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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03275285
Registration number
NCT03275285
Ethics application status
Date submitted
5/09/2017
Date registered
7/09/2017
Date last updated
20/02/2024
Titles & IDs
Public title
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
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Scientific title
Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines
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Secondary ID [1]
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U1111-1195-5957
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Secondary ID [2]
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EFC15246
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Universal Trial Number (UTN)
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Trial acronym
IKEMA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - isatuximab SAR650984
Treatment: Drugs - carfilzomib
Treatment: Drugs - dexamethasone
Experimental: Isatuximab + Carfilzomib + Dexamethasone (IKd) - Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth [po]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.
Active Comparator: Carfilzomib + Dexamethasone (Kd) - Carfilzomib (intravenous) on day 1, 2, 8, 9, 15, 16 + dexamethasone (intravenous or po) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.
Treatment: Drugs: isatuximab SAR650984
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Treatment: Drugs: carfilzomib
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Treatment: Drugs: dexamethasone
Pharmaceutical form: tablets or solution for infusion
Route of administration: oral or intravenous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis
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Assessment method [1]
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Time (in months) from randomization to date of 1st documentation of progressive disease (PD)/date of death from any cause, whichever comes 1st. If PD & death are not observed before cut-off date/date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever comes 1st. PD(IMWG criteria):any 1 of following:Increase(inc) of >=25% in serum M-component from nadir; serum M component inc >=1 g/dL in 2 consecutive assessment, if starting M component >=5 g/dL; and/or inc of >=25% in urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc >=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion if >1 lesion/ >=50% increase in longest diameter of previous soft tissue extramedullary disease lesion >1 cm in short axis. Estimated by Kaplan-Meier method.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months)
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Primary outcome [2]
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Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis
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Assessment method [2]
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Time (in months) from randomization to date of 1st PD documentation/death date, whichever is 1st. If PD & death not observed before cut-off date/date of further anti-myeloma treatment initiation, PFS censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever was 1st. Progression/deaths occurring >8 weeks after last disease assessment censored at earliest date of last disease assessment without evidence of progression before initiation of new anti-myeloma treatment & cut-off date. PD (IMWG criteria): meeting any 1: Inc >=25% in Serum M-component from nadir; serum M component inc >=1 g/dL in 2 consecutive assessment, if starting M component >=5 g/dL; and/or inc >=25% in Urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc >=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion >1 cm short axis.
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Timepoint [2]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Primary outcome [3]
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Progression Free Survival as Determined by Independent Response Committee: Final Analysis
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Assessment method [3]
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PFS: time (in months) from randomization to date of first documentation of PD or date of death from any cause, whichever comes first. If PD and death are not observed before analysis cut-off date or date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment or analysis cut-off date, whichever comes first. PD as per IMWG criteria: any 1 of following: Inc of >=25% in Serum M-component from nadir; serum M component increase >=1 g/dL in 2 consecutive assessment, if starting M component was >=5 g/dL; and/or inc of >=25% in Urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc >=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion if >1 lesion/ >=50% inc in longest diameter of previous soft tissue extramedullary disease lesion >1 cm in short axis. PFS estimated by Kaplan-Meier method.
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Timepoint [3]
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From randomization until the final analysis data cut-off date of 14 January 2022 (the median duration of follow-up was 43.96 months)
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Primary outcome [4]
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Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis
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Assessment method [4]
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Time (in months) from randomization to date of 1st documentation of PD/date of death from any cause, whichever comes 1st. If PD & death are not observed before cut-off date/date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment not showing PD/cut-off date, whichever comes 1st. Progressions/deaths occurring >8 weeks after last disease assessment were censored at earliest date of last valid disease assessment not showing PD before initiation of further anti-myeloma treatment & cut-off date. PD (per IMWG criteria): meeting any 1 criteria: Inc of >=25% in serum M-component from nadir; serum M component inc >=1 g/dL in 2 consecutive assessment, if starting M component was >=5 g/dL; and/or inc of >=25% in urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc >=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion >1 cm in short axis.
