Trial · NCT04009109
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Impact of Study Treatment on Progression Free Survival (PFS) | 5 Years | Time interval between registration and progression or death. |
| Secondary | Minimal Residual Disease (MRD) | 5 Years | Minimal residual disease (MRD) negativity in the blood and marrow will be determined using the IMWG criteria. |
| Secondary | Toxicity Profile of Treatment Arm Based on Patient Response | 5 Years | Evaluation of incidence and severity of adverse events by summaries of toxicity data/contingency tables. |
| Secondary | Overall Response Rate (ORR) | 5 Years | Proportion of patients with reduction in tumor burden of a predefined amount. |
| Secondary | Overall Survival (OS) | 5 Years | Time from registration to death due to any cause. |
| Secondary | Quality of Life with the EQ 5D 5L Questionnaire | 5 Years | Consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five 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 patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
| Secondary | Quality of Life with the EORTC QLQ-MY20 Questionnaire | 5 Years | The EORTC QLQ-MY20 module was developed as an addition to the QLQ-C30 for use specifically in MM. It has 4 domains (disease symptoms, side effects of treatment, body image, future perspectives). Scores range from 0 to 100; good HRQoL is indicated by high scores for future perspective and body image, and low scores for disease symptoms and side effects of treatment. |
| Secondary | Quality of Life with the EORTC QLQ-C30 Questionnaire | 5 Years | The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Rate of Adherence to Lenalidomide and Ixazomib | 5 Years | All patients who have begun treatment will be included in the estimate of adherence rate to lenalidomide and the estimate of the adherence rate to ixazomib. |
| Secondary | Alliance Geriatric Assessment with IMWG Fragility Score | 5 Years | To describe functional status, comorbidity, psychological state, social activity, social support, chemotherapy toxicity, and nutrition using the geriatric assessment tool. |
| Other | Changes in Body Composition After Induction Therapy | 5 Years | Fat and lean mass will be measured using dual energy X-ray absorptiometry (DXA previously DEXA). |
| Other | Circulating MM cells and circulating DNA through DNA sequencing | 5 Years | Blood samples will be collected to study DNA of normal and any potential tumor cells in blood. Further assessment of the genes, the RNA, and the proteins that are found in MM cells as well as in normal, noncancerous cells will be done. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04009109/registered