Trial · NCT06187441
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare Event-Free Survival (EFS) | Approximately up to 57 (EFS) months after randomization of the first patient | To compare Event-Free Survival (EFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD |
| Primary | Compare Progression Free Survival (PFS) | Approximately up to 69 (PFS) months after randomization of the first patient | To compare Progression Free Survival (PFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD |
| Secondary | Compare adverse event burden | Approximately up to 69 months after randomization of the first patient | To compare adverse event (AE) burden between arms |
| Secondary | Compare patient-reported outcome measures (PROMs) | Approximately up to 69 months after randomization of the first patient | To compare PROMs between arms via validated questionnaires such as Impact of Cancer version 2 Cancer Worry scale |
| Secondary | Compare cost-effectiveness between arms | Approximately up to 69 months after randomization of the first patient | To compare cost-effectiveness between arms |
| Secondary | Determine the length of the treatment-free interval | Approximately up to 69 months after randomization of the first patient | To determine the length of the treatment-free interval (TFI) in arm B |
| Secondary | Determine time to (maximal) response response | Approximately up to 69 months after randomization of the first patient | To determine time to (maximal) response after restart of Dara-Rd in arm B. |
| Secondary | Compare time to next treatment | Approximately up to 69 months after randomization of the first patient | To compare time to next treatment (TTNT) between arms |
| Secondary | Compare time from randomization to progression on second-line therapy | Approximately up to 69 months after randomization of the first patient | To compare time from randomization to progression on second-line therapy (PFS2) between arms. |
| Secondary | Compare Overall Survival | Approximately up to 69 months after randomization of the last patient | To compare Overall Survival (OS) between arms. |
| Secondary | Compare the discontinuation rate | Approximately up to 69 months after randomization of the first patient | To compare the discontinuation rate and the reasons for discontinuation between arms. |
| Secondary | Evaluate cumulative doses | Approximately up to 69 months after randomization of the first patient | To evaluate cumulative dose of daratumumab, lenalidomide and dexamethasone in both arms. |
| Secondary | Compare dose reductions | Approximately up to 69 months after randomization of the first patient | To compare dose reductions of daratumumab, lenalidomide and dexamethasone between arms. |
| Secondary | Compare toxicity | Approximately up to 69 months after randomization of the first patient | To compare toxicity according to CTCAE v5 between arms |
| Secondary | Compare Quality of Life | Approximately up to 69 months after randomization of the first patient | To compare Quality of Life between arms via validated questionnaires such as QLQ-C30, MY20, EQ-5D-5L |
| Secondary | Compare relative dose intensity | Approximately up to 69 months after randomization of the first patient | To compare relative dose intensity (RDI) of daratumumab, lenalidomide and dexamethasone between arms. |
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/NCT06187441/registered