Plasma Cell Myeloma
Conditions
Keywords
Anti-CD38 monoclonal antibody
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.
Detailed description
The duration of the study for a patient will include a period for screening of up to 3 weeks. Patients will be treated until disease progression, unacceptable AE, or patient decision to stop the study treatment. After study treatment discontinuation, patients will have follow-up visits until the analysis of overall survival.
Interventions
Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUGcarfilzomib
Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUGdexamethasone
Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months) | 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. |
| Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Progression Free Survival as Determined by Independent Response Committee: Final Analysis | From randomization until the final analysis data cut-off date of 14 January 2022 (the median duration of follow-up was 43.96 months) | 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. |
| Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis | From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis | From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months) | 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. |
| Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis | From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months) | 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. |
| Percentage of Participants With Complete Response With MRD Negativity: Final Analysis | From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months) | 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. |
| Overall Survival (OS) | From randomization until the final analysis data cut-off date of 7 Feb 2023 (the median duration of follow-up was 56.61 months) | 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. |
| Duration of Response (DOR): Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Time to Progression (TTP): Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Time to First Response: Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) of Carfilzomib: Primary Analysis | 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 | 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. |
| Time to Best Response: Primary Analysis | From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months) | 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. |
| Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022 | From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months) | 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. |
| Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023 | 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) | 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. |
| Number of Participants With Renal Response (RR): Primary Analysis | From the first dose of study treatment to 30 days following the last administration of study treatment (maximum duration: up to 114 weeks) | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| Pharmacokinetics: Percentage of Extrapolation of AUC (AUCext) of Carfilzomib: Primary Analysis | 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 | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| 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 | Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks) | 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. |
| Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis | End of infusion on Cycle 1 Day 1 and Cycle 1 Day 15; Cycle 2 Day 1 | Ceoi is the plasma concentration observed at the end of intravenous infusion. |
| Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | 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 | Ctrough was the plasma concentration observed just before treatment administration during repeated dosing. |
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Carfilzomib: Primary Analysis | 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 | 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. |
| Pharmacokinetics: Clast of Carfilzomib: Primary Analysis | 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 | Clast was defined as the last concentration observed above the lower limit of quantification. |
| Pharmacokinetics: Tmax of Carfilzomib: Primary Analysis | 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 | Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab. |
| Pharmacokinetics: Tlast of Carfilzomib: Primary Analysis | 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 | 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. |
| Pharmacokinetics: Area Under the Plasma Concentration Time Curve (AUC) of Carfilzomib: Primary Analysis | 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 | AUC was defined as area under the plasma concentration-time curve extrapolated to infinity according to the equation: AUC= AUClast + Clast/λz. AUC was calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab. |
| Pharmacokinetics: Terminal Half-life (t1/2z) of Carfilzomib: Primary Analysis | 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 | 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. |
| Pharmacokinetics: Clearance at Steady State (CLss) of Carfilzomib: Primary Analysis | 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 | 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. |
| Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis | 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 | 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. |
| Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 111 weeks) | 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. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): LPLV Analysis | From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to 349 weeks for Kd arm and 356 weeks for IKd arm (maximum duration of treatment exposure) | 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. |
Countries
Australia, Brazil, Canada, Czechia, France, Greece, Hungary, Italy, Japan, New Zealand, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Participant flow
Recruitment details
Study was conducted at 69 active centers in 16 countries. A total of 341 participants were screened between 25 October 2017 and 21 March 2019, of which 39 participants were screen failure due to not meeting eligibility criteria. Randomization was stratified by number of prior lines (1 versus \>1) & revised international staging system (R-ISS) I or II versus III versus not classified. Reason for not completed = Reason for definitive treatment discontinuation.
Pre-assignment details
First result analysis (A) reported was for a data cut-off date of 7 Feb 2020 for efficacy outcomes, 14 Jan 2022 for CR, MRD and PFS2. PFS data was reported at both cut-off dates: 7 Feb 2020 & 14 Jan 2022. Primary A of PFS refers to planned interim A conducted at 103 events (death/PD) with cut-off date 7 Feb 2020 & Final A of PFS conducted at 159 events with cut-off date 14 Jan 2022. Data cut-off for overall survival and LPLV was 7 Feb 2023 and 3 Jan 2025, respectively.
