Trial · NCT04065789
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 | Proportion of patients who experience any AE incidence, grade > 2 drug-elicited toxicities, peripheral neuropathy events (Grade 2 or higher). | from screening through month 20 | Determined by adverse events, vital signs and clinical laboratory parameters in relation to study intervention. |
| Secondary | PFS | From treatment initiation to the earlier of disease progression or death due to any cause. Up to 2 years from last patient enrollment | Progression Free Survival (PFS) |
| Secondary | OS | From treatment initiation to date of death (whatever the cause). Up to 2 years from last patient enrollment | Overall Survival (OS) |
| Secondary | Overall response rate (ORR) | From Screening and up to 2 years from last patient enrollment | The fraction of patients who experience a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) per IMWG 2016 criteria. |
| Secondary | Duration of response (DOR) | From initiation of treatment and up to 2 years from last patient enrollment | Time of first evidence of PR or better to confirmation of PD or death due to any cause |
| Secondary | Time to progression (TTP) | From initiation of treatment and up to 2 years from last patient enrollment | From initiation of treatment to documented PD |
| Secondary | Clinical benefit response (CBR) rate | From initiation of treatment and up to 2 years from last patient enrollment | Defined as ORR or minimal response (MR) |
| Secondary | Disease control rate (DCR), | From initiation of treatment and up to 2 years from last patient enrollment | Defined as ORR or minimal response (MR) or stable disease (SD) lasting at least 8 weeks. |
| Secondary | Changes in Global Health Status and Quality of Life | From Screening and up to 2 years from last patient enrollment | The European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire Module QLQ-MY20 will be used to evaluate Global Health Status/QoL. Questionnaire Module QLQ-MY20 include 20 questions (items). Score scale is starting from minimum of 1 and up to a maximum of 4. Higher values represent a worse outcome.It is the complementary module of the QLQ-C30 which is specific for Multiple Myeloma patients. |
| Secondary | Changes in Global Health Status and Quality of Life | From Screening and up to 2 years from last patient enrollment | The European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire Module QLQ-C30 will be used to evaluate Global Health Status/QoL. Questionnaire Module QLQ-C30 include 30 questions score scale is starting from minimum of 1 and up to a maximum of 7. In most items (1-28) Higher values represent a worse outcome.The exceptions are the items contributing to the global health status / QoL - 2 items (29-30) In which Higher values represent a better outcome . It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. |
| Secondary | Changes in Frailty Status | From Screening and up to 4 month from last patient enrollment | Frailty assessment, for this study will be based only on 4 components : age, the Charlson Comorbidity Scoring System, the Katz Index of Independence in Activities of Daily Living and the Lawton Instrumental Activities of Daily Living Scale. All above 4 components are summed up and combined into one MM Frailty score - The score system (range 0-5, higher values represent a worse outcome), identifies 3 groups of patients: fit (score=0) intermediate-fitness (score=1) frail (score≥2) |
| Other | exploratory genomic profiling | From Screening and up to 2 years from last patient enrollment | mutational transcriptional and post translational changes associated with drug sensitivity and resistance, clonal evolution |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04065789/registered