Trial · NCT04246047
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to approximately 41 months | PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis. |
| Secondary | Complete Response Rate (CRR) | Up to 73 months | CRR is defined as percentage of participants with a confirmed complete response or better. |
| Secondary | Overall Response Rate (ORR) | Up to 73 months | ORR is defined as percentage of participants with a confirmed partial response or better. |
| Secondary | Clinical Benefit Rate (CBR) | Up to 73 months | CBR is defined as percentage of participants with a confirmed minimal response (MR) or better |
| Secondary | Duration of Response (DoR) | Up to 73 months | DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first. |
| Secondary | Time to Response (TTR) | Up to 73 months | TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better. |
| Secondary | Time to Progression (TTP) | Up to 73 months | TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 73 months | OS is defined as time from the date of randomization until the date of death due to any cause. |
| Secondary | Progression-free Survival on Subsequent Line of Therapy (PFS2) | Up to 73 months | Progression-free survival on subsequent line of therapy is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Up to 73 months | Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS). |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 73 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. |
| Secondary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to 73 months | Blood samples will be collected for the analysis of hematology parameters. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry | Up to 73 months | Blood samples will be collected for the analysis of clinical chemistry parameters. |
| Secondary | Number of Participants With Clinically Significant Changes in Urine Dipstick | Up to 73 months | Urine samples will be collected for the urine dipstick analysis. |
| Secondary | Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Up to 73 months | |
| Secondary | Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points | Up to 73 months | Blood samples will be collected for PK analysis of belantamab mafodotin. |
| Secondary | Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points | Up to 73 months | Blood samples will be collected for PK analysis of belantamab mafodotin. |
| Secondary | Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points | Up to 73 months | Blood samples will be collected for PK analysis of belantamab mafodotin. |
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Up to 73 months | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers. |
| Secondary | Titers of ADAs Against Belantamab Mafodotin | Up to 73 months | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further to be characterized for antibody titers. |
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.
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GET https://conductscience.org/api/trials/v1/NCT04246047/registered