Participants by arm
| Arm | Count |
|---|---|
| Carfilzomib + Dexamethasone (Kd) Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 265 weeks). | 123 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 268 weeks). | 179 |
| Total | 302 |
Baseline characteristics
| Characteristic | Total | Isatuximab + Carfilzomib + Dexamethasone (IKd) | Carfilzomib + Dexamethasone (Kd) |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 9.9 | 63.3 years STANDARD_DEVIATION 9.8 | 62.9 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants | 26 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants | 14 Participants | 12 Participants |
| Race (NIH/OMB) White | 214 Participants | 131 Participants | 83 Participants |
| Sex: Female, Male Female | 133 Participants | 78 Participants | 55 Participants |
| Sex: Female, Male Male | 169 Participants | 101 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 59 / 123 | 83 / 179 |
| other Total, other adverse events | 113 / 122 | 167 / 177 |
| serious Total, serious adverse events | 74 / 122 | 129 / 177 |
Outcome results
Primary
Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis
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.
Time frame: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
Population: Analysis was performed on the ITT population. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis | 20.76 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis | 41.66 months |
95.4% CI: [0.424, 0.832]
Primary
Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on the ITT. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis | 20.27 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis | NA months |
Comparison: Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.p-value: 0.001699.2% CI: [0.317, 0.948]Stratified Log-Rank test
Primary
Progression Free Survival as Determined by Independent Response Committee: Final Analysis
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.
Time frame: From randomization until the final analysis data cut-off date of 14 January 2022 (the median duration of follow-up was 43.96 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Progression Free Survival as Determined by Independent Response Committee: Final Analysis | 19.15 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Progression Free Survival as Determined by Independent Response Committee: Final Analysis | 35.65 months |
95.4% CI: [0.418, 0.792]
Primary
Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months)
Population: Analysis was performed on Intent to Treat (ITT) population that included all participants who gave their informed consent and for whom there was a confirmation of successful allocation of a randomization number by the interactive response technology (IRT).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis | 19.15 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis | NA months |
Comparison: Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.p-value: 0.000799% CI: [0.318, 0.889]Stratified Log-Rank test
Secondary
Duration of Response (DOR): Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on the subset of participants with PR or better (defined as responders) in ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Duration of Response (DOR): Primary Analysis | NA months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Duration of Response (DOR): Primary Analysis | NA months |
95% CI: [0.269, 0.672]
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | 9.75 score on a scale | Standard Deviation 21.62 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | 3.82 score on a scale | Standard Deviation 21.71 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | 3.60 score on a scale | Standard Deviation 21.8 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | 6.33 score on a scale | Standard Deviation 20.73 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | 6.60 score on a scale | Standard Deviation 19.28 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | 7.27 score on a scale | Standard Deviation 21.04 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | 5.26 score on a scale | Standard Deviation 22.14 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | 8.70 score on a scale | Standard Deviation 23.16 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | 4.91 score on a scale | Standard Deviation 21.55 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | 12.40 score on a scale | Standard Deviation 21.42 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | 3.13 score on a scale | Standard Deviation 20.5 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | 10.78 score on a scale | Standard Deviation 20.97 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | 4.34 score on a scale | Standard Deviation 20.06 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | 12.50 score on a scale | Standard Deviation 21.81 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | 3.58 score on a scale | Standard Deviation 21.2 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | 17.98 score on a scale | Standard Deviation 22.27 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | 8.59 score on a scale | Standard Deviation 22.37 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | 15.56 score on a scale | Standard Deviation 22.02 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | 4.22 score on a scale | Standard Deviation 22.55 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | 14.81 score on a scale | Standard Deviation 26.28 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | 7.08 score on a scale | Standard Deviation 19.76 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | 15.00 score on a scale | Standard Deviation 28.5 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | 4.17 score on a scale | Standard Deviation 22.92 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | -6.14 score on a scale | Standard Deviation 22.9 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | 1.52 score on a scale | Standard Deviation 21.11 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | -11.90 score on a scale | Standard Deviation 25.86 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | -1.60 score on a scale | Standard Deviation 20.06 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | 0.05 score on a scale | Standard Deviation 20.29 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | -1.89 score on a scale | Standard Deviation 23.71 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | -1.23 score on a scale | Standard Deviation 23.12 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | -1.44 score on a scale | Standard Deviation 22.12 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | -1.77 score on a scale | Standard Deviation 22.38 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | -1.06 score on a scale | Standard Deviation 20.78 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | -0.78 score on a scale | Standard Deviation 22.17 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | -1.21 score on a scale | Standard Deviation 20.35 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | -1.10 score on a scale | Standard Deviation 20.18 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | 0.84 score on a scale | Standard Deviation 22.4 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | -1.26 score on a scale | Standard Deviation 20.63 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | -0.98 score on a scale | Standard Deviation 21.43 