Trial · NCT07045909
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of all adverse events (AEs) | 3 years | To characterize the safety of anitocabtagene autoleucel following induction therapy (incidence of treatment-emergent adverse events). |
| Primary | Undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10-5) at 12 months (+/- 3 months) after enrollment. | 12 months | To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry (NGF, with a sensitivity level of 10-6). |
| Secondary | Undetectable minimal residual disease (MRD) negative CR rate (minimum 10-5) at 2, 6, 12, 18 and 24 months after CAR T infusion and sustained undetectable minimal residual disease (uMRD) annually. | 2 years | To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry. |
| Secondary | Stringent complete response (sCR) or complete response (CR) rate, as assessed by investigators according to the International Myeloma Working Group (IMWG) criteria. | 6 months | CR measured by cytomorphplogy and flow cytometry. |
| Secondary | Overall MRD negativity (minimum 10e-5) | 3 years | MRD measured by Next Generation Flow Cytometry. |
| Secondary | Rate of conversion from undetectable to detectable MRD as well as biochemical progression rate. | 3 years | MRD measured by Next Generation Flow Cytometry. Biochemical progression by measuring serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms. |
| Secondary | Time to biochemical progression (including the conversion from undetectable to detectable MRD). | 3 years | MRD measured by Next Generation Flow Cytometry. Serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms. |
| Secondary | Undetectable MRD at 10e-6 (0.0001%) | 3 years | MRD measured by Next Generation Flow Cytometry. Undetectable MRD at 10e-6 (10 elevated to -6, which is the same as 0.0001%) means no presence of multiple myloma cells within 1,000,000 cells analyzed by flow cytometry |
| Secondary | Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) criteria | 3 years | ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, VGPR, or PR) per IMWG criteria. |
| Secondary | Duration of Response (DoR) | 3 years | DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per IMWG criteria and is defined as the time from first overall response to disease progression per IMWG criteria, or death from any cause, whichever occurs first. |
| Secondary | Progression Free Survival (PFS) | 3 years | PFS is defined as the time from enrollment to the first documented disease progression per IMWG criteria as determined by investigator assessed or death due to any cause, whichever occurs first. |
| Secondary | Overall survival (OS) | 3 years | OS is defined as the time from enrollment to the date of death from any cause. |
| Secondary | Overall rate of "imaging plus MRD negative" (using PET/CT per International Myeloma Working Group [IMWG] criteria) | 3 years | Measured by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan using the Deauville score. The Deauville score is a 5-point grading system used on FDG PET/CT imaging to assess treatment response. It is based on comparing FDG uptake in lesions with uptake in the liver and mediastinum. The Deauville score values are: 1. No FDG uptake above background. 2. Uptake less than the liver. 3. Uptake equal to the liver. 4. Uptake moderately greater than the liver. 5. Uptake markedly greater than the liver, typically 2-3 times greater. |
| Secondary | Expansion and persistence of anitocabtagene autoleucel in peripheral blood | 2.5 years | Measured by Next Generation Flow Cytometry. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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