Trial · NCT06895512
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 | IRC-assessed Week 24 rate of very good partial response (VGPR) or better | 24 weeks | the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization. |
| Secondary | Investigator-assessed Week 24 rate of VGPR or better | 24 weeks | the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization |
| Secondary | IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better | 12,36,48 weeks | percentage of patients achieving VGPR or CR (including sCR) until Week 12, 36 and 48 after the date of randomization |
| Secondary | IRC- and investigator-assessed partial response (PR) rate | 48 weeks | the percentage of patients achieving PR at any time point after the date of randomization |
| Secondary | IRC- and investigator-assessed complete response (CR) rate | 48 weeks | the percentage of patients achieving CR at any time point after the date of randomization. |
| Secondary | IRC- and investigator-assessed stringent complete response (sCR) rate | 48 weeks | percentage of patients achieving sCR at any time point after the date of randomization |
| Secondary | IRC- and investigator-assessed complete response (CR) or better rate | 48 weeks | the percentage of patients achieving CR or sCR at any time point after the date of randomization. |
| Secondary | IRC- and investigator-assessed overall response rate | 48 weeks | the percentage of patients who achieve PR or better after the date of randomization. |
| Secondary | IRC- and investigator-assessed time to response (TTR) | 48 weeks | the time from the date of randomization to the date of initial documentation of a response (PR or better) for patient who had achieved a response of PR or better |
| Secondary | IRC- and investigator-assessed duration of response (DOR) | 48 weeks | the date of initial documentation of a response (PR or better) to either progressive disease according the IMWG criteria, or death, whichever occurs first |
| Secondary | IRC- and investigator-assessed progression free survival (PFS) | 48 weeks | the duration from the date of randomization to either progressive disease, according to the IMWG response criteria, or death, whichever occurs first. |
| Secondary | Minimal residual disease (MRD) negative rate | 48 weeks | the percentage of patients who achieve negative MRD at least once during the confirmed complete response (CR) or better according to the IMWG response criteria. |
| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30). | 48 weeks | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30).Minimum and maximum values is according to the items, the score range of item 1-28 is 1-4, the score range of item 29-30 is 1-7. The higher the overall score is, the better the overall quality of life is. |
| Secondary | EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire. | 48 weeks | EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.The description of health status is divided into five levels.Health Status Index range is -0.59-1.00, VAS range is 0-100.The higher the Health Status Index and VAS score are, the better the health condition is; the lower the dimension description score is, the fewer problems there are. |
| Secondary | Incidence and severity of adverse events (AEs) | 52 weeks | severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0, vital signs and clinical laboratory test results |
| Secondary | Time to reach maximum serum drug concentration at steady state (Tmax, ss) | 48 weeks | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Secondary | Time to reach maximum serum drug concentration(Tmax) | 48 weeks | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Secondary | Immunogenicity | 48 weeks | Incidence of ADA and/or NAb for HLX15-IV and DARZALEX |
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/NCT06895512/registered