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | 0.16 score on a scale | Standard Deviation 20.51 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | -1.07 score on a scale | Standard Deviation 20.94 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | 0.00 score on a scale | Standard Deviation 22.18 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | -0.36 score on a scale | Standard Deviation 20.56 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | -1.23 score on a scale | Standard Deviation 20.12 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | -1.05 score on a scale | Standard Deviation 20.4 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | -1.85 score on a scale | Standard Deviation 21.54 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | 0.31 score on a scale | Standard Deviation 21.24 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | 3.15 score on a scale | Standard Deviation 20.73 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | 0.38 score on a scale | Standard Deviation 14.88 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | 3.13 score on a scale | Standard Deviation 17.18 |
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | -1.65 score on a scale | Standard Deviation 25.55 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | 0.00 score on a scale | Standard Deviation 25.2 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | -2.14 score on a scale | Standard Deviation 24.82 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | -1.31 score on a scale | Standard Deviation 27.46 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | -1.83 score on a scale | Standard Deviation 24.02 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | -1.42 score on a scale | Standard Deviation 28.62 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | -1.80 score on a scale | Standard Deviation 25.22 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | 1.48 score on a scale | Standard Deviation 30.11 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | 1.98 score on a scale | Standard Deviation 23.01 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | 0.00 score on a scale | Standard Deviation 31.62 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | -1.85 score on a scale | Standard Deviation 29.01 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | 0.00 score on a scale | Standard Deviation 27.22 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | -0.77 score on a scale | Standard Deviation 27.83 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | -4.76 score on a scale | Standard Deviation 34.8 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | -2.05 score on a scale | Standard Deviation 25.6 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | -8.77 score on a scale | Standard Deviation 36.59 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | -0.69 score on a scale | Standard Deviation 26.34 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | -13.33 score on a scale | Standard Deviation 30.34 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | -3.89 score on a scale | Standard Deviation 26.1 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | -25.93 score on a scale | Standard Deviation 36.43 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | -5.16 score on a scale | Standard Deviation 25.08 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | -53.33 score on a scale | Standard Deviation 18.26 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | -4.52 score on a scale | Standard Deviation 26.59 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | -5.65 score on a scale | Standard Deviation 21.58 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | -1.29 score on a scale | Standard Deviation 23.76 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | -9.36 score on a scale | Standard Deviation 27.28 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | -1.27 score on a scale | Standard Deviation 21.31 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | 1.27 score on a scale | Standard Deviation 26.84 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | -1.10 score on a scale | Standard Deviation 28.04 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | -2.89 score on a scale | Standard Deviation 27.29 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | -1.60 score on a scale | Standard Deviation 26.93 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | -3.03 score on a scale | Standard Deviation 24.36 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | -0.25 score on a scale | Standard Deviation 24.84 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | -1.02 score on a scale | Standard Deviation 25.8 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | -1.33 score on a scale | Standard Deviation 25.54 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | -0.55 score on a scale | Standard Deviation 23.47 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | -0.55 score on a scale | Standard Deviation 25.09 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | -2.63 score on a scale | Standard Deviation 21.79 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | -3.24 score on a scale | Standard Deviation 25.57 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | -2.22 score on a scale | Standard Deviation 24.58 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | -2.94 score on a scale | Standard Deviation 22.55 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | -1.98 score on a scale | Standard Deviation 26.17 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | -1.77 score on a scale | Standard Deviation 24.62 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | -3.70 score on a scale | Standard Deviation 26.18 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | -0.76 score on a scale | Standard Deviation 24.75 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | -3.20 score on a scale | Standard Deviation 26.74 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | -1.85 score on a scale | Standard Deviation 27.02 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | -5.41 score on a scale | Standard Deviation 24.23 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | -3.03 score on a scale | Standard Deviation 25.01 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | -8.33 score on a scale | Standard Deviation 25.82 |
