Trial · NCT06868654
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 32 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 | Overall Survival (OS) | Up to 255 weeks | OS is defined as time from the date of randomization until the date of death due to any cause. |
| Secondary | Duration of Response (DoR) | Up to 255 weeks | DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Up to 255 weeks | Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative by next generation sequencing (NGS). |
| Secondary | Complete Response Rate (CRR) | Up to 255 weeks | CRR is defined as percentage of participants with a confirmed complete response (CR) or better (i.e., CR, stringent Complete Response (sCR)). |
| Secondary | Overall Response Rate (ORR) | Up to 255 weeks | ORR is defined as percentage of participants with a confirmed partial response (PR) or better (i.e. PR, Very Good Partial Response \[VGPR\], CR or sCR). |
| Secondary | Clinical Benefit Rate (CBR) | Up to 255 weeks | CBR is defined as percentage of participants with a confirmed minimal response (MR) or better per International Myeloma Working Group (IMWG). |
| Secondary | Time to Response (TTR) | Up to 255 weeks | 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 255 weeks | TTP is defined as the time from the date of randomization until the earliest date of documented PD or death due to PD. 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 | Progression-free Survival on Subsequent Line of Therapy (PFS2) | Up to 255 weeks | PFS2 is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new anti-myeloma 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 | Number of Participants With Adverse Events (AEs) | Up to 255 weeks | 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. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary). |
| Secondary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to 255 weeks | Blood samples will be collected for the analysis of hematology parameters. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry | Up to 255 weeks | 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 255 weeks | Urine samples will be collected for the urine dipstick analysis. |
| Secondary | Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Up to 255 weeks | |
| Secondary | Plasma Concentrations of Belantamab Mafodotin (Total Antibody) | Up to 255 weeks | Blood samples will be collected for PK analysis of belantamab mafodotin. |
| Secondary | Plasma Concentrations of Belantamab Mafodotin (ADC) | Up to 255 weeks | Blood samples will be collected for PK analysis of belantamab mafodotin. |
| Secondary | Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) | Up to 255 weeks | 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 255 weeks | Serum samples will be 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 255 weeks | Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be further tested in screening assay, and positive samples will be further 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
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GET https://conductscience.org/api/trials/v1/NCT06868654/registered