Trial · NCT04813653
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment parameters. | follow-up 2 years post study | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment parameters. |
| Secondary | Overall response rate ORR | follow-up 2 years post study | Proportion of patients who achieve a best overall response of stringent complete response , complete response, very good partial response, or partial response as defined using the IMWG criteria |
| Secondary | Progression free survival PFS | follow-up 2 years post study | The time from first dose to the date of the first documented tumor progression or death due to any cause. PFS will be determined by an investigator, based upon laboratory data, as defined by the IMWG criteria |
| Secondary | Duration of Response DOR | follow-up 2 years post study | The time between the date of first response to the date of the first objectively documented tumor progression as assessed by study steering committee according to modified IMWG criteria or death due to any cause prior to subsequent anti-cancer therapy. |
| Secondary | Time to Response TTR | follow-up 2 years post study | The time from the first dose to the date of the first sCR, CR, VGPR, or PR. |
| Secondary | Depth of Best Response (DpR) | follow-up 2 years post study | According to IMWG criteria. |
| Secondary | Time to progression (TTP) | follow-up 2 years post study | Time from initiation of treatment to documented PD |
| Secondary | Overall Survival (OS) | follow-up 2 years post study | Time between the date of first dose and the date of death due to any cause |
| Secondary | Extramedullary progression | follow-up 2 years post study | Kaplan Meyer test will be applied to test for differences between the groups in Progression Free Survival |
| Secondary | Extramedullary progression | follow-up 2 years post study | Kaplan Meyer test will be applied to test for differences between the groups in Overall Survival |
| Secondary | Percentage of cyclosporine trough levels tests in acceptable range | follow-up 2 years post study | will be calculated for each patient. |
| Secondary | Mean % of levels in acceptable range will be calculated for the efficacy population. | follow-up 2 years post study |
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/NCT04813653/registered