Trial · NCT07107529
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) per IMWG criteria | 18 months | defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria. |
| Secondary | Overall Survival (OS) | 9 years | Measured from the date of from randomization to the date the subject's death. |
| Secondary | Minimal Residual Disease (MRD) negativity rate | 18 months | Minimal Residual Disease (MRD) negative as determined by NGF at 10\^-5 sensitivity level per International Myeloma Working Group (IMWG) criteria. |
| Secondary | Minimal Residual Disease (MRD) negative CR | 18 months | Minimal Residual Disease (MRD) negative Complete Remission (CR) at the end of fixed treatment duration status as determined by NGF at 10\^-5 sensitivity level and who also achieve CR or better per International Myeloma Working Group (IMWG) criteria. |
| Secondary | Sustained Minimal Residual Disease (MRD) negative CR | 9 years | Sustained MRD-negative CR is defined as patients with CR or better who sustain MRD-negative status, as determined NGF at 10\^-5. |
| Secondary | IMWG best response | 18 months | To evaluate the proportion of IMWG best response achieved by a patient during the study. Subject will be classified as Not Evaluable (NE) if they will not have any evaluable response assessment. |
| Secondary | Time to response | 9 years | Time from the date of randomization to the date of first documentation of a confirmed response (partial response) as per IMWG response criteria, for patients who have PR or better as their best response. |
| Secondary | Time to best response | 9 years | Time from the date of randomization to the date of first best response as per IMWG response criteria. |
| Secondary | Event free survival (EFS) | 9 years | Time from the date of randomization to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause or treatment discontinuation due to toxicity, whichever occurs first. |
| Secondary | Progression Free Survival 2 (PFS2) | 9 years | Time from the randomization date to the date of event, which is defined as death from any cause or progression disease on the next line of therapy, whichever occurs first. |
| Secondary | Time to Next Treatment (TNT) | 9 years | Time from the randomization date to the date of event, which is defined as the start of the next line of therapy or death from any cause, whichever occurs first. |
| Secondary | Adverse Events | 9 years | Incidence and severity of Adverse Events during initial therapy, Treatment-Free-Interval (TFI) and after restarting therapy. |
| Secondary | Discontinuation | 9 years | Discontinuation rate and cause due to treatment related toxicity during initial therapy and after restarting therapy, including overall discontinuation rate, discontinuation rate of daratumumab, teclistamab and talquetamab. |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score | Up to 9 years | The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. 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 European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Myeloma 20 (EORTC-MY-20) Scale Score | Up to 9 years | The EORTC-QLQ-MY20 is a specialised tool designed to assess the quality of life in myeloma patients. Scores are linearly transformed to a 0-100 scale, where higher scores on the symptom scales indicate worse outcomes. |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by Activities of Daily Living (ADL) questionnaire | Up to 9 years | The ADL questionnaire assesses functional status by measuring independence in six daily activities. The ADL scale is scored from 0 to 8, where higher scores indicate greater independence with daily activities. |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by Instrumental Activities of Daily Living (IADL) questionnaire | Up to 9 years | The IADL assesses instrumental activities of daily living, including telephone use, laundry, shopping, food preparation, and mode of transportation. The IADL scale is scored from 0 to 8, with higher scores indicating greater independence. |
| Secondary | Change from Baseline in Health-Related Quality of Life as Assessed by Scale of Subjective Total Taste Acuity (STTA) | Up to 9 years | The STTA scale assesses the taste acuity during treatment. The STTA scale is scored from 0 to 4, where 4 indicates almost complete loss of taste acuity. |
| Secondary | Change from Baseline in the geriatric assessment as Assessed by Geriatric Depression Scale (GDS) | Up to 9 years | The GDS scale assesses the depressive symptoms in frail elderly patients. The GDS scale is scored from 0 to 15. Score 1 point for each bolded answer. A score of 5 or more suggests depression. |
| Secondary | Change from Baseline in the geriatric assessment as Assessed by Mini Nutritional Assessment (MNA) questionnaire | Up to 9 years | The MNA is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The MNA scale is scored from 1 to 30. A higher score represents good nutrition, a score less then 17 represents malnutrition. |
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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GET https://conductscience.org/api/trials/v1/NCT07107529/registered