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Timepoint [4]
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From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
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Secondary outcome [1]
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Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis
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Assessment method [1]
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OR: participants with sCR, CR, VGPR & partial response (PR) as best overall response assessed by IRC using IMWG response criteria (from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/cutoff date, whichever occurs 1st). sCR: negative immunofixation on serum & urine, disappearance of soft tissue plasmacytoma, <5% plasma cells in bone marrow aspirate (BMA) + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum & urine, disappearance of soft tissue plasmacytoma, <5% plasma cells in BMA. VGPR: serum & urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein + urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR:>=50% reduction of serum M-protein & decrease in 24h urinary M-protein by >=90%/<200mg/24h, if present at baseline,>=50% decrease in SPD of soft tissue plasmacytoma.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [2]
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Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis
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Assessment method [2]
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VGPR or better: defined as participants with sCR, CR and VGPR as the best overall response (defined as best response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment or cut-off date whichever occurs first) as per IRC. As per IMWG response criteria: sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in BMAs plus normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in BMAs. VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma.
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Timepoint [2]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [3]
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Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis
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Assessment method [3]
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Percentage of participants with sCR, CR and VGPR for whom MRD assessed by sequencing was negative at any time after first dose of study treatment. MRD was assessed centrally by next-generation sequencing in bone marrow aspiration samples from participants who achieve VGPR or better, to determine depth of response at molecular level. VGPR or better: percentage of participants with sCR, CR and VGPR. sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in BMAs plus normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in BMAs. VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma.
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Timepoint [3]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [4]
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Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis
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Assessment method [4]
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Percentage of participants with sCR, CR and VGPR for whom MRD assessed by sequencing was negative at any time after first dose of study treatment. MRD was assessed centrally by next-generation sequencing in BM aspiration samples from participants who achieve VGPR or better, to determine depth of response at molecular level. VGPR or better: percentage of participants with sCR, CR and VGPR. sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates plus normal FLC ratio, absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma.
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Timepoint [4]
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From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
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Secondary outcome [5]
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Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis
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Assessment method [5]
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Complete response was defined as the participants with sCR and CR. IMWG response criteria for sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates plus normal free light chain (FLC) ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates. Complete response at the time of the final analysis was assessed with hydrashift isatuximab immunofixation electrophoresis (IFE) assay, which separated immunoglobulin G (IgG) isatuximab from IgG M protein.
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Timepoint [5]
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From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
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Secondary outcome [6]
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Percentage of Participants With Complete Response With MRD Negativity: Final Analysis
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Assessment method [6]
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MRD negativity was defined as the percentage of participants for whom MRD was negative by next-generation sequencing at any timepoint after first dose of study treatment. Threshold for negativity is 10^-5. MRD status in a participant was negative if at least one result of the assessment was negative in the participant otherwise MRD was considered as positive (MRD status reported as positive, missing or unevaluable). CR: participants with sCR and CR. IMWG response criteria for sCR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates plus normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates. Complete response at the time of the final analysis was assessed with Hydrashift isatuximab IFE assay, which separated IgG isatuximab from IgG M protein.
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Timepoint [6]
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From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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Overall survival, defined as the time from the date of randomization to death from any cause. The data reported is based on cut-off date of 7 Feb 2023.
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Timepoint [7]
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From randomization until the final analysis data cut-off date of 7 Feb 2023 (the median duration of follow-up was 56.61 months)
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Secondary outcome [8]
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Duration of Response (DOR): Primary Analysis
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Assessment method [8]
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DOR: time (in months) from date of 1st IRC determined response for participants achieving PR/better to date of 1st documented PD determined by IRC/death, whichever happens 1st. If disease progression/death before analysis cut-off date was not observed, DOR was censored at date of last valid disease assessment performed prior to initiation of further anti-myeloma treatment/data cut-off date, whichever was 1st. PD (IMWG criteria): inc of >=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute inc must be >=0.5 g/dL), serum M-protein inc >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute inc must be >=200mg/24 hour),appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >=50% inc in the longest diameter of previous lesion >1 cm in short axis. PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90%/<200mg/24 h. Estimated by Kaplan Meier method.
