Trial · NCT06464991
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal Residual Disease (MRD)-negative complete response (CR) rate at 12 months | 12 months (+/-3 months) post-randomization | The proportion of the first 126 randomized subjects who achieved a complete response (CR) or better, as assessed by Independent Review Committee (IRC), and were MRD-negative (assessed by next-generation flow cytometry \[NGF\] using the EuroFlow standard operating procedure) at 12 months (+/-3 months) post-randomization. |
| Primary | Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC) | up to 5 years from randomization | The time from randomization to the first IRC-assessed disease progression or death from any cause. |
| Secondary | Overall MRD negativity rate | up to 5 years from randomization | The proportion of subjects who achieve MRD negativity at any time after the date of randomization and before the initiation of subsequent therapy |
| Secondary | Duration of MRD negativity | up to 5 years from randomization | The time from first achievement of MRD negativity to the first subsequent positive MRD status |
| Secondary | Complete Response Rate（CRR） | up to 5 years from randomization | The proportion of subjects who achieve CR or better post-randomization among all randomized subjects |
| Secondary | Very good partial response or better response (≥VGPR) rate | up to 5 years from randomization | The proportion of subjects who achieve sCR, CR, or VGPR post-randomization among all randomized subjects |
| Secondary | Overall Response Rate（ORR） | up to 5 years from randomization | The proportion of subjects who achieve sCR, CR, VGPR, or PR post-randomization among all randomized subjects. |
| Secondary | Duration of Response (DOR) | up to 5 years from randomization | The time from the first date of initial documented response (≥PR) to the date of first disease progression or death from any cause, whichever occurs first, post-randomization |
| Secondary | Event-Free Survival (EFS) | up to 5 years from randomization | Time from randomization to the first occurrence of any of the following events: death, disease progression, initiation of a new anti-myeloma therapy, addition of other treatments, or occurrence of fatal or intolerable adverse effects |
| Secondary | Overall Survival（OS） | up to 5 years from randomization | Defined as the time from randomization to death due to any cause |
| Secondary | Time to Next Treatment（TTNT） | up to 5 years from randomization | Time from randomization to the initiation of a new subsequent anti-myeloma therapies |
| Secondary | Incidence of Adverse events | up to 5 years from randomization | Safety Endpoint |
| Secondary | Pharmacokinetic Endpoint-Cmax | up to 5 years from Eque-cel infusion | The maximum concentration (Cmax) of CAR VCN and BCMA CAR-T in peripheral blood after CAR-T infusion |
| Secondary | Pharmacokinetic Endpoint-Tmax | up to 5 years from Eque-cel infusion | the time for CAR VCN and BCMA CAR-T to reach the maximum concentration (Tmax) after CAR-T infusion |
| Secondary | Pharmacokinetic Endpoint-AUC | up to 5 years from Eque-cel infusion | Area under the curve of 29, 85, 169 days and the last time point of PK detection (AUC0-29d, AUC0-85d, AUC0-169d, AUC0-last) for CAR VCN; Area under the curve of 29 days (AUC0-29) for BCMA CAR-T. |
| Secondary | Pharmacodynamic Endpoint | up to 5 years from Eque-cel infusion | The concentration of soluble BCMA in peripheral blood of experimental group at each time point |
| Secondary | Health Related Quality of Life Endpoint | up to 5 years from randomization | Symptoms, function, and overall HRQoL were collected using the validated Patient-Reported Outcomes (PRO) questionnaire |
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.
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