Trial · NCT05317416
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Assessed for up to approximately 5 years | Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria |
| Secondary | Minimal residual disease Negative rate | 12 months after randomization | per IMWG as assessed via next generation sequencing (NGS) |
| Secondary | Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants | Assessed up to approximately 5 years | Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants |
| Secondary | PFS by BICR per IMWG in IMWG 2025 standard-risk participant | Assessed up to approximately 5 years | PFS by BICR per IMWG in IMWG 2025 standard-risk participant |
| Secondary | Overall Survival | Assessed for up to approximately 5 years | Defined as the time from randomization until death due to any cause |
| Secondary | MRD-negative rate per IMWG 2025 | 12 months after randomization | Assessed via NGS in IMWG 2025 subgroups |
| Secondary | Sustained MRD negative rate | 24 months after randomization | Sustained Minimal Residual Disease negative rate per IMWG criteria as assessed via Next Generation Sequencing |
| Secondary | Progression Free Survival | Assessed for up to approximately 5 years | Progression Free Survival by investigator per IMWG response criteria |
| Secondary | Overall minimal residual disease negative rate | Assessed for up to approximately 5 years | Minimal residual disease negative rate per IMWG criteria |
| Secondary | Duration of minimal residual disease negativity | Assessed for up to approximately 5 years | Minimal residual disease negativity per IMWG criteria |
| Secondary | Sustained minimal residual disease negativity rate | Assessed for up to approximately 5 years | Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months |
| Secondary | Complete response rate | Assessed for up to approximately 5 years | Complete response rate by blinded independent central review and by investigator per IMWG criteria |
| Secondary | Duration of complete response | Assessed for up to approximately 5 years | Duration of complete response by blinded independent central review and by investigator per IMWG criteria |
| Secondary | Progression Free Survival 2 | Assessed for up to approximately 5 years | Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria |
| Secondary | Frequency of adverse events | Up to 90 days after last dose | Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention |
| Secondary | Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome | Assessed for up to approximately 5 years | Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome severity assessed per ASH-ASTCT criteria |
| Secondary | Pre-dose concentrations of elranatamab | Assessed for up to approximately 5 years | Pharmacokinetics of elranatamab (trough concentrations of elranatamab) |
| Secondary | Post-dose concentrations of elranatamab | Assessed for up to approximately 5 years | Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)" |
| Secondary | Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab | Assessed for up to approximately 5 years | Immunogenicity of elranatamab |
| Secondary | Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 | Assessed for up to approximately 5 years | Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05317416/registered