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | -5.45 score on a scale | Standard Deviation 17.48 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | -5.56 score on a scale | Standard Deviation 17.69 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | -5.65 score on a scale | Standard Deviation 18 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | -8.06 score on a scale | Standard Deviation 18.27 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | -6.11 score on a scale | Standard Deviation 18.07 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | -7.57 score on a scale | Standard Deviation 19.01 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | -5.56 score on a scale | Standard Deviation 18.48 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | -7.16 score on a scale | Standard Deviation 17.67 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | -8.28 score on a scale | Standard Deviation 15.33 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | -7.18 score on a scale | Standard Deviation 19.57 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | -3.24 score on a scale | Standard Deviation 17.78 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | -11.93 score on a scale | Standard Deviation 17.09 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | -6.64 score on a scale | Standard Deviation 17.44 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | -9.72 score on a scale | Standard Deviation 16.74 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | -5.30 score on a scale | Standard Deviation 16.27 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | -9.94 score on a scale | Standard Deviation 18.76 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | -5.78 score on a scale | Standard Deviation 17.01 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | -5.56 score on a scale | Standard Deviation 25.11 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | -7.69 score on a scale | Standard Deviation 17.06 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | -6.17 score on a scale | Standard Deviation 29.97 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | -6.94 score on a scale | Standard Deviation 17.76 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | -12.22 score on a scale | Standard Deviation 28.97 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | -8.66 score on a scale | Standard Deviation 16.35 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | 2.35 score on a scale | Standard Deviation 23.1 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | -5.34 score on a scale | Standard Deviation 15.75 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | 1.75 score on a scale | Standard Deviation 23.48 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | -3.40 score on a scale | Standard Deviation 19.58 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | -7.42 score on a scale | Standard Deviation 18.15 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | -7.46 score on a scale | Standard Deviation 17.99 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | -6.37 score on a scale | Standard Deviation 18.32 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | -6.16 score on a scale | Standard Deviation 19.88 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | -4.78 score on a scale | Standard Deviation 20.77 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | -5.47 score on a scale | Standard Deviation 19.96 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | -5.51 score on a scale | Standard Deviation 17.86 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | -4.98 score on a scale | Standard Deviation 17.24 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | -7.10 score on a scale | Standard Deviation 17.57 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | -6.89 score on a scale | Standard Deviation 17.58 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | -5.95 score on a scale | Standard Deviation 16.44 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | -7.08 score on a scale | Standard Deviation 17.98 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | -5.19 score on a scale | Standard Deviation 17.84 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | -5.77 score on a scale | Standard Deviation 18.66 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | -4.29 score on a scale | Standard Deviation 19.73 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | -3.78 score on a scale | Standard Deviation 17.93 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | -3.64 score on a scale | Standard Deviation 16.7 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | -3.54 score on a scale | Standard Deviation 21.63 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | -3.81 score on a scale | Standard Deviation 19.7 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | -5.35 score on a scale | Standard Deviation 22.48 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | -6.01 score on a scale | Standard Deviation 19.53 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | -9.60 score on a scale | Standard Deviation 18.16 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | -14.58 score on a scale | Standard Deviation 21.65 |
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | 6.60 score on a scale | Standard Deviation 20.44 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | 9.55 score on a scale | Standard Deviation 24.16 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | 7.26 score on a scale | Standard Deviation 21.1 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | 12.42 score on a scale | Standard Deviation 24.51 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | 8.42 score on a scale | Standard Deviation 21.81 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | 12.29 score on a scale | Standard Deviation 21.64 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | 8.56 score on a scale | Standard Deviation 22.79 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | 11.36 score on a scale | Standard Deviation 22.41 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | 4.84 score on a scale | Standard Deviation 22.08 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | 9.21 score on a scale | Standard Deviation 24.96 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | 8.02 score on a scale | Standard Deviation 21.69 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | 10.13 score on a scale | Standard Deviation 24.67 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | 8.17 score on a scale | Standard Deviation 21.93 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | 10.32 score on a scale | Standard Deviation 22.41 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | 6.84 score on a scale | Standard Deviation 24.51 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | 8.77 score on a scale | Standard Deviation 25.28 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | 7.67 score on a scale | Standard Deviation 22.64 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | 9.63 score on a scale | Standard Deviation 27.81 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | 11.11 score on a scale | Standard Deviation 20.04 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | 1.23 score on a scale | Standard Deviation 24.5 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | 7.41 score on a scale | Standard Deviation 22.51 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | -4.44 score on a scale | Standard Deviation 24.34 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | 8.85 score on a scale | Standard Deviation 22.86 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | -3.95 score on a scale | Standard Deviation 22.86 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | 0.54 score on a scale | Standard Deviation 19.33 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | -3.70 score on a scale | Standard Deviation 31.45 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | 7.57 score on a scale | Standard Deviation 26.48 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | 9.70 score on a scale | Standard Deviation 24.76 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | 8.55 score on a scale | Standard Deviation 26.62 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | 7.56 score on a scale | Standard Deviation 26.98 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | 9.97 score on a scale | Standard Deviation 25.7 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | 8.47 score on a scale | Standard Deviation 24.74 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | 10.54 score on a scale | Standard Deviation 24.5 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | 8.57 score on a scale | Standard Deviation 28.26 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | 11.56 score on a scale | Standard Deviation 24.82 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | 12.02 score on a scale | Standard Deviation 24.23 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | 11.48 score on a scale | Standard Deviation 22.9 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | 10.72 score on a scale | Standard Deviation 23.18 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | 11.31 score on a scale | Standard Deviation 23.29 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | 12.28 score on a scale | Standard Deviation 22.27 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | 11.76 score on a scale | Standard Deviation 25.