Trial · NCT07903272
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to approximately 10 years | PFS is defined as the duration from the date of randomization to either confirmed progressive disease (PD) or death, whichever occurs first. PD will be determined according to international myeloma working group (IMWG) response criteria. |
| Primary | Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) | Up to approximately 12 months | 12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months (plus minus \[+-\] 3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including autologous stem cell transplantation \[ASCT\]). |
| Secondary | Overall Survival (OS) | Up to approximately 10 years | OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive. |
| Secondary | Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR | Up to 5 years | 24-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS, for at least 24 months without any examination showing MRD positive status in between, and prior to PD or subsequent antimyeloma therapy (including ASCT). |
| Secondary | Percentage of Participants with Very Good Partial Response (VGPR) or Better | Up to 5 years | VGPR or better is defined as participants who achieve VGPR, CR, or stringent complete response (sCR) prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention. |
| Secondary | Percentage of Participants with Complete Response (CR) or Better | Up to 5 years | CR or better is defined as participants who achieve CR or sCR prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention. |
| Secondary | Percentage of Participants with Overall Response (ORR) | Up to 5 years | Overall response rate is defined as percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention. |
| Secondary | Percentage of Participants with Overall MRD-Negative CR | Up to 5 years | Overall MRD-negative CR is defined as participants who achieve MRD negative status, as determined by NGS, at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better. |
| Secondary | Percentage of Participants Achieving 12-Month Sustained MRD-Negative CR | Up to 5 years | 12-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS, for at least 12 months without any examination showing MRD positive status in between, and prior to PD or subsequent antimyeloma therapy (including ASCT). |
| Secondary | Progression-Free Survival 2 (PFS2) | Up to approximately 10 years | 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, on the first subsequent line of antimyeloma therapy or death from any cause, whichever occurs first. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity | Up to approximately 10 years | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy will be considered treatment-related regardless of the start date of the event. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event. |
| Secondary | Number of Participants With Adverse Events by Severity | Up to approximately 10 years | An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. |
| Secondary | Number of Participants with Significant Abnormalities in Laboratory Parameters | Up to approximately 10 years | Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported. |
| Secondary | Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores | From Baseline up to approximately 10 years | The MySIm-Q is a disease-specific patient reported outcome (PRO) assessment with established content validity for participants with newly diagnosed multiple myeloma (NDMM). It is included to be complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact. |
| Secondary | Change from Baseline in HRQoL, Symptoms and Functioning Using the EORTC QLQ C30 Scale Scores | From Baseline up to approximately 10 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); 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea); and a single impact item (financial difficulties). 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 HRQoL, Symptoms and Functioning Using European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores | From Baseline up to approximately 10 years | The EQ-5D-5L is a self-administered, generic health status measure, consisting of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), each with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). Higher scores indicate worse HRQoL. |
| Secondary | Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores | Up to approximately 10 years | Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact. |
| Secondary | Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores | Up to approximately 10 years | Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 scale scores will be reported. 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 | Time to Worsening in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores | Up to approximately 10 years | Time to worsening in HRQoL, symptoms and functioning using the EQ-5D-5L scale scores will be reported. The EQ-5D-5L descriptive system covers 5 dimensions of health each with 5 levels of severity with higher scores indicating worse HRQoL. |
| Secondary | Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores | Up to approximately 10 years | Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning using MySIm-Q scale score will be reported. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate 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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