Trial · NCT04923893
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to 4 years and 5 months | Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. |
| Secondary | Sustained Minimal Residual Disease (MRD) Negative CR | Up to 12 years and 5 months | Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10\^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status. |
| Secondary | MRD Negative CR at 9 Months | 9 months | MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date. |
| Secondary | Overall MRD Negative CR | Up to 12 years and 5 months | Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy. |
| Secondary | Overall Survival (OS) | Up to 12 years and 5 months | Overall survival is measured from the date of randomization to the date of the participant's death. |
| Secondary | Complete Response or Better | Up to 12 years and 5 months | CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria. |
| Secondary | Time to Subsequent Anti-myeloma Therapy | Up to 12 years and 5 months | Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy. |
| Secondary | Progression Free Survival on Next-line Therapy (PFS2) | Up to 12 years and 5 months | PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. |
| Secondary | Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs | Up to 12 years and 5 months | Number of participants with AEs, abnormalities in laboratory parameters (complete blood count \[CBC\] with differential, coagulation, chimeric antigen receptor T cell \[CAR-T\] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported. |
| Secondary | Arm B: Systemic Cytokine Concentrations | Up to Day 112 | Serum or plasma proteomic profiling of cytokines (such as interleukin \[IL\] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment. |
| Secondary | Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers | Up to 12 years and 5 months | CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response. |
| Secondary | Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA) | Up to 1 year | Levels of soluble BCMA will be reported. |
| Secondary | Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence | Up to 12 years and 5 months | Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported. |
| Secondary | Arm B: Number of Participants with Anti-cilta-cel Antibodies | Up to 12 years and 5 months | Number of participants with anti-cilta-cel antibodies will be reported. |
| Secondary | Arm B: Number of Participants with Presence of Replication Competent Lentivirus | Up to 12 years and 5 months | Number of participants with presence of replication competent lentivirus will be reported. |
| Secondary | Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score | Baseline up to 12 years and 5 months | The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score | Baseline up to 12 years and 5 months | The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact. |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score | Baseline up to 12 years and 5 months | The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score | Baseline up to 12 years and 5 months | The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe). |
| Secondary | Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items | Up to 161 days | The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact. |
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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