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Timepoint [8]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [9]
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Time to Progression (TTP): Primary Analysis
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Assessment method [9]
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TTP was defined as time in months from randomization to the date of first documentation of PD (as determined by the IRC). If progression was not observed before the analysis cut-off date or the date of initiation of further anti-myeloma treatment, TTP was censored at the date of the last valid disease assessment not showing disease progression performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. As per IMWG criteria, PD was defined for participants with inc of >= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute inc must be >= 0.5 g/dL), serum M-protein inc >=1 g/dL if the lowest M component was >=5 g/dL; urine M-component (the absolute inc must be >=200 mg/24hour), appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >=50% inc in the longest diameter of a previous lesion >1 centimeter in short axis.
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Timepoint [9]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [10]
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Time to First Response: Primary Analysis
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Assessment method [10]
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Time to first response was defined as the time (in months) from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. In the absence of response, participants were censored at the earliest of the date of the last valid disease assessment before disease progression or death, the date of the last valid disease assessment before initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. PR per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
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Timepoint [10]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [11]
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Time to Best Response: Primary Analysis
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Assessment method [11]
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Time to best response was defined as time (in months) from randomization to the date of first occurrence of IRC determined as best overall response (PR or better) that is subsequently confirmed. In absence of response, participants were censored at earliest date of last valid disease assessment before disease progression/death, date of last valid disease assessment before initiation of further anti-myeloma treatment (if any)/ analysis cut-off date, whichever was 1st. PR (IMWG criteria) was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. Best Overall Response was defined as the best response, using the IRC's assessment of response, from start of treatment until disease progression, death, initiation of further anti-myeloma treatment or cut-off date, whichever occurs 1st.
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Timepoint [11]
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From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
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Secondary outcome [12]
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Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022
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Assessment method [12]
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PFS2 defined as time (in months) from date of randomization to date of 1st documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment /death from any cause, whichever comes 1st. Participants alive without progression after initiation of further anti-myeloma treatment before analysis cut-off date, PFS2 censored at date of last follow-up visit not showing disease progression after initiation of further anti-myeloma treatment /analysis cut-off date, whichever comes 1st. As per IMWG criteria, PD: defined for participants with increase of >= 25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be >= 0.5 g/dL), serum M-protein increase >=1 g/dL if lowest M component was >=5 g/dL; urine M-component (absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter short axis.
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Timepoint [12]
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From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
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Secondary outcome [13]
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Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023
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Assessment method [13]
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PFS2 defined as time (in months) from date of randomization to date of 1st documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment /death from any cause, whichever comes 1st. Participants alive without progression after initiation of further anti-myeloma treatment before analysis cut-off date, PFS2 censored at date of last follow-up visit not showing disease progression after initiation of further anti-myeloma treatment /analysis cut-off date, whichever comes 1st. As per IMWG criteria, PD: defined for participants with increase of >= 25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be >= 0.5 g/dL), serum M-protein increase >=1 g/dL if lowest M component was >=5 g/dL; urine M-component (absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter short axis.
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Timepoint [13]
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From randomization until the overal survival analysis data cut-off date of 07 Feb 2023 (the median duration of follow-up was 56.61 months)
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Secondary outcome [14]
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Number of Participants With Renal Response (RR): Primary Analysis
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Assessment method [14]
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RR comprises of complete RR (CR renal), partial RR (PR renal) & minor RR (MR renal). CR renal was defined as an improvement in estimated glomerular filtration rate (eGFR) from <50 mL/min/1.73m^2 at Baseline to >=60 mL/min/1.73m^2 in at least 1 assessment during the treatment period (time from first dose of study treatment up to 30 days after last dose of study treatment); PR renal was defined as improvement in eGFR from <15 mL/min/1.73m^2 at baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m^2 during the on-treatment-period and MR renal was defined as an improvement in eGFR from <15 mL/min/1.73m^2 at Baseline to at least 1 assessment in the range of 15 to 30 mL/min/1.73m^2 during the on-treatment-period or from 15 to 30 mL/min/1.73m^2 at Baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m^2 during the on-treatment-period.