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | 10.89 score on a scale | Standard Deviation 25.29 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | 7.33 score on a scale | Standard Deviation 23.25 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | 8.40 score on a scale | Standard Deviation 25.5 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | 9.60 score on a scale | Standard Deviation 25.34 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | 10.65 score on a scale | Standard Deviation 26.15 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | 12.14 score on a scale | Standard Deviation 22.35 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | 12.61 score on a scale | Standard Deviation 20.48 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | 16.16 score on a scale | Standard Deviation 18.7 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | 15.28 score on a scale | Standard Deviation 16.67 |
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | 1.08 score on a scale | Standard Deviation 10.56 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | 1.53 score on a scale | Standard Deviation 12.07 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | 1.85 score on a scale | Standard Deviation 11.45 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | 1.91 score on a scale | Standard Deviation 11.36 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | 0.99 score on a scale | Standard Deviation 10.54 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | 1.68 score on a scale | Standard Deviation 11.57 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | 2.74 score on a scale | Standard Deviation 10.03 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | 1.23 score on a scale | Standard Deviation 11.56 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | 2.37 score on a scale | Standard Deviation 10.51 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | 2.07 score on a scale | Standard Deviation 11.62 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | 2.76 score on a scale | Standard Deviation 11.41 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | 2.08 score on a scale | Standard Deviation 11.81 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | -0.17 score on a scale | Standard Deviation 10.62 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | 3.38 score on a scale | Standard Deviation 12 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | 3.17 score on a scale | Standard Deviation 10.61 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | 0.83 score on a scale | Standard Deviation 11.38 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | 3.55 score on a scale | Standard Deviation 6.46 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | 7.85 score on a scale | Standard Deviation 9.93 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | 1.20 score on a scale | Standard Deviation 10.52 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | 12.35 score on a scale | Standard Deviation 7.17 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | 1.47 score on a scale | Standard Deviation 12.14 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | 11.85 score on a scale | Standard Deviation 4.06 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | 0.82 score on a scale | Standard Deviation 10.22 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | 4.63 score on a scale | Standard Deviation 13.01 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | 0.44 score on a scale | Standard Deviation 10.11 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | 5.56 score on a scale | Standard Deviation 16.22 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | 1.41 score on a scale | Standard Deviation 11.71 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | 0.84 score on a scale | Standard Deviation 12 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | 0.99 score on a scale | Standard Deviation 11.89 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | 2.36 score on a scale | Standard Deviation 11.94 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | 1.61 score on a scale | Standard Deviation 12.32 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | 2.14 score on a scale | Standard Deviation 10.76 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | 2.86 score on a scale | Standard Deviation 12.77 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | 1.49 score on a scale | Standard Deviation 11.96 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | 2.68 score on a scale | Standard Deviation 12.51 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | 2.03 score on a scale | Standard Deviation 12.16 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | 3.04 score on a scale | Standard Deviation 12.72 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | 2.12 score on a scale | Standard Deviation 12.33 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | 1.71 score on a scale | Standard Deviation 12.58 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | 1.87 score on a scale | Standard Deviation 11.8 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | 2.58 score on a scale | Standard Deviation 11.88 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | 4.10 score on a scale | Standard Deviation 12.77 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | 2.95 score on a scale | Standard Deviation 13.38 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | 2.16 score on a scale | Standard Deviation 11.56 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | 2.05 score on a scale | Standard Deviation 13.03 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | 2.74 score on a scale | Standard Deviation 12.87 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | -1.39 score on a scale | Standard Deviation 12.02 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | -2.54 score on a scale | Standard Deviation 11.33 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | -3.50 score on a scale | Standard Deviation 12.83 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | 1.51 score on a scale | Standard Deviation 12.51 |
