Trial · NCT04566328
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Consolidation overall survival | Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years | Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone \[Btz-DRd\] then daratumumab, lenalidomide and dexamethasone \[DRd\] then daratumumab and lenalidomide \[DR\]). |
| Secondary | Consolidation progression-free survival | Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years | Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events. |
| Secondary | Incidence of adverse events | During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). | |
| Secondary | Incidence of grade 3 or higher non-hematologic adverse events | During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). | |
| Secondary | Incidence of grade 3 or higher adverse events | During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). | |
| Secondary | Best response | During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). | |
| Secondary | FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) | From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks | Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance. |
| Other | Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) | From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) | Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome. |
| Other | Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) | From the end of induction through 1 year of maintenance, 21 weeks | The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome. |
| Other | Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) | Up to 15 years | Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement. |
| Other | Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) | Up to 15 years | |
| Other | PRO compliance rate | Up to 15 years | Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation). |
| Other | PRO completion rate | Up to 15 years | Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point. |
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/NCT04566328/registered