Trial · NCT04855136
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 | Does Limiting Toxicity (DLT) rates _Phase 1 | Up to 28 days from start of the combination therapy | Percentage of participants experiencing DLTs |
| Primary | Complete Response Rate (CRR)_ Phase 2 | Up to 24 months | Proportion of participants who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by investigator's review |
| Secondary | Incidence of Adverse Event (AEs) | Up to 24 months after the last participant received any study treatment | An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. |
| Secondary | Overall Response Rate (ORR) | Up to 24 months after the last participant received any study treatment in the respective cohort | Proportion of participants who achieved PR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed investigator's review |
| Secondary | Progression-free Survival (PFS) | Up to 24 months after the last participant received any study treatment in the respective cohort | Time from first study treatment (whichever is given earlier) start date to the date of either first observation of progressive disease or death due to any cause |
| Secondary | Overall Survival (OS) | Up to 24 months after the last participant received any study treatment in the respective cohort | Time from first study treatment (whichever is given earlier) start date to death due to any cause |
| Secondary | Time to response (TTR) | Up to 24 months after the last participant received any study treatment in the respective cohort | Time from first study treatment start date to the first date of documented response (PR or better) |
| Secondary | Duration of Response (DoR) | Up to 24 months after the last participant received any study treatment in the respective cohort | Time from first documentation of response (PR or better) to first documentation of PD or death due to any cause |
| Secondary | Time to next antimyeloma treatment (TTNT) | Up to 24 months after the last participant received any study treatment in the respective cohort | Time from first study treatment (whichever is given earlier) start date to first day when participant receives another antimyeloma treatment |
| Secondary | Progression-free survival after next antimyeloma therapy (PFS2) | Up to 24 months after the last participant received any study treatment in the respective cohort | Time from first study treatment (whichever is given earlier) start date to documentation of PD on the next-line treatment or death from any cause, whichever is first. |
| Secondary | Feasibility of maintenance therapy in combination with bb2121 | Up to 4 months after bb2121 infusion in the respective cohort | Cumulative incidence of the maintenance therapy starting from bb2121 infusion with death as the competing risk |
| Secondary | Pharmacokinetics - Cmax_Phase 1 and 2 | Up to 24 months after the last participant received any study treatment in the respective cohort | Maximum transgene level |
| Secondary | Pharmacokinetics - Tmax_Phase 1 and 2 | Up to 24 months after the last participant received any study treatment in the respective cohort | Time to maximum observed transgene level |
| Secondary | Pharmacokinetics - AUC_Phase 1 and 2 | Up to 24 months after the last participant received any study treatment in the respective cohort | Area under the curve of transgene level |
| Secondary | Pharmacokinetics - AUC0-28days _Phase 1 and 2 | Up to 24 months after the last participant received any study treatment in the respective cohort | Area under the curve of transgene level from time 0 to 28 days |
| Secondary | Pharmacokinetics - Tlast _Phase 1 and 2 | Up to 24 months after the last participant received any study treatment in the respective cohort | Time of last measurable transgene level |
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/NCT04855136/registered