Trial · NCT06956170
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to approximately 120 weeks | 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 is defined as 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 approximately 407 weeks | Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause. |
| Secondary | Duration of Response (DoR) | Up to approximately 407 weeks | Duration of Response (DoR) defined as the time from first documented evidence of partial response (PR) or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Up to approximately 407 weeks | MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by NGS at 10\^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 407 weeks | ORR is defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. |
| Secondary | Complete Response Rate (CRR) | Up to approximately 407 weeks | Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria. |
| Secondary | Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | Up to approximately 407 weeks | VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. |
| Secondary | Time to Best Response (TTBR) | Up to approximately 407 weeks | Time to Best Response (TTBR) defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG. |
| Secondary | Time to Response (TTR) | Up to approximately 407 weeks | Time to Response (TTR) defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG. |
| Secondary | Time to Progression (TTP) | Up to approximately 407 weeks | Time to Progression (TTP) defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD. |
| Secondary | Progression-free Survival on Subsequent Line of Therapy (PFS2) | Up to approximately 407 weeks | PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. 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 | Number of Participants With Adverse Events (AEs) | Up to approximately 407 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 approximately 407 weeks | Blood samples will be collected for the analysis of hematology parameters. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Up to approximately 407 weeks | Blood samples will be collected for the analysis of clinical chemistry parameters. |
| Secondary | Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Up to approximately 407 weeks | |
| Secondary | Plasma Concentrations of Belantamab Mafodotin (ADC) | Up to approximately 407 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 approximately 407 weeks | Blood samples will be collected for PK analysis of belantamab mafodotin. |
| Secondary | Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide | Up to approximately 407 weeks | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone |
| Secondary | Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide | Up to approximately 407 weeks | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. |
| Secondary | Maximum Concentration (Cmax) for Pomalidomide | Up to approximately 407 weeks | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. |
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/NCT06956170/registered