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | 0.02 score on a scale | Standard Deviation 0.21 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | 0.05 score on a scale | Standard Deviation 0.18 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | 0.05 score on a scale | Standard Deviation 0.2 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | 0.06 score on a scale | Standard Deviation 0.16 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | 0.03 score on a scale | Standard Deviation 0.19 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | 0.05 score on a scale | Standard Deviation 0.15 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | 0.06 score on a scale | Standard Deviation 0.22 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | 0.02 score on a scale | Standard Deviation 0.15 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | 0.06 score on a scale | Standard Deviation 0.21 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | 0.03 score on a scale | Standard Deviation 0.2 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | 0.04 score on a scale | Standard Deviation 0.23 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | 0.06 score on a scale | Standard Deviation 0.17 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | 0.06 score on a scale | Standard Deviation 0.19 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | 0.03 score on a scale | Standard Deviation 0.15 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | 0.03 score on a scale | Standard Deviation 0.16 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | 0.05 score on a scale | Standard Deviation 0.19 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | 0.04 score on a scale | Standard Deviation 0.2 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | 0.05 score on a scale | Standard Deviation 0.18 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | 0.06 score on a scale | Standard Deviation 0.16 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | 0.04 score on a scale | Standard Deviation 0.24 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | 0.06 score on a scale | Standard Deviation 0.19 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | 0.05 score on a scale | Standard Deviation 0.38 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | 0.06 score on a scale | Standard Deviation 0.24 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | -0.03 score on a scale | Standard Deviation 0.25 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | 0.05 score on a scale | Standard Deviation 0.17 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | -0.08 score on a scale | Standard Deviation 0.27 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | 0.04 score on a scale | Standard Deviation 0.19 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | 0.05 score on a scale | Standard Deviation 0.22 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | 0.05 score on a scale | Standard Deviation 0.21 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | 0.04 score on a scale | Standard Deviation 0.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | 0.05 score on a scale | Standard Deviation 0.23 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | 0.04 score on a scale | Standard Deviation 0.21 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | 0.05 score on a scale | Standard Deviation 0.22 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | 0.04 score on a scale | Standard Deviation 0.19 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | 0.03 score on a scale | Standard Deviation 0.22 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | 0.05 score on a scale | Standard Deviation 0.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | 0.02 score on a scale | Standard Deviation 0.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | 0.03 score on a scale | Standard Deviation 0.19 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | 0.04 score on a scale | Standard Deviation 0.19 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | 0.05 score on a scale | Standard Deviation 0.18 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | 0.04 score on a scale | Standard Deviation 0.19 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | 0.03 score on a scale | Standard Deviation 0.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | 0.04 score on a scale | Standard Deviation 0.17 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | 0.03 score on a scale | Standard Deviation 0.18 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | 0.03 score on a scale | Standard Deviation 0.23 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | 0.02 score on a scale | Standard Deviation 0.22 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | 0.02 score on a scale | Standard Deviation 0.22 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | 0.00 score on a scale | Standard Deviation 0.27 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | 0.03 score on a scale | Standard Deviation 0.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | 0.04 score on a scale | Standard Deviation 0.22 |
Secondary
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
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.
Time frame: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 4 Day 1 | 6.03 score on a scale | Standard Deviation 16.73 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 15 Day 1 | 4.96 score on a scale | Standard Deviation 18.92 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 9 Day 1 | -0.14 score on a scale | Standard Deviation 17.46 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 16 Day 1 | 3.94 score on a scale | Standard Deviation 18.78 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 6 Day 1 | 2.80 score on a scale | Standard Deviation 18.56 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 17 Day 1 | 5.04 score on a scale | Standard Deviation 17.93 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 10 Day 1 | 2.76 score on a scale | Standard Deviation 17.41 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 18 Day 1 | 3.71 score on a scale | Standard Deviation 19.08 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 3 Day 1 | 4.70 score on a scale | Standard Deviation 16.13 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 19 Day 1 | 7.44 score on a scale | Standard Deviation 18.73 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 11 Day 1 | 3.86 score on a scale | Standard Deviation 20.07 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 20 Day 1 | 6.18 score on a scale | Standard Deviation 18.43 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 7 Day 1 | 0.64 score on a scale | Standard Deviation 21.69 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 21 Day 1 | 7.25 score on a scale | Standard Deviation 23.46 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 12 Day 1 | 5.29 score on a scale | Standard Deviation 18.51 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 22 Day 1 | 5.58 score on a scale | Standard Deviation 24.06 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 5 Day 1 | 3.40 score on a scale | Standard Deviation 16.89 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 23 Day 1 | 6.33 score on a scale | Standard Deviation 18.73 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 13 Day 1 | 6.81 score on a scale | Standard Deviation 19.57 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 24 Day 1 | 5.11 score on a scale | Standard Deviation 17.93 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 8 Day 1 | 1.48 score on a scale | Standard Deviation 17.11 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 25 Day 1 | 9.20 score on a scale | Standard Deviation 21.48 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 14 Day 1 | 7.95 score on a scale | Standard Deviation 18.12 |
| Carfilzomib + Dexamethasone (Kd) | 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 | End of Treatment | -4.40 score on a scale | Standard Deviation 18.66 |
