Trial · NCT02252172
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to \[\>=\] 0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \[\>\]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to Plasma cell (PC) proliferative disorder. |
| Secondary | Percentage of Participants With Complete Response (CR) or Better | From randomization (Day -3) up to 6.6 years | Percentage of participants with a CR or better (CR or stringent complete response \[sCR\]) based on computerized algorithm as per IMWG criteria was reported. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio was required. sCR was defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence, 2-4 color flow cytometry (FC). |
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better | From randomization (Day -3) up to 6.6 years | VGPR or better rate was defined as the percentage of participants who achieved VGPR or better (VGPR, CR or sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \< 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. |
| Secondary | Percentage of Participants With Negative Minimal Residual Disease (MRD) | From randomization (Day -3) up to 6.6 years | MRD negativity rate is defined as the percentage of participants who had negative MRD at any time point after the date of randomization and prior to subsequent antimyeloma therapy. MRD was assessed in participants who achieved CR or better. |
| Secondary | Percentage of Participants With Stringent Complete Response (sCR) | From randomization (Day -3) up to 6.6 years | sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by IHC, immunofluorescence or 2- to 4-color FC. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; \<5% PCs in bone marrow. |
| Secondary | Overall Response Rate (ORR) | From randomization (Day -3) up to 6.6 years | ORR was the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required. VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \< 5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. |
| Secondary | Overall Survival (OS) | From randomization (Day -3) up to 8.7 years | OS was measured from the date of randomization to the date of the death. Median OS was estimated by using the Kaplan-Meier method. |
| Secondary | Time to Disease Progression (TTP) | From randomization (Day -3) up to 6.6 years | TTP was defined as the time from the date of randomization to date of first documented evidence of PD or death due to PD, whichever occurred first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 g/dL); Urine M-component (absolute increase \>=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. |
| Secondary | Time to Response | From randomization (Day -3) up to 6.6 years | Time to first response, time to VGPR or better, time to CR or better and time to best response was reported for this endpoint. Time to response: time from date of randomization to first efficacy evaluation that met criteria for PR/better as their best response (PR, CR, or better) based on IMWG criteria. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of \>=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. Based on computerized algorithm, according to IMWG response criteria, VGPR or better: proportion of participants with a response of VGPR or better (i.e., VGPR, CR or sCR), CR or better: proportion of participants with a response of CR or better (i.e., CR or sCR). |
| Secondary | Duration of Response (DoR) | From randomization (Day -3) up to 6.6 years | DoR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 g/dL); Urine M-component (absolute increase \>=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. |
| Secondary | Time to Subsequent Anti-myeloma Treatment | From randomization (Day -3) up to 8.7 years | Time to subsequent anti-myeloma treatment was defined as the time from randomization to the start of subsequent anti-myeloma treatment. Kaplan-Meier method was used for the analysis. |
| Secondary | Progression-free Survival on Next Line of Therapy (PFS2) | From randomization (Day -3) up to 6.6 years | PFS2 was defined as the time from randomization to progression on next line of therapy or death, whichever comes first. Disease progression on next line of treatment was based on investigator judgment. |
| 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) | EORTC QLQ-C30 was 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire included 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores were transformed to 0 to 100 scale, with higher scores represented better GHS and functioning, and more symptoms. Negative change from baseline values showed deterioration in quality of life or functioning and reduction in symptom and positive values indicated improvement and worsening of symptoms. |
| 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) | EQ-5D-5L was a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale was designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. |
| 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) | EQ-5D-5L was standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L included 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provided a profile of participant's health state 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflected increasing levels of difficulty. Participants indicated their health state by selecting the most appropriate level in each of the 5D. Responses to the 5D scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom scoring algorithm). Higher score indicated better health state. |
| 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). | PFS for participants with cytogenic high risk was reported. PFS was time from date of randomization to either PD or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD: an increase of 25% from lowest response value in one of following: serum and urine M-component (absolute increase must be \>=0.5 g/dL and \>=200 mg/24h respectively); Only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute \>10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to PC proliferative disorder. High risk was defined as positive for any of del17p, t(14;16) or t(4;14) by (corrected serum calcium \>11.5 mg/dL) Fluorescence In Situ Hybridization (FISH)/Karyotype. |
| Secondary | Sub-group Analysis: Overall Response Rate (ORR) | From randomization (Day -3) up to 6.6 years | ORR for participants with cytogenic high risk was reported. ORR: percentage of participants who achieved PR/better per IMWG criteria. PR: \>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by \>=90% or \<200mg/24h. If serum/urine M-protein were not measurable, decrease of \>=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. If present at baseline, \>=50% reduction in size of soft tissue plasmacytomas was required. VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum and urine M-protein \<100mg/24h. CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% PCs in bone marrow; sCR: CR in addition to normal FLC ratio, absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. High risk: positive for any of del17p, t(14;16) or t(4;14) by FISH/Karyotype. |
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/registered