Trial · NCT06158841
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 Approximately 5 Years | PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first. |
| Primary | Objective Response Rate (ORR) | Up to Approximately 5 Years | ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment. |
| Secondary | Overall Survival (OS) | Up to Approximately 5 Years | OS is defined as the duration from the date of randomization to the date of the participant's death. |
| Secondary | Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR) | Up to Approximately 5 Years | The rate of \>= VGPR is defined as the proportion of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new myeloma therapy. |
| Secondary | Change in Rate of CR or Better (>=CR) | Up to Approximately 5 Years | \>=CR is defined as the percentage of participants who achieve confirmed CR + sCR or per IRC assessment. |
| Secondary | Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR | Up to Approximately 5 Years | MRD negativity with \>= CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by next-generation sequencing (NGS) Adaptive Clonoseq at 10\^-5 threshold. |
| Secondary | Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20) | Up to 6 Months | The disease symptoms domain of EORTC QLQ-MY20 is a 6-item questionnaire to assess the physical function of the participant, with a higher score indicating a higher level of symptoms. |
| Secondary | Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) | Up to 6 Months | The physical functioning domain of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indicating worse functioning. |
| Secondary | Time to Response (TTR) | Up to Approximately 5 Years | TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by IRC. |
| Secondary | Duration of Response (DOR) | Up to Approximately 5 Years | DOR is defined as the number of days from the day the response criteria are met to the date that disease progression as determined by the IRC. |
| Secondary | Time-to-Progression (TTP) | Up to Approximately 5 Years | TTP is defined as the number of days from the date of first dose to the date of earliest disease progression as determined by the IRC. |
| Secondary | Time to Next Anti-lymphoma Therapy (TTNT) | Up to Approximately 5 Years | TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy. |
| Secondary | Number of Participants with Event-free Survival (EFS) | Up to Approximately 5 Years | EFS is defined as the time from randomization until adverse event determined by the IRC, or death, whichever occurs first. |
| Secondary | Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) | Up to Approximately 6 Months | The PROMIS Fatigue SF7a is a 7-item short form that assesses the impact and experience of fatigue in the past 7 days. For each item, 5-point rating scales are used to measure frequency ("Never," "Rarely," "Sometimes," "Often," or "Always") with a higher score indicating a greater impact. |
| Secondary | Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to Approximately 6 Months | The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items are scored from 0 to 4 to evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence. |
| Secondary | Change from Baseline in Remaining Items in the EORTC QLQ-C30 | Up to Approximately 6 Months | The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. |
| Secondary | Change from Baseline in Remaining Items in the EORTC QLQ-MY20 | Up to Approximately 6 Months | The EORTC QLQ-MY20 consists of four scales: two symptom scales (Disease Symptoms \[6 items\] and Side Effects of Treatment \[10 items\]), one function scale (Future Perspective \[3 items\]), and one single item (Body Image). Each item has four response options: "Not at all," "A little," "Quite a bit," or "Very much". All scores are then linearly transformed to a 0 to 100 scale. A higher score on the symptom scales indicates a higher level of symptoms, whereas higher scores on future perspective and body image indicate good functioning or support. |
| Secondary | Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L) | Up to Approximately 6 Months | The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state. |
| Secondary | Change from Baseline in Patient Global Impression of Severity (PGIS) | Up to Approximately 6 Months | The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity. |
| Secondary | Change from Baseline in Patient Global Impression of Change (PGIC) | Up to Approximately 6 Months | The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT06158841/registered