Trial · NCT04096066
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 | Minimal residual disease (MRD) | 5 years | 1\. Minimal residual disease (MRD): unit of measure is not applicable, MRD is expressed as a pure number |
| Primary | Progression-free survival (PFS) | 5 years | 2\. Progression-free survival (PFS): unit of measure is not applicable, PFS is expressed as a pure number |
| Secondary | Rate of drug reduction or drug discontinuation | 5 years | Incidence of dose reduction and drug discontinuation in both treatment arms. |
| Secondary | Cardiovascular assessment | 5 years | Benefit of proper cardiovascular baseline assessment and monitoring during treatment in both treatment arms:to mitigate major cardiovascular adverse event incidence, to prolong duration of treatment, to improve efficacy. |
| Secondary | Rate of dose reduction, drug discontinuation and toxicities | 5 years | Safety as rate of dose reduction, drug discontinuation and toxicities |
| Secondary | Response rate | 5 years | Response rate will include complete response (CR), very good partial response (VGPR) and partial response (PR) using the International Response Criteria. Responders are defined as subjects with at least a PR. |
| Secondary | Progression-free survival 2 (PFS2) | 5 years | Time from randomization to objective tumor progression on next-line treatment or death from any cause. |
| Secondary | Time to progression (TTP) | 5 years | Time to progression will be measured from the date of randomization to the date of first observation of PD, or deaths related to PD. |
| Secondary | Duration of response (DOR) | 5 years | Time between first documentation of response and PD. Responders without disease progression will be censored either at the time of lost to FU, at the time of death due to other cause than PD, or at the end of the study. |
| Secondary | Overall survival (OS) | 5 years | Time between randomization and death. Subjects who die will be censored at time of death as an event, regardless cause of death. |
| Secondary | Time to next therapy (TNT) | 5 years | Time to next therapy will be measured from the date of randomization to the date of next anti-myeloma therapy. Death due to any cause before starting therapy will be considered an event. |
| Secondary | MRD negativity | 5 years | Correlation between MRD negativity and PFS, PFS2, TTP, TNT and OS |
| Secondary | Prognostic factors | 5 years | The following outcomes will be analysed in subgroups with different prognostic factors: * Progression-free survival (PFS), * Time to second disease progression (PFS2), * Time to progression (TTP), * Time to next therapy (TNT ), * Overall survival (OS) |
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/NCT04096066/registered