Trial · NCT05573802
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
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 with DLTs 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 using the DLT evaluable and Safety populations |
| Primary | Part 1 and 2: Ocular Toxicity | Up to 4 years | The number (%) of participants with grade 2 or above KVA events |
| Primary | Part 2: Overall Response Rate (ORR) | Up to 4 years | ORR as per International Myeloma Working Group (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 Complete Response sCR in the intent-to-treat (ITT) set. |
| 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: Nirogacestat Relative Dose Intensity (RDI) | Up to 4 years | The RDI is defined as the percentage of the total administered over the total planned nirogacestat dose. |
| Secondary | Part 1 and 2: Cumulative dose of bentalamab mafodotin | Up to 4 years | Cumulative administered dose of belantamab mafodotin in combination with lenalidomide, dexamethasone and nirogacestat i.e., the total dose of belantamab mafodotin that was administered. |
| Secondary | Part 1: Overall Response Rate (ORR) | Up to 4 years | Overall Response Rate as per IMWG by Investigator Assessment |
| 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). |
| Secondary | Part 1 and 2: Duration of Response (DoR) | Up to 4 years | 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 FU that the participant was known to be alive and progression-free. |
| Secondary | Part 1 and 2: Complete Response Rate (CRR) | Up to 4 years | 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 and group respectively. |
| Secondary | Part 1 and 2: Very Good Partial Response (VGPR) or better | Up to 4 years | VGPR or better as per IMWG by Investigator Assessment (ITT population). VGPR or better rate is defined as the percentage of participants with a confirmed VGPR, CR or sCR. The denominator will be the total number of participants in each population and group respectively. |
| Secondary | Part 1 and 2: Minimal Residual Disease (MRD) negative rate | Up to 4 years | MRD negativity rate (ITT population); defined as the number (%) of participants who achieve MRD negativity (at or below the threshold of 10\^-5), assessed via NGF. The denominator will be the total number of participants in each population 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. |
| 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"). |
| 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 | 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. Additionally, concentration-time and the mean and median profiles (as applicable) will be graphically represented for nirogacestat. Nirogacestat concentrations will be presented for each participant and summarized (as applicable) at each PK timepoint. |
| Secondary | Part 1 and 2:Ocular symptoms and related impacts | 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. |
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
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GET https://conductscience.org/api/trials/v1/NCT05573802/registered