Contributions
Abstract: PB1688
Type: Publication Only
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Bortezomib-based triple drug regimen is the standard of care in Chinese multiple myeloma (MM) patient in front line setting, but there is huge economic and disease burden, and toxicity to bortezomib-based regimen. Oral regimen offers convenience to the patients, especially in China, because of the scarcity of top tier MM center and the community healthcare service system is not well established. Hence frequent communication between home and hospital is a burden for patients and their family. The feasibility of the in-class transition from a bortezomib-based treatment to an all oral ixazomib treatment has previously been demonstrated. Relatively good safety profiles of ixazomib make it possible for switching from a bortezomib-based induction regimen to an ixazomib-based regimen.
Aims
To assess the effectiveness of all oral ixazomib-based regimen in Chinese patients with MM, who had at the least a partial response (PR), after receiving bortezomib-based regimens as initial treatment.
Methods
This study will be an open-label, single-arm, multicenter, observational study among Chinese patients with MM in real world clinical setting. Patients (aged ≥18 years) who have been newly diagnosed with MM (NDMM) using International Myeloma Working Group criteria and have received a bortezomib-based triple-drug regimens for more than 2 cycles as initial therapy including bortezomib, cyclophosphamide and dexamethasone (VCD) or lenalidomide, bortezomib, and dexamethasone (VRD) or bortezomib, doxorubicin and dexamethasone (PAD) or bortezomib, thalidomide, and dexamethasone (VTD) will be enrolled in this study. At the time of enrollment, patient must achieve at least PR as defined by IMWG criteria. Approximately 320 eligible patients at 15 top MM hospitals in China will be treated with ixazomib-based regimens. All patients will be followed for 24 months once every 3 months unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.
Results
This study will assess the progression free survival (PFS) at 2 years for Chinese NDMM patients switched from a bortezomib-based induction regimen to ixazomib-based regimens as primary endpoint. The clinical effectiveness, safety and tolerability, patient-reported outcomes and heath economic/resource utilization will be evaluated as secondary endpoint. Meanwhile, we propose to get more available data to exploratorily evaluate minimal residual disease, influence on medication adherence and impact factors for clinical outcome.
Conclusion
The available clinical data has been confirmed that long-term therapies are necessary for MM
patients to improve disease control compared with fixed-duration treatment. The results of this
study may provide evidences to verify the benefits of switching from bortezomib-based induction regimen to ixazomib-based regimens in Chinese NDMM patients in real world clinical setting. Meanwhile, we hope the study could provide treatment ideas in clinical practice to ensure clinical efficacy while reducing burden of disease and toxicity which will help to achieve the goals of maximal benefit with long term treatment in MM patients.
Keyword(s): Bortezomib, Multiple myeloma
Abstract: PB1688
Type: Publication Only
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Bortezomib-based triple drug regimen is the standard of care in Chinese multiple myeloma (MM) patient in front line setting, but there is huge economic and disease burden, and toxicity to bortezomib-based regimen. Oral regimen offers convenience to the patients, especially in China, because of the scarcity of top tier MM center and the community healthcare service system is not well established. Hence frequent communication between home and hospital is a burden for patients and their family. The feasibility of the in-class transition from a bortezomib-based treatment to an all oral ixazomib treatment has previously been demonstrated. Relatively good safety profiles of ixazomib make it possible for switching from a bortezomib-based induction regimen to an ixazomib-based regimen.
Aims
To assess the effectiveness of all oral ixazomib-based regimen in Chinese patients with MM, who had at the least a partial response (PR), after receiving bortezomib-based regimens as initial treatment.
Methods
This study will be an open-label, single-arm, multicenter, observational study among Chinese patients with MM in real world clinical setting. Patients (aged ≥18 years) who have been newly diagnosed with MM (NDMM) using International Myeloma Working Group criteria and have received a bortezomib-based triple-drug regimens for more than 2 cycles as initial therapy including bortezomib, cyclophosphamide and dexamethasone (VCD) or lenalidomide, bortezomib, and dexamethasone (VRD) or bortezomib, doxorubicin and dexamethasone (PAD) or bortezomib, thalidomide, and dexamethasone (VTD) will be enrolled in this study. At the time of enrollment, patient must achieve at least PR as defined by IMWG criteria. Approximately 320 eligible patients at 15 top MM hospitals in China will be treated with ixazomib-based regimens. All patients will be followed for 24 months once every 3 months unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.
Results
This study will assess the progression free survival (PFS) at 2 years for Chinese NDMM patients switched from a bortezomib-based induction regimen to ixazomib-based regimens as primary endpoint. The clinical effectiveness, safety and tolerability, patient-reported outcomes and heath economic/resource utilization will be evaluated as secondary endpoint. Meanwhile, we propose to get more available data to exploratorily evaluate minimal residual disease, influence on medication adherence and impact factors for clinical outcome.
Conclusion
The available clinical data has been confirmed that long-term therapies are necessary for MM
patients to improve disease control compared with fixed-duration treatment. The results of this
study may provide evidences to verify the benefits of switching from bortezomib-based induction regimen to ixazomib-based regimens in Chinese NDMM patients in real world clinical setting. Meanwhile, we hope the study could provide treatment