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Timepoint [14]
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From the first dose of study treatment to 30 days following the last administration of study treatment (maximum duration: up to 114 weeks)
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Secondary outcome [15]
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Health Related Quality of Life (HRQL): Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status Score at Specified Timepoints
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Assessment method [15]
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EORTC QLQ-C30 is a cancer-specific instrument that contains 30 items & provides multidimensional assessment of HRQL. EORTC QLQ-C30 includes global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale & are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as ([{Q29+Q30}/2]-1)/6*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant. Results reported for primary analysis with data cut-off date 7-Feb-2020.
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Timepoint [15]
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Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
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Secondary outcome [16]
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HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis
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Assessment method [16]
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EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. It is used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to treatment or the disease. Disease symptoms domain is one of the four domain scores. Disease symptoms domain consist of 6 questions and the score uses 4-point scale (1 'Not at All' to 4 'Very Much'). Disease Symptoms Domain Score is calculated as ([{Q31+Q32+Q33+Q34+Q35+Q36}/6]-1)/3*100. Scores are averaged, and transformed to 0-100 scale, where higher scores = more symptoms and lower HRQL.
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Timepoint [16]
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Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
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Secondary outcome [17]
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HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis
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Assessment method [17]
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EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain consists of 10 questions and the score uses a 4-point scale (1 'Not at All' to 4 'Very Much'). Side Effects of Treatment Score (MYSE) is calculated as ([{Q37+Q38+Q39+Q40+Q41+Q42+Q43+Q44+Q45+Q46}/10]-1)/3*100. Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.
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Timepoint [17]
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Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
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Secondary outcome [18]
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HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis
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Assessment method [18]
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EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. It is used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to treatment or the disease. It consists of one question and scores are based on the 4-point Likert scale ranging from "Not at all" to "Very much". Body image score is calculated as: (1 - [Q47-1]/3)*100. Scores are averaged, and transformed to scale ranging from 0 to 100. A higher score represents a better quality of life.
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Timepoint [18]
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Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
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Secondary outcome [19]
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HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Future Perspective at Specified Timepoints: Primary Analysis
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Assessment method [19]
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EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. It is used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to treatment or the disease. It consists of three questions and the scores are based on the 4-point Likert scale ranging from "Not at all" to "Very much". Future Perspective score is calculated as (1 - ([{Q48+Q49+Q50}/3] -1)/3)*100. Scores are averaged and transformed to scale ranging from 0 to 100. A higher score represents a better quality of life.
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Timepoint [19]
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Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
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Secondary outcome [20]
0
0
HRQL: Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints: Primary Analysis
Query!
Assessment method [20]
0
0
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
Query!
Timepoint [20]
0
0
Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Query!
Secondary outcome [21]
0
0
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis
Query!
Assessment method [21]
0
0
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.
Query!
Timepoint [21]
0
0
Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Query!
Secondary outcome [22]
0
0
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis
Query!
Assessment method [22]
0
0
Ceoi is the plasma concentration observed at the end of intravenous infusion.
Query!
Timepoint [22]
0
0
End of infusion on Cycle 1 Day 1 and Cycle 1 Day 15; Cycle 2 Day 1
Query!
Secondary outcome [23]
0
0
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis
Query!
Assessment method [23]
0
0
Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.
Query!
Timepoint [23]
0
0
Pre-infusion on Cycle 1 Day 1, Day 8, Day 15 and Day 22, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and Cycle 10 Day 1
Query!
Secondary outcome [24]
0
0
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Carfilzomib: Primary Analysis
Query!
