TriangleNCT03275285 · CITED IN SOURCE DOCUMENTS
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2026-02-09
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.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis
Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis
Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis
Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis
Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis
Percentage of Participants With Complete Response With MRD Negativity: Final Analysis
Overall Survival (OS)
Duration of Response (DOR): Primary Analysis
Time to Progression (TTP): Primary Analysis
Time to First Response: Primary Analysis
Time to Best Response: Primary Analysis
Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022
Second Progression Free Survival (PFS2): Overal Survival Analysis - Data Cut-off Date of 07 Feb 2023
Number of Participants With Renal Response (RR): Primary Analysis
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
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
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
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
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
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
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
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Carfilzomib: Primary Analysis
Pharmacokinetics: Clast of Carfilzomib: Primary Analysis
Pharmacokinetics: Tmax of Carfilzomib: Primary Analysis
Pharmacokinetics: Tlast of Carfilzomib: Primary Analysis
Pharmacokinetics: Area Under the Plasma Concentration Time Curve (AUC) of Carfilzomib: Primary Analysis
Pharmacokinetics: Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) of Carfilzomib: Primary Analysis
Pharmacokinetics: Percentage of Extrapolation of AUC (AUCext) of Carfilzomib: Primary Analysis
Pharmacokinetics: Terminal Half-life (t1/2z) of Carfilzomib: Primary Analysis
Pharmacokinetics: Clearance at Steady State (CLss) of Carfilzomib: Primary Analysis
Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Carfilzomib: Primary Analysis
Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): LPLV Analysis
Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis
Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis
Progression Free Survival as Determined by Independent Response Committee: Final Analysis
Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion criteria: * Participants with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (\>= 0.5 gram/deciliter) and/or urine M-protein (\>= 200 milligram/24 hours). 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth \[po\]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.
- intervention Names
- Drug: isatuximab SAR650984
- Drug: carfilzomib
- Drug: dexamethasone
- label
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- type
- EXPERIMENTAL
- description
- Carfilzomib (intravenous) on day 1, 2, 8, 9, 15, 16 + dexamethasone (intravenous or po) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.
- intervention Names
- Drug: carfilzomib
- Drug: dexamethasone
- label
- Carfilzomib + Dexamethasone (Kd)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- description
- Pharmaceutical form: solution for infusion Route of administration: intravenous
- name
- isatuximab SAR650984
- other Names
- Sarclisa
- type
- DRUG
- arm Group Labels
- Carfilzomib + Dexamethasone (Kd)
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- description
- Pharmaceutical form: solution for infusion Route of administration: intravenous
- name
- carfilzomib
- other Names
- Kyprolis
- type
- DRUG
- arm Group Labels
- Carfilzomib + Dexamethasone (Kd)
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- description
- Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous
- name
- dexamethasone
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- SINGLE
- who Masked
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 302
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis
- 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)
- description
- 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.
- measure
- Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis
- 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)
- description
- 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.
- measure
- Progression Free Survival as Determined by Independent Response Committee: Final Analysis
- 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)
- description
- 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.
- measure
- Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis
- 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)
- secondary Outcomes
- description
- 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.
- measure
- Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis
- 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)
- description
- 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.
- measure
- Percentage of Participants With Very Good Partial Response (VGPR) or Better as Determined by Independent Response Committee: Primary Analysis
- 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)
- description
- 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.
- measure
- Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Primary Analysis
- 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)
- description
- 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.
- measure
- Percentage of Participants With VGPR or Better With Minimal Residual Disease (MRD) Negativity: Final Analysis
- 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)
- description
- 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.
- measure
- Percentage of Participants With Complete Response (CR) as Per Independent Response Committee: Final Analysis
- 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)
- description
- 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.
- measure
- Percentage of Participants With Complete Response With MRD Negativity: Final Analysis
- 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)
- description
- 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.
- measure
- Overall Survival (OS)
- 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)
- description
- 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.
- measure
- Duration of Response (DOR): Primary Analysis
- 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)
- description
- 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.
