Trial · NCT02761187
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Co-morbidities | Baseline up to 5 years | Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use. |
| Primary | Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM) | At Baseline | Participants diagnosed with NDMM and R/RMM were determined at the start of the study. |
| Primary | Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study | Baseline up to 5 years | |
| Primary | Sites of Disease Diagnosed With ND MM and R/R MM | Baseline up to 5 years | |
| Primary | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | At Baseline | ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry. |
| Primary | Number of Participants With Myeloma Frailty Index | At Baseline | Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry. |
| Primary | Number of Participants Evaluated for Minimal Residual Disease (MRD) | Baseline up to 5 years | |
| Primary | Number of Participants Evaluated for Gene Expression Profiling (GEP) | Baseline up to 5 years | |
| Primary | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | At Baseline | FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\]. |
| Primary | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | At Baseline | ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L). |
| Primary | Duration of Treatment for Participants With and Without Stem Cell Transplant | Baseline up to 5 years | Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. |
| Primary | Overall Survival (OS) | Baseline up to 5 years | Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis. |
| Primary | Disease Progression Status on Each Regimen | Baseline up to 5 years | Disease progression status was assessed by physician interpretation of IMWG Response criteria. |
| Primary | Response to Each Regimen | Baseline up to 5 years | |
| Primary | Time to Next Therapy | Baseline up to 5 years | The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis. |
| Primary | Number of Participants With Stem Cell Transplant | Baseline up to 5 years | |
| Primary | Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants | Baseline up to 5 years | The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL. |
| Secondary | Number of Participants Receiving Different Treatment Combinations | Baseline up to 5 years | |
| Secondary | Number of Treatment Sequencing | Baseline up to 5 years | Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy. |
| Secondary | Number of Participants in the Treatment Rechallenge | Baseline up to 5 years |
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/NCT02761187/registered