Trial · NCT05979363
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability | Up to 2 year | The incidence of treatment-emergent adverse events (TEAEs) |
| Primary | MRD-negative rate | within 1 week after consolidation treatment | achieving MRD-negative, as determined by NGF after consolidation treatment |
| Secondary | Complete response rate (CRR) | within 1 week after induction therapy, 1 month after the CAR-T cell transfusion, within 1 week after consolidation therapy | CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria |
| Secondary | Progression free survival (PFS) | Up to 2 year | Progression free survival is defined as the time from the date of enrollment to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first |
| Secondary | Overall Survival (OS) | Up to 5 year | Overall survival is measured from the date of enrollment to the date of the participant's death. |
| Secondary | Duration of Remission(DOR) | Up to 2 year | Duration of response is defined as the time from the first documented partial response (PR) or better to disease progression or death from any cause, whichever occurs first. |
| Other | The duration of CART cell in vivo | Up to 1 year | The copies of BCMA-CART DNA in peripheral blood with qPCR method |
| Other | Change from Baseline in Physical status assessed by International Myeloma Working Group Comprehensive Geriatric Assessment (IMWG-CGA) scores | Baseline up to 5 years | The IMWG-CGA was calculated by combining age, activities of daily living (ADL), instrumental ADL (IADL), and Charlson Comorbidity Index (CCI), which ranges from 0 to 5 with higher scores indicating worse physical condition and greater weakness. |
| Other | Change from Baseline in Physical status assessed by activities of daily living (ADL) scores | Baseline up to 5 years | The ADL includes 4 items (transfer, bed mobility, toileting, and eating), which range from 0 to 6 scores. A higher score represents worse physical condition and greater weakness. |
| Other | Change from Baseline in Physical status assessed by instrumental activities of daily living (IADL) scores | Baseline up to 5 years | The IADL includes 5 items (cooking, cleaning, transportation, laundry, and managing finances), which range from 0 to 8 scores. A higher score represents worse physical condition and greater weakness. |
| Other | Change from Baseline in Physical status assessed by Charlson Comorbidity Index (CCI) | Baseline up to 5 years | The CCI estimates the number and the severity of comorbidities, including nineteen diseases with a score varying from 1 to 6 for each of them in accordance to their severity. The score can range from 0 to 37. A higher score represents more severe comorbidities. |
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/NCT05979363/registered