Contributions
Abstract: PB1693
Type: Publication Only
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Multiple myeloma (MM) is the second most common hematological cancer worldwide. Although it is still considered an incurable disease, MM might be controlled for long periods of time. Notwithstanding the therapeutic approach to MM is guided by eligibility to autologous stem cell transplantation (ASCT), treatment was markedly improved with the availability of agents approved in the last 15 years, leading patients with MM to improvements in 5 to 10 year survival rates. Daratumumab (Dara) is a CD38 monoclonal antibody approved in Portugal in monotherapy or in combination with bortezomib (DVd), Lenalidomide (DRd) with dexamethasone, for the treatment of relapsed or refractory myeloma (RRMM).
Aims
The aim of this study was to characterize a portuguese RRMM population of a small center treated with Daratumumab in different regimens.
Methods
We performed a retrospective observational cohort study of 55 adult MM patients diagnosed between 2010 and 2019 and analyzed a subpopulation of 11 RRMM patients treated with Daratumumab regimens. We assessed response according to IMWG criteria and progression free survival (PFS) was determined using Kaplan-Meier analysis.
Results
Of 55 MM patients, 20% received regimens with Daratumumab (N=11/55). In this subgroup of patients 36% (n=4/11) had relapsed MM and 64% (n=7/11) presented MM refractory to one or more previous treatment lines. Amongst Dara associations, 63,6% patients (n=7/11) received DRd, 18% (n=2/11) received DKd, one patient received Daratumumab in monotherapy and one patient received DVd (Daratumumab, Bortezomib, Dexamethasone). The median age at diagnosis was 59 years (range 41-69). The median time to initiation of Dara from diagnosis was 4 years (range 1-8). Patients had received a median 2 prior lines of therapy (range 1-3). Seven patients (64%, n=7/11) had previously undergone single or tandem ASCT. In the Rd-and Kd-groups all patients were previously exposed to bortezomib. In the Kd-group and Vd-group patients were exposed to Lenalidomide. The median number of administered cycles was 15 (range 2-27) in the Rd-group, 5 (range 1-9) in the Kd-group and 45 cycles in the Vd-group. The regimens were well tolerated with few grade adverse events (AE). Grade 3/4 neutropenia and thrombocytopenia (18%) were the most common AE. One patient developed toxidermia to Lenalidomide. When treated with Dara regimens, clinical relapse was observed in two patients (18%) and death in 6%. One patient was on hemodialysis as renal failure related to MM, and during DRd treatment there was vital improvement in renal functional with hemodialysis independency. Regarding to response, in the Rd-group CR was achieved in 71% and VGPR in 14%, in the Kd-group CR was achieved in 100% and in Vd-group VGPR was achieved in 100%. Stable disease after Daratumumab was achieved by 7 patients (64%). OS was 65,8 months (range 17-120). Median PFS on Dara was 18 months (range 2-40, 95%>IC) in Rd-group, 13 months (range 1-25) in the Kd-group and in the Vd-group 39 months. Patients with extra medullary disease had poorer median PFS than those without.
Conclusion
Current MM prevalence is expected to increase since incidence is higher than mortality and new pharmacological treatments have been reshaping the market and the treatment landscape. These small real-life results are lined up with the results of POLLUX trial and demonstrate that in daily practice, Daratumumab regimens are safe, well-tolerated with benefits on PFS and OS in RRMM.
Keyword(s): Immune therapy, Multiple myeloma, Refractory, Relapse
Abstract: PB1693
Type: Publication Only
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Multiple myeloma (MM) is the second most common hematological cancer worldwide. Although it is still considered an incurable disease, MM might be controlled for long periods of time. Notwithstanding the therapeutic approach to MM is guided by eligibility to autologous stem cell transplantation (ASCT), treatment was markedly improved with the availability of agents approved in the last 15 years, leading patients with MM to improvements in 5 to 10 year survival rates. Daratumumab (Dara) is a CD38 monoclonal antibody approved in Portugal in monotherapy or in combination with bortezomib (DVd), Lenalidomide (DRd) with dexamethasone, for the treatment of relapsed or refractory myeloma (RRMM).
Aims
The aim of this study was to characterize a portuguese RRMM population of a small center treated with Daratumumab in different regimens.
Methods
We performed a retrospective observational cohort study of 55 adult MM patients diagnosed between 2010 and 2019 and analyzed a subpopulation of 11 RRMM patients treated with Daratumumab regimens. We assessed response according to IMWG criteria and progression free survival (PFS) was determined using Kaplan-Meier analysis.
Results
Of 55 MM patients, 20% received regimens with Daratumumab (N=11/55). In this subgroup of patients 36% (n=4/11) had relapsed MM and 64% (n=7/11) presented MM refractory to one or more previous treatment lines. Amongst Dara associations, 63,6% patients (n=7/11) received DRd, 18% (n=2/11) received DKd, one patient received Daratumumab in monotherapy and one patient received DVd (Daratumumab, Bortezomib, Dexamethasone). The median age at diagnosis was 59 years (range 41-69). The median time to initiation of Dara from diagnosis was 4 years (range 1-8). Patients had received a median 2 prior lines of therapy (range 1-3). Seven patients (64%, n=7/11) had previously undergone single or tandem ASCT. In the Rd-and Kd-groups all patients were previously exposed to bortezomib. In the Kd-group and Vd-group patients were exposed to Lenalidomide. The median number of administered cycles was 15 (range 2-27) in the Rd-group, 5 (range 1-9) in the Kd-group and 45 cycles in the Vd-group. The regimens were well tolerated with few grade adverse events (AE). Grade 3/4 neutropenia and thrombocytopenia (18%) were the most common AE. One patient developed toxidermia to Lenalidomide. When treated with Dara regimens, clinical relapse was observed in two patients (18%) and death in 6%. One patient was on hemodialysis as renal failure related to MM, and during DRd treatment there was vital improvement in renal functional with hemodialysis independency. Regarding to response, in the Rd-group CR was achieved in 71% and VGPR in 14%, in the Kd-group CR was achieved in 100% and in Vd-group VGPR was achieved in 100%. Stable disease after Daratumumab was achieved by 7 patients (64%). OS was 65,8 months (range 17-120). Median PFS on Dara was 18 months (range 2-40, 95%>IC) in Rd-group, 13 months (range 1-25) in the Kd-group and in the Vd-group 39 months. Patients with extra medullary disease had poorer median PFS than those without.
Conclusion
Current MM prevalence is expected to increase since incidence is higher than mortality and new pharmacological treatments have been reshaping the market and the treatment landscape. These small real-life results are lined up with the results of POLLUX trial and demonstrate that in daily practice, Daratumumab regimens are safe, well-tolerated with benefits on PFS and OS in RRMM.
Keyword(s): Immune therapy, Multiple myeloma, Refractory, Relapse