Trial · NCT06140524
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 | Frequency of Adverse Events Interest (AEI) during the safety observation period | 35 days | Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules |
| Primary | Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period | 35 days | Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Primary | Severity of TEAEs during the safety observation period | 35 days | Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Primary | Achievement of Complete Response (CR) as determined by the investigator | Up to 5.5 years | Part 2 |
| Secondary | Frequency of TEAEs | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Severity of TEAEs | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Frequency of Serious Adverse Events (SAEs) | Up to 5.5 years | |
| Secondary | Severity of SAEs | Up to 5.5 years | |
| Secondary | Frequency of laboratory abnormalities | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Severity of laboratory abnormalities | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Minimal Residual Disease (MRD) negativity among participants that achieve a response of CR | Up to 5.5 years | |
| Secondary | Sustained MRD negativity on an annual basis | Up to 3 years after achievement of CR | |
| Secondary | Overall response of Partial Response (PR) or better as determined by the investigator | Up to 5.5 years | |
| Secondary | Duration Of Response (DOR) as determined by the investigator | Up to 5.5 years | |
| Secondary | Biochemical Progression-Free Survival (PFS) as determined by the investigator | Up to 5.5 years | |
| Secondary | Concentration of linvoseltamab in serum over time | Up to 9 months | |
| Secondary | Incidence of Anti-Drug Antibodies (ADAs) to linvoseltamab over the study duration | Up to 5.5. years | |
| Secondary | Magnitude of ADAs to linvoseltamab over the study duration | Up to 5.5. 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/NCT06140524/registered