Trial · NCT03651128
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Minimum of 5 years from randomization | Time from randomization to the first documentation of progressive disease based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma assessed by an independent response committee (IRC) or death due to any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | Minimum of 5 years from randomization | Time from randomization to time of death due to any cause |
| Secondary | Event-free Survival (EFS) | Minimum of 5 years from randomization | Time from randomization to the first documentation of progressive disease, first day when subject receives another anti-myeloma treatment or death due to any cause, whichever occurs first |
| Secondary | Overall Response Rate (ORR) | Minimum of 5 years from randomization | Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC |
| Secondary | Minimal Residual Disease (MRD) | Minimum of 5 years from randomization | Percentage of MRD evaluable subjects that are MRD negative (defined at a minimum of 1 in 10\^5 nucleated cells) using flow cytometry (EuroFlow) and next generation sequencing (NGS) |
| Secondary | Complete Response (CR) Rate | Minimum of 5 years from randomization | Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC |
| Secondary | Duration of Response (DOR) | Minimum of 5 years from randomization | Time from first documentation of response (PR or better) to first documentation of disease progression or death from any cause, whichever occurs first |
| Secondary | Time to Response (TTR) | Minimum of 5 years from randomization | TTR is calculated as the time from randomization to the initial documented response (PR or better) based on IMWG guideline for responders |
| Secondary | Adverse Events (AEs) | Minimum of 5 years from randomization | Number of participants with adverse events |
| Secondary | Pharmacokinetics- Cmax | Minimum 5 years after bb2121 infusion | Maximum peak in bb2121 chimeric antigen receptor (CAR) T cells |
| Secondary | Pharmacokinetics- tmax | Minimum 5 years after bb2121 infusion | Time to peak of bb2121 CAR T cells |
| Secondary | Pharmacokinetics- AUC | Minimum 5 years after bb2121 infusion | Area under the curve of CAR T cells |
| Secondary | Pharmacokinetics- t-last | Minimum 5 years after bb2121 infusion | Time to last measurable CAR T cells |
| Secondary | Pharmacokinetics- AUC0-28days | Minimum 5 years after bb2121 infusion | Area under the curve of CAR T cells from time zero to Day 28 |
| Secondary | Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30) | Minimum of 5 years from randomization | Questionnaire will be used as a measure of health-related quality of life |
| Secondary | Subject-reported outcomes as measured by EuroQoL Group European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L) Health Questionnaire | Minimum of 5 years from randomization | Is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal |
| Secondary | Subject-reported outcomes as measured by European Quality of Life Multiple Myeloma Module (EORTC-QLQ-MY20) | Minimum of 5 years from randomization | Is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality |
| Secondary | Time to next antimyeloma treatment | Minimum of 5 years from randomization | Time from randomization to first day when subject receives another anti-myeloma treatment |
| Secondary | Progression-free survival after next line therapy (PFS2) | Minimum of 5 years from randomization | Time from randomization to second objective disease progression or death from any cause, whichever is first |
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/NCT03651128/registered