Contributions
Abstract: PB1697
Type: Publication Only
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Duration of response in multiple myeloma patients has significantly ameliorated due to introduction of new drugs, such as proteasome inhibitors, immunomolulatory agents and monoclonal antibodies. Carfilzomib is an approved treatment option beyond first line.
Aims
The aim of our study is the efficacy and safety of carfilzomib in daily practice.
Methods
In a cohort of 30 patients since 2017, 21 received carfilzomib in combination with lenalidomide and dexamethasone (KRd), 9 with dexamethasone only (Kd). The study cohort consists of 11 male and 19 female patients with median age 68 (41-80) years old, 17 IgG, 10 IgA, 3 free light chain disease. Carfilzomib was administered as 2nd line treatment in 12 patients, as 3rd in 5, as 4th in 8, as 5th in 3 and as 6th in 2 patients. Patients received a median of 8 (1-51) treatment cycles. Left ventricular ejection fraction (LVEF%) was determined by heart ultrasound prior to treatment initiation in all patients. Median LVEF% value was 65% (55%>80%).
Results
Serum creatinine and markers of hemolysis (reticulocyte count, LDH, bilirubin) remained constantly within normal ranges. Platelet count did not deviate from baseline throughout treatment. No schistocytosis or microangiopathy occurred. One female patient developed new onset hypertension during the 6th KRd cycle and one Kd patient was in need of antihypertensive regimen modifications upon treatment initiation. All patients underwent LVEF reevaluation by echocardiogram beyond 6-mo treatment and q6mo thereafter. Reduction in LVEF more than 10% comparing to baseline was noted in 3/20 (15%) evaluated patients. Two sudden deaths occurred in two patients without cardiac history, one 72 y-o male patient during cycle 7 and one 75 y-o female upon treatment initiation. Death was attributed to physical causes and no autopsy was performed. Disease assessment was performed in 29 patients. At least partial response (PR) was achieved in 22 (76%) patients, 7 (32%) in VGPR. Median progression free survival (PFS) and overall survival (OS) was 15 (1-31) and 34 (18-50) months respectively. Median PFS and 3-year PFS was significantly higher in patients with 1-3 vs >3 prior treatment lines 37 (19-54) vs 9 (8-10) months and 40% vs 0% respectively, p<0.001. A trend for improved OS and 3-year OS was evident in patients with 1-2 vs >2 prior treatment lines, not reached vs 22 months and 61% vs 19% respectively, p=0.06. For lenalidomide refractory patients receiving Kd vs lenalidomide naïve KRd patients, median PFS was 9 (4-14) mo vs 28 (21-35) mo (p<0.001). Twelve- month PFS and 36-mo PFS was, 27% vs 69% and 39% vs 0% respectively.
Conclusion
In conclusion, carfilzomib administration in relapsed/refractory multiple myeloma exhibits adequate efficacy. Cardiovascular assessment is mandatory prior to treatment initiation and during treatment cycles. Quality and duration of response was augmented when integrated in 1st or 2nd relapse treatment plan.
Keyword(s): Myeloma, Proteasome inhibitor, Safety
Abstract: PB1697
Type: Publication Only
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Duration of response in multiple myeloma patients has significantly ameliorated due to introduction of new drugs, such as proteasome inhibitors, immunomolulatory agents and monoclonal antibodies. Carfilzomib is an approved treatment option beyond first line.
Aims
The aim of our study is the efficacy and safety of carfilzomib in daily practice.
Methods
In a cohort of 30 patients since 2017, 21 received carfilzomib in combination with lenalidomide and dexamethasone (KRd), 9 with dexamethasone only (Kd). The study cohort consists of 11 male and 19 female patients with median age 68 (41-80) years old, 17 IgG, 10 IgA, 3 free light chain disease. Carfilzomib was administered as 2nd line treatment in 12 patients, as 3rd in 5, as 4th in 8, as 5th in 3 and as 6th in 2 patients. Patients received a median of 8 (1-51) treatment cycles. Left ventricular ejection fraction (LVEF%) was determined by heart ultrasound prior to treatment initiation in all patients. Median LVEF% value was 65% (55%>80%).
Results
Serum creatinine and markers of hemolysis (reticulocyte count, LDH, bilirubin) remained constantly within normal ranges. Platelet count did not deviate from baseline throughout treatment. No schistocytosis or microangiopathy occurred. One female patient developed new onset hypertension during the 6th KRd cycle and one Kd patient was in need of antihypertensive regimen modifications upon treatment initiation. All patients underwent LVEF reevaluation by echocardiogram beyond 6-mo treatment and q6mo thereafter. Reduction in LVEF more than 10% comparing to baseline was noted in 3/20 (15%) evaluated patients. Two sudden deaths occurred in two patients without cardiac history, one 72 y-o male patient during cycle 7 and one 75 y-o female upon treatment initiation. Death was attributed to physical causes and no autopsy was performed. Disease assessment was performed in 29 patients. At least partial response (PR) was achieved in 22 (76%) patients, 7 (32%) in VGPR. Median progression free survival (PFS) and overall survival (OS) was 15 (1-31) and 34 (18-50) months respectively. Median PFS and 3-year PFS was significantly higher in patients with 1-3 vs >3 prior treatment lines 37 (19-54) vs 9 (8-10) months and 40% vs 0% respectively, p<0.001. A trend for improved OS and 3-year OS was evident in patients with 1-2 vs >2 prior treatment lines, not reached vs 22 months and 61% vs 19% respectively, p=0.06. For lenalidomide refractory patients receiving Kd vs lenalidomide naïve KRd patients, median PFS was 9 (4-14) mo vs 28 (21-35) mo (p<0.001). Twelve- month PFS and 36-mo PFS was, 27% vs 69% and 39% vs 0% respectively.
Conclusion
In conclusion, carfilzomib administration in relapsed/refractory multiple myeloma exhibits adequate efficacy. Cardiovascular assessment is mandatory prior to treatment initiation and during treatment cycles. Quality and duration of response was augmented when integrated in 1st or 2nd relapse treatment plan.
Keyword(s): Myeloma, Proteasome inhibitor, Safety