Trial · NCT02252172
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years) | Intent-to-treat (ITT) population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Better | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Very Good Partial Response (VGPR) or Better | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Negative Minimal Residual Disease (MRD) | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stringent Complete Response (sCR) | From randomization (Day -3) up to 6.6 years | Intent-to-treat (ITT) population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization (Day -3) up to 8.7 years | ITT population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Time to Disease Progression (TTP) | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Time to Response | From randomization (Day -3) up to 6.6 years | Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints. | Months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | From randomization (Day -3) up to 6.6 years | Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (Overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Time to Subsequent Anti-myeloma Treatment | From randomization (Day -3) up to 8.7 years | Intent-to-treat (ITT) population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Progression-free Survival on Next Line of Therapy (PFS2) | From randomization (Day -3) up to 6.6 years | Intent-to-treat (ITT) population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score | Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days) | ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) | Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days) | ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' signifies number of participants analyzed at specified timepoints. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score | Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days) | ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' signifies number of participants analyzed at specified timepoints. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-group Analysis: Progression-free Survival (PFS) | From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 6.6 years). | Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Sub-group Analysis: Overall Response Rate (ORR) | From randomization (Day -3) up to 6.6 years | Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
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/NCT02252172/outcomes