| Carfilzomib + Dexamethasone (Kd) | 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 | Cycle 2 Day 1 | 2.42 score on a scale | Standard Deviation 17.04 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | End of Treatment | -7.80 score on a scale | Standard Deviation 21.08 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 2 Day 1 | 0.60 score on a scale | Standard Deviation 15.23 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 3 Day 1 | 3.47 score on a scale | Standard Deviation 17.8 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 4 Day 1 | 2.29 score on a scale | Standard Deviation 18.69 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 5 Day 1 | 2.35 score on a scale | Standard Deviation 19.73 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 6 Day 1 | 1.24 score on a scale | Standard Deviation 19.11 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 7 Day 1 | 2.24 score on a scale | Standard Deviation 18.85 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 8 Day 1 | 2.40 score on a scale | Standard Deviation 18.87 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 9 Day 1 | 2.93 score on a scale | Standard Deviation 19.04 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 10 Day 1 | 2.82 score on a scale | Standard Deviation 18.35 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 11 Day 1 | 3.77 score on a scale | Standard Deviation 18.51 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 12 Day 1 | 3.63 score on a scale | Standard Deviation 19.34 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 13 Day 1 | 4.94 score on a scale | Standard Deviation 18.41 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 14 Day 1 | 4.72 score on a scale | Standard Deviation 17.67 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 15 Day 1 | 3.23 score on a scale | Standard Deviation 18.87 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 16 Day 1 | 4.56 score on a scale | Standard Deviation 18.88 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 17 Day 1 | 4.97 score on a scale | Standard Deviation 18.55 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 18 Day 1 | 3.83 score on a scale | Standard Deviation 18.46 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 19 Day 1 | 3.69 score on a scale | Standard Deviation 18.37 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 20 Day 1 | 4.20 score on a scale | Standard Deviation 17.2 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 21 Day 1 | 3.26 score on a scale | Standard Deviation 18.97 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 22 Day 1 | 2.35 score on a scale | Standard Deviation 18.62 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 23 Day 1 | 6.44 score on a scale | Standard Deviation 18.34 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 24 Day 1 | 4.50 score on a scale | Standard Deviation 18.31 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 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 | Cycle 25 Day 1 | 5.00 score on a scale | Standard Deviation 18.83 |
Secondary
Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis
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.
Time frame: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 111 weeks)
Population: Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IKd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result. Data for this outcome measure was not planned to be collected and analyzed for Kd arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis | Pre-existing ADA | 0 Participants |
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis | Treatment induced ADA | 0 Participants |
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis | Treatment boosted ADA | 0 Participants |
Secondary
Number of Participants With Renal Response (RR): Primary Analysis
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.
Time frame: From the first dose of study treatment to 30 days following the last administration of study treatment (maximum duration: up to 114 weeks)
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' signifies participants with available data for each specified category. Here, 0 signifies that none of the participants were available for assessment at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Renal Response (RR): Primary Analysis | CR Renal | 4 Participants |
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Renal Response (RR): Primary Analysis | MR Renal | 1 Participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Number of Participants With Renal Response (RR): Primary Analysis | CR Renal | 13 Participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Number of Participants With Renal Response (RR): Primary Analysis | MR Renal | 4 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): Final Analysis
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.
Time frame: 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)
Population: Analysis was performed on safety population which included all who gave their informed consent and for whom there was confirmation of successful allocation of a randomization number by the IRT and received at least one dose or a part of a dose of the study treatments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): Final Analysis | Any TEAE | 119 Participants |
| Carfilzomib + Dexamethasone (Kd) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): Final Analysis | Any treatment emergent SAE | 74 Participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): Final Analysis | Any TEAE | 175 Participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): Final Analysis | Any treatment emergent SAE | 126 Participants |
Secondary
Overall Survival (OS)
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.
Time frame: From randomization until the final analysis data cut-off date of 7 Feb 2023 (the median duration of follow-up was 56.61 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Overall Survival (OS) | 50.60 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Overall Survival (OS) | NA months |
Secondary
Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis
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.
Time frame: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis | 28.5 percentage of participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis | 44.1 percentage of participants |
Secondary
Percentage of Participants With Complete Response With MRD Negativity: Final Analysis
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.
Time frame: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Percentage of Participants With Complete Response With MRD Negativity: Final Analysis | 12.2 percentage of participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Percentage of Participants With Complete Response With MRD Negativity: Final Analysis | 26.3 percentage of participants |
Secondary
Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis | 82.9 percentage of participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis | 86.6 percentage of participants |
Comparison: Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.p-value: 0.193Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis | 56.1 percentage of participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis | 72.6 percentage of participants |
Secondary
Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis
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.
