 2 or higher (per KVA scale). |
| Primary | Part 2: Overall Response Rate (ORR) | Up to 4 years | ORR as per IMWG by Investigator assessment; defined as the percentage of participants with a confirmed partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR) (For the 'intention to treat' (ITT) population). |
| Secondary | Part 1: Overall Response Rate | Up to 4 years | ORR and 95% CI as per IMWG by Investigator Assessment. ORR is defined as the percentage of participants with a confirmed PR, VGPR, CR or sCR. |
| Secondary | Part 1 and 2: Lenalidomide Relative Dose Intensity (RDI) | Up to 4 years | The RDI is defined as the percentage of the total administered over the total planned lenalidomide dose. |
| Secondary | Part 1 and 2: Cumulative dose of belantamab mafodotin | Up to 4 years | Cumulative belantamab mafodotin dose of (DLT evaluable population, safety population) administered in combination with daratumumab, lenalidomide and dexamethasone, i.e., the total dose of belantamab mafodotin that was administered. |
| Secondary | Part 1: Very good partial response | Up to 4 years | VGPR+ and 95% CI as per IMWG by Investigator Assessment (ITT population) \[Part 1 only\]; ORR is defined as the percentage of participants with a confirmed VGPR, CR or sCR. |
| Secondary | Part 1 and 2: Time to response (TTR) | Up to 4 years | TTR as per IMWG by Investigator Assessment (ITT population). TTR is defined as the time (in months) between the date of randomization and the first evidence of confirmed response (PR or better) for participants who achieve a response (i.e., confirmed PR or better). Descriptive methods will be used for the estimation of the time to response (i.e., mean, standard deviation, median, 1st and 3rd quartiles, minimum value and maximum value). |
| Secondary | Part 1 and 2: Duration of response | Up to 4 years | DoR as per IMWG by Investigator Assessment (ITT population). DoR is defined as the time (months) from first evidence of confirmed PR or better until the earliest date of: documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved a response of PR or better. For alive and progression-free participants, data will be censored at the date of initiation of the subsequent line of treatment or at the last date of follow-up that the participant was known to be alive and progression-free. The Kaplan-Meier method will be used for the estimation of DoR. The median DoR will be presented along with the respective 95% confidence intervals \[CIs\]) and the 1st and 3rd quartiles. |
| Secondary | Part 1 and 2: Complete response rate (CRR) | Up to 4 years | CRR as per IMWG by Investigator Assessment (ITT population). CRR is defined as the percentage of participants with a confirmed CR or sCR. The denominator will be the total number of participants in each population, cohort and group respectively. |
| Secondary | Part 1 and 2: Minimal residual disease (MRD) negativity rate | Up to 4 years | MRD negativity rate (ITT population) is defined as the number (%) of participants who achieve MRD negativity (at or below the threshold of 10-5), assessed via Next Generation Flow (NGF). The denominator will be the total number of participants in each population, cohort and Group respectively. |
| Secondary | Part 1 and 2: Progression free survival (PFS) | Up to 4 years | PFS as per IMWG by Investigator Assessment (ITT population, Safety population). PFS is defined as the time (in months) from randomization until the earliest date of documented PD per IMWG, or death due to any cause. For participants who neither progress nor die, the PFS will be censored at the date of their last adequate disease assessment. For participants who start a new anti-myeloma treatment, PFS will be censored at the date of the last adequate assessment before the start of the new treatment. For a randomized participant who does not have any post-baseline disease assessments and who has not died, PFS will be censored at the randomization date. The median PFS will be analyzed with the Kaplan Meier method and presented along with the respective 95% CI and the 1st and 3rd quartiles. |
| Secondary | Part 1 and 2: Overall survival (OS) | Up to 4 years | OS is defined as the time from first dose/randomization until death due to any cause. If a participant is not known to have died, survival time will be censored at the date of last contact ("last known date alive"). The median OS will be analyzed using the Kaplan-Meier method and will be presented with the respective 95% CI and the 1st and 3rd quartiles. |
| Secondary | Part 1 and 2: Abnormal ocular findings | Up to 4 years | Number (%) of participants with abnormal ocular findings (on ophthalmic exam) (DLT evaluable population, Safety population). |
| Secondary | Part 1 and 2: Pharmacokinetics (PK) analysis (PK population) - Peak plasma Concentration (Cmax) | Up to 4 years | Concentration-time data: linear and semi-logistic unique profiles of concentration-time and the mean and median profiles (as applicable) will be graphically represented for belantamab mafodotin. Belantamab mafodotin concentrations will be presented for each participant and summarized (as applicable) at each PK timepoint and cohort. PK parameters: Concentration-time data can be presented, considering data from other studies and analyzed using a population PK analysis. The Cmax will be calculated. The results of these analyses can be included in a separate report. PK parameters will be descriptively summarized using mean, median, standard deviation (SD), and 95% CI, minimum/maximum value, geometric mean and coefficient of variation. |
| Secondary | Part 1 and 2: PK analysis (PK population) - Area under the plasma concentration versus time curve (AUC) | Up to 4 years | Concentration-time data: linear and semi-logistic unique profiles of concentration-time and the mean and median profiles (as applicable) will be graphically represented for belantamab mafodotin. Belantamab mafodotin concentrations will be presented for each participant and summarized (as applicable) at each PK timepoint and cohort. PK parameters: Concentration-time data can be presented, considering data from other studies and analyzed using a population PK analysis. The AUC will be calculated. The results of these analyses can be included in a separate report. PK parameters will be descriptively summarized using mean, median, standard deviation (SD), and 95% CI, minimum/maximum value, geometric mean and coefficient of variation. |
| Secondary | Part 1 and 2: Ocular Surface Disease Index (OSDI) | Up to 4 years | Number of participants with changes from baseline and proportion of participants with within-participant meaningful change in self reported ocular symptoms and related impacts as measured by the OSDI questionnaire. |
| Secondary | Part 1 and 2: Alternate corneal AE management | Up to 4 years | KVA events, dose holds, worst post-baseline BCVA and incidence of Grade 4 corneal findings will be descriptively summarized using frequencies and proportions. No statistical comparison will be made between the 2 groups. |
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.
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