Assessment method [24]
0
0
Cmax was defined as the maximum concentration observed after the first infusion calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [24]
0
0
Cycle 1: pre-dose (0 hour), 30 minutes (min), 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [25]
0
0
Pharmacokinetics: Clast of Carfilzomib: Primary Analysis
Query!
Assessment method [25]
0
0
Clast was defined as the last concentration observed above the lower limit of quantification.
Query!
Timepoint [25]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [26]
0
0
Pharmacokinetics: Tmax of Carfilzomib: Primary Analysis
Query!
Assessment method [26]
0
0
Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [26]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [27]
0
0
Pharmacokinetics: Tlast of Carfilzomib: Primary Analysis
Query!
Assessment method [27]
0
0
Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [27]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [28]
0
0
Pharmacokinetics: Area Under the Plasma Concentration Time Curve (AUC) of Carfilzomib: Primary Analysis
Query!
Assessment method [28]
0
0
AUC was defined as area under the plasma concentration-time curve extrapolated to infinity according to the equation: AUC= AUClast + Clast/?z. AUC was calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [28]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [29]
0
0
Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) of Carfilzomib: Primary Analysis
Query!
Assessment method [29]
0
0
AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration. AUClast was calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [29]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [30]
0
0
Pharmacokinetics: Percentage of Extrapolation of AUC (AUCext) of Carfilzomib: Primary Analysis
Query!
Assessment method [30]
0
0
AUCext was defined as the percentage of the extrapolation of AUC, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [30]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [31]
0
0
Pharmacokinetics: Terminal Half-life (t1/2z) of Carfilzomib: Primary Analysis
Query!
Assessment method [31]
0
0
T1/2 was defined as the time required for the concentration of the drug to reach half of its original value, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [31]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [32]
0
0
Pharmacokinetics: Clearance at Steady State (CLss) of Carfilzomib: Primary Analysis
Query!
Assessment method [32]
0
0
CLss was defined as a quantitative measure of the rate at which a drug substance is removed from the body at steady state, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [32]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [33]
0
0
Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis
Query!
Assessment method [33]
0
0
Volume of Distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Query!
Timepoint [33]
0
0
Cycle 1: pre-dose (0 hour), 30 min, 35 min, 45 min, 60 min, 1 hour 30 min, 2 hours 30 min and 4 hours 30 min post-dose on Day 15
Query!
Secondary outcome [34]
0
0
Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis
Query!
Assessment method [34]
0
0
ADA were categorized as: pre-existing, treatment induced, and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA with an increase in titer during the ADA on-study observation period.
Query!
Timepoint [34]
0
0
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 111 weeks)
Query!
Secondary outcome [35]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): Final Analysis
Query!
Assessment method [35]
0
0
Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly/birth defect, was a medically important event.
Query!
Timepoint [35]
0
0
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 265 weeks for Kd arm and 268 weeks for IKd arm)
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
- Participants with MM previously treated with prior 1 to 3 lines and with measurable
serum M-protein (>= 0.5 gram/deciliter) and/or urine M-protein (>= 200 milligram/24
hours).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
- Participants previously pretreated with carfilzomib, who never achieved at least one
minor response during previous therapies and/or last previous therapy completed within
14 last days.
- Participants with serum free light chain (FLC) measurable disease only.
- Participants less than 18 years old, participants with Eastern Cooperative Oncology
Group performance status more than 2.
- Participants with inadequate biological tests.
- Participants with myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft, New York Heart Association class III or IV
congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or
transient ischemic attack within last 6 months, and/or left ventricular ejection
fraction lower than 40%.
- Participants with previous cancer unless disease free for more than 5 years or in situ
cancer curatively treated.
- Participants with known acquired immunodeficiency syndrome related illness or human
immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C
active infection.
- Women of childbearing potential or male participant with women of childbearing
potential who do not agree to use highly effective method of birth control.
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/10/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
19/11/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
302
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Investigational Site Number : 0360005 - Blacktown
Query!