Time frame: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis | 13.8 percentage of participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis | 33.5 percentage of participants |
Secondary
Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis | 13.0 percentage of participants |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis | 29.6 percentage of participants |
Secondary
Pharmacokinetics: Area Under the Plasma Concentration Time Curve (AUC) of Carfilzomib: Primary Analysis
AUC was defined as area under the plasma concentration-time curve extrapolated to infinity according to the equation: AUC= AUClast + Clast/λz. AUC was calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Area Under the Plasma Concentration Time Curve (AUC) of Carfilzomib: Primary Analysis | 784 nanograms*hour/milliliter(ng*h/mL) | Standard Deviation 509 |
Secondary
Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) of Carfilzomib: Primary Analysis | 779 ng*h/mL | Standard Deviation 505 |
Secondary
Pharmacokinetics: Clast of Carfilzomib: Primary Analysis
Clast was defined as the last concentration observed above the lower limit of quantification.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Clast of Carfilzomib: Primary Analysis | 3.00 ng/mL | Standard Deviation 5.11 |
Secondary
Pharmacokinetics: Clearance at Steady State (CLss) of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Clearance at Steady State (CLss) of Carfilzomib: Primary Analysis | 466 Liters/hour (L/h) | Standard Deviation 1190 |
Secondary
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Carfilzomib: Primary Analysis | 2090 nanogram/milliliter (ng/mL) | Standard Deviation 1360 |
Secondary
Pharmacokinetics: Percentage of Extrapolation of AUC (AUCext) of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Percentage of Extrapolation of AUC (AUCext) of Carfilzomib: Primary Analysis | 0 percentage of AUC | Geometric Coefficient of Variation 172 |
Secondary
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis
Ceoi is the plasma concentration observed at the end of intravenous infusion.
Time frame: End of infusion on Cycle 1 Day 1 and Cycle 1 Day 15; Cycle 2 Day 1
Population: Analysis was performed on pharmacokinetic (PK) population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Data for this outcome measure (OM) was not planned to be collected and analyzed for Kd arm. Here, 'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis | Cycle 1 Day 1 | 274.01 microgram/milliliter (mcg/mL) | Standard Deviation 183.67 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis | Cycle 1 Day 15 | 380.28 microgram/milliliter (mcg/mL) | Standard Deviation 85.7 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis | Cycle 2 Day 1 | 522.74 microgram/milliliter (mcg/mL) | Standard Deviation 204.11 |
Secondary
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis
Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here,'Number analyzed' signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 1 Day 1 | 3.66 mcg/mL | Standard Deviation 34.4 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 1 Day 8 | 82.14 mcg/mL | Standard Deviation 43.87 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 1 Day 15 | 180.02 mcg/mL | Standard Deviation 71.83 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 1 Day 22 | 252.63 mcg/mL | Standard Deviation 100.16 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 2 Day 1 | 324.28 mcg/mL | Standard Deviation 132.98 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 3 Day 1 | 295.78 mcg/mL | Standard Deviation 146.11 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 4 Day 1 | 342.48 mcg/mL | Standard Deviation 140.94 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 5 Day 1 | 389.25 mcg/mL | Standard Deviation 172.11 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 6 Day 1 | 427.16 mcg/mL | Standard Deviation 188.51 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 7 Day 1 | 433.22 mcg/mL | Standard Deviation 177.11 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 8 Day 1 | 490.51 mcg/mL | Standard Deviation 198.17 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 9 Day 1 | 486.07 mcg/mL | Standard Deviation 181.34 |
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis | Cycle 10 Day 1 | 490.08 mcg/mL | Standard Deviation 206.53 |
Secondary
Pharmacokinetics: Terminal Half-life (t1/2z) of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Terminal Half-life (t1/2z) of Carfilzomib: Primary Analysis | 0.860 hours |
Secondary
Pharmacokinetics: Tlast of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Tlast of Carfilzomib: Primary Analysis | 4.50 hours |
Secondary
Pharmacokinetics: Tmax of Carfilzomib: Primary Analysis
Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of carfilzomib with isatuximab.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Tmax of Carfilzomib: Primary Analysis | 0.54 hours |
Secondary
Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis
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.
Time frame: 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
Population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis | 453 Liters | Standard Deviation 1570 |
Secondary
Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022
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.
Time frame: From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)
Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022 | 35.58 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022 | 47.18 months |
Comparison: \[Not specified\]95% CI: [0.496, 0.941]
Secondary
Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023
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.
Time frame: 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)
Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023 | 32.36 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023 | 47.18 months |
Comparison: \[Not specified\]95% CI: [0.491, 0.895]
Secondary
Time to Best Response: Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Time to Best Response: Primary Analysis | 3.78 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Time to Best Response: Primary Analysis | 4.60 months |
95% CI: [0.74, 1.233]
Secondary
Time to First Response: Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Time to First Response: Primary Analysis | 1.12 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Time to First Response: Primary Analysis | 1.08 months |
95% CI: [0.888, 1.471]
Secondary
Time to Progression (TTP): Primary Analysis
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.
Time frame: From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
Population: Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | Time to Progression (TTP): Primary Analysis | 20.27 months |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | Time to Progression (TTP): Primary Analysis | NA months |
95% CI: [0.324, 0.757]