Trial · NCT06679101
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS | Up to approximately 7 years | Defined as the time from the date of randomization to the date of first documented PD per International Myeloma Working Group (IMWG) criteria by Independent Review Committee (IRC) or death from any cause in the absence of progression, whichever occurs first. |
| Primary | Number of Participants Achieving MRD Negative Status | Up to approximately 7 years | Defined as achieving MRD negativity at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by next-generation sequencing (NGS) at least once during the time of confirmed complete response (CR) or better response per IMWG criteria by IRC. |
| Secondary | Overall Survival (OS) | Up to approximately 7 years | |
| Secondary | PFS2 | Up to approximately 7 years | Defined as the time from the date of randomization to the date of documented PD following the first subsequent anti-myeloma therapy or death from any cause, whichever is earlier. |
| Secondary | Number of Participants Achieving CR or Better (CR+) | Up to approximately 7 years | |
| Secondary | Number of Participants Achieving Very Good Partial Response (VGPR) or Better | Up to approximately 7 years | |
| Secondary | Number of Participants Achieving Sustained MRD Negative Status | Up to approximately 7 years | Defined as achieving MRD negative status at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR+ response per IMWG criteria by IRC. |
| Secondary | Duration of Response (DoR) | Up to approximately 7 years | |
| Secondary | Time to Second Next Line Therapy (TTST) | Up to approximately 7 years | |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to approximately 7 years | |
| Secondary | Number of Participants With Ocular Findings on Ophthalmic Exam | Up to approximately 7 years | |
| Secondary | Maximum Post-baseline Patient-Reported Outcomes Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) Score | Up to approximately 7 years | |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 | Up to approximately 7 years | |
| Secondary | Change From Baseline in EORTC QLQ-MY20 | Up to approximately 7 years | |
| Secondary | Plasma Concentrations of Belantamab Mafodotin | Up to approximately 7 years | |
| Secondary | Plasma Concentrations of Cysteine Maleimidocaproyl Monomethyl Auristatin F (cys-mcMMAF) | Up to approximately 7 years |
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/NCT06679101/registered