Trial · NCT05623020
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 | Part 1 Dose Limiting Toxicity | From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide | |
| Primary | Part 2: Progression free survival per IMWG | From randomization up to 97 months. | |
| Primary | Part 2: Minimal Residual Disease negative CR rate | At 12 months after randomization | |
| Secondary | Overall Survival | From date of randomization up to 97 months | |
| Secondary | Overall minimal residual disease negative CR rate | From date of randomization up to 97 months | |
| Secondary | Sustained MRD negative CR rate (Part 2) | From date of randomization up to 97 months | |
| Secondary | Duration of minimal residual disease negative CR (Part 2) | From date of minimal residual disease negative CR status up to 97 months | |
| Secondary | PFS by investigator | From date of randomization up to 97 months | |
| Secondary | PFS2 by investigator (Part 2) | From the date of randomization up to 97 months | |
| Secondary | Objective Response Rate | From the date of randomization up to 97 months | |
| Secondary | Complete Response Rate | From the date of randomization up to 97 months | |
| Secondary | Time to Response | From the date of randomization to date of confirmed objective response up to 97 months | |
| Secondary | Duration of Response | From the date of confirmed objective response up to 97 months | |
| Secondary | Duration of Complete Response | From the date of confirmed complete response up to 97 months | |
| Secondary | Frequency of treatment-emergent adverse events | From the date of first dose of study intervention up to 97 months | |
| Secondary | Frequency of abnormal laboratory results | From the date of first dose of study intervention up to 97 months | |
| Secondary | Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations | From date of first dose of study intervention up to 97 months | Predose and post dose concentrations of elranatamab |
| Secondary | Incidence of Anti-Drug Antibody against elranatamab | From date of first dose of study intervention up to 97 months | Immunogenicity of elranatamab |
| Secondary | Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1) | From date of first dose of study intervention up to 97 months | Predose concentrations of daratumumab and lenalidomide |
| Secondary | Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2) | From date the informed consent is signed up to 97 months | 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 the 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.
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GET https://conductscience.org/api/trials/v1/NCT05623020/registered