Recruitment hospital [2]
0
0
Investigational Site Number : 0360006 - Tweed Heads
Query!
Recruitment hospital [3]
0
0
Investigational Site Number : 0360002 - Wollongong
Query!
Recruitment hospital [4]
0
0
Investigational Site Number : 0360001 - Fitzroy
Query!
Recruitment hospital [5]
0
0
Investigational Site Number : 0360004 - Heidelberg West
Query!
Recruitment hospital [6]
0
0
Investigational Site Number : 0360007 - Nedlands
Query!
Recruitment hospital [7]
0
0
Investigational Site Number : 0360008 - West Perth
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [3]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [5]
0
0
3081 - Heidelberg West
Query!
Recruitment postcode(s) [6]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [7]
0
0
6005 - West Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
South Carolina
Query!
Country [3]
0
0
Brazil
Query!
State/province [3]
0
0
Bahia
Query!
Country [4]
0
0
Brazil
Query!
State/province [4]
0
0
Rio Grande Do Sul
Query!
Country [5]
0
0
Brazil
Query!
State/province [5]
0
0
São Paulo
Query!
Country [6]
0
0
Brazil
Query!
State/province [6]
0
0
Rio De Janeiro
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
British Columbia
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
New Brunswick
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Quebec
Query!
Country [10]
0
0
Czechia
Query!
State/province [10]
0
0
Brno
Query!
Country [11]
0
0
Czechia
Query!
State/province [11]
0
0
Olomouc
Query!
Country [12]
0
0
Czechia
Query!
State/province [12]
0
0
Ostrava - Poruba
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Praha 2
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Lille
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Nantes
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Paris
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Pessac
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Pierre Benite
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
POITIERS Cedex
Query!
Country [20]
0
0
Greece
Query!
State/province [20]
0
0
Athens
Query!
Country [21]
0
0
Greece
Query!
State/province [21]
0
0
Patra
Query!
Country [22]
0
0
Greece
Query!
State/province [22]
0
0
Thessaloniki
Query!
Country [23]
0
0
Hungary
Query!
State/province [23]
0
0
Budapest
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Kaposvár
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Bologna
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Pisa
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Reggio Emilia
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Torino
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Iwate
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Kumamoto
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Nagano
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Shizuoka
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Tokyo
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Yamagata-shi
Query!
Country [35]
0
0
Korea, Republic of
Query!
State/province [35]
0
0
Seoul-teukbyeolsi
Query!
Country [36]
0
0
Korea, Republic of
Query!
State/province [36]
0
0
Busan
Query!
Country [37]
0
0
New Zealand
Query!
State/province [37]
0
0
Auckland
Query!
Country [38]
0
0
New Zealand
Query!
State/province [38]
0
0
Wellington
Query!
Country [39]
0
0
Russian Federation
Query!
State/province [39]
0
0
Ekaterinburg
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Kirov
Query!
Country [41]
0
0
Russian Federation
Query!
State/province [41]
0
0
Novosibirsk
Query!
Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Catalunya [Cataluña]
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Valenciana, Comunidad
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Madrid
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Sevilla
Query!
Country [46]
0
0
Turkey
Query!
State/province [46]
0
0
Adana
Query!
Country [47]
0
0
Turkey
Query!
State/province [47]
0
0
Ankara
Query!
Country [48]
0
0
Turkey
Query!
State/province [48]
0
0
Bursa
Query!
Country [49]
0
0
Turkey
Query!
State/province [49]
0
0
Istanbul
Query!
Country [50]
0
0
Turkey
Query!
State/province [50]
0
0
Samsun
Query!
Country [51]
0
0
United Kingdom
Query!
State/province [51]
0
0
Devon
Query!
Country [52]
0
0
United Kingdom
Query!
State/province [52]
0
0
Leicestershire
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
Somerset
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study it to compare the efficacity of isatuximab when combined to
carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple
myeloma already treated with 1 to 3 prior lines of therapy.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03275285
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03275285
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