- measure
- Time to Progression (TTP): Primary Analysis
- 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)
- description
- 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.
- measure
- Time to First Response: Primary Analysis
- 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)
- description
- 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.
- measure
- Time to Best Response: Primary Analysis
- 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)
- description
- 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.
- measure
- Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022
- 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)
Full study description
- 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.
Source references
- references
- citation
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- type
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- type
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- citation
- Yong K, Martin T, Dimopoulos MA, Mikhael J, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Casca F, Mace S, Risse ML, Moreau P. Isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple myeloma (IKEMA): overall survival analysis of a phase 3, randomised, controlled trial. Lancet Haematol. 2024 Oct;11(10):e741-e750. doi: 10.1016/S2352-3026(24)00148-0. Epub 2024 Jul 24.
- pmid
- 39067465
- type
- DERIVED
- citation
- Thoren K, Menad S, Nouadje G, Mace S. Isatuximab-Specific Immunofixation Electrophoresis Assay to Remove Interference in Serum M-Protein Measurement in Patients with Multiple Myeloma. J Appl Lab Med. 2024 Jul 1;9(4):661-671. doi: 10.1093/jalm/jfae028.
- pmid
- 38573925
- type
- DERIVED
- citation
- Facon T, Moreau P, Baker R, Min CK, Leleu X, Mohty M, Karlin L, Armstrong NM, Tekle C, Schwab S, Risse ML, Martin T. Isatuximab plus carfilzomib and dexamethasone in patients with early versus late relapsed multiple myeloma: IKEMA subgroup analysis. Haematologica. 2024 Feb 1;109(2):604-616. doi: 10.3324/haematol.2023.283073.
- pmid
- 37584290
- type
- DERIVED
- citation
- Kawano Y, Kim K, Min CK, Koh Y, Ishizawa K, Kim SH, Ito S, Tanaka J, Uchiyama M, Ishida T, Kim JS, Moreau P, Martin T, Tada K, Risse ML, Suzuki K. Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis. Clin Lymphoma Myeloma Leuk. 2023 Oct;23(10):e360-e367. doi: 10.1016/j.clml.2023.06.011. Epub 2023 Jul 3.
- pmid
- 37479547
- type
- DERIVED
- citation
- Martin T, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Casca F, Mace S, Risse ML, Moreau P. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. Blood Cancer J. 2023 May 9;13(1):72. doi: 10.1038/s41408-023-00797-8.
- pmid
- 37156782
- type
- DERIVED
- citation
- Beksac M, Spicka I, Hajek R, Bringhen S, Jelinek T, Martin T, Mikala G, Moreau P, Symeonidis A, Rawlings AM, van de Velde H, Richardson PG. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022 Nov;122:106948. doi: 10.1016/j.leukres.2022.106948. Epub 2022 Sep 6.
- pmid
- 36108425
- type
- DERIVED
- citation
- Moreau P, Dimopoulos MA, Yong K, Mikhael J, Risse ML, Asset G, Martin T. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design. Future Oncol. 2020 Jan;16(2):4347-4358. doi: 10.2217/fon-2019-0431. Epub 2019 Dec 13.
- pmid
- 31833394
- type
- DERIVED
Source notices and limitations
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- ICARIA-MM (assessment by the IRC) Figure 1 IKEMA The efficacy and safety of SARCLISA in combination with carfilzomib and dexamethasone were evaluated in IKEMA (NCT03275285), a multicenter, multinational, randomized, open-label, 2-arm, phase 3 study in patients with relapsed and/or refractory multiple myeloma. Patients had receive
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- ponse (VGPR) 26 (39.4%) Partial response (PR) 5 (7.6%) 14.4 In Combination with Isatuximab and Dexamethasone for Relapsed or Refractory Multiple Myeloma IKEMA (NCT03275285) The efficacy and safety of Kyprolis in combination with isatuximab and dexamethasone were evaluated in IKEMA, a multicenter, multinational, randomized, open-l
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Preserved source evidence · Not medical advice