Trial · NCT05552222
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) | From randomization to the date of disease progression or death (Up to 09 years) | PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria. |
| Primary | 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) | At Month 12 | 12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria. |
| Secondary | Very Good Partial Response (VGPR) or Better | From randomization up to 09 years | VGPR or better is defined as the percentage of participants achieving VGPR and CR (including stringent complete response \[sCR\]) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Secondary | Complete Response (CR) or Better | From randomization up to 09 years | CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Secondary | Sustained Minimal Residual disease (MRD)-negative Complete Response (CR) | From randomization up to 09 years | Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by NGS with sensitivity of 10\^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between. |
| Secondary | MRD-negative CR | From randomization up to 09 years | MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10\^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better. |
| Secondary | Progression Free Survival on Next-line Therapy (PFS2) | From randomization up to 09 years | PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | From randomization to the date of death (up to 09 years) | OS is defined as the time from the date of randomization to the date of death due to any cause. |
| Secondary | Number of Participants with Adverse Events (AEs) by Severity | From randomization up to 09 years | An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. |
| Secondary | Number of Participants with Abnormalities in Laboratory Parameters | From randomization up to 09 years | Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported. |
| Secondary | Number of Participants with Abnormalities in Vital Signs | From randomization up to 09 years | Number of participants with abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported. |
| Secondary | Number of Participants with Abnormalities in Physical Examination | From randomization up to 09 years | Number of participants with abnormalities in physical examination will be reported. |
| Secondary | Number of Participants with Abnormalities in Electrocardiogram (ECG) | From randomization up to 09 years | Number of participants with abnormalities in ECG will be reported. |
| Secondary | Serum Concentrations of Teclistamab and Talquetamab | From randomization up to 09 years | Serum samples will be analyzed to determine concentrations of teclistamab and talquetamab using validated, specific, and sensitive methods. |
| Secondary | Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab | From randomization up to 09 years | Number of participants with ADAs to teclistamab and talquetamab will be reported. |
| Secondary | Change from Baseline in Symptoms, Functioning, and 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) | From baseline up to 9 years | The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days) | The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact. |
| Secondary | Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) | From baseline up to 9 years | The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Secondary | Time to Sustained Worsening in Symptoms, Functioning, and HRQoL | From randomization up to 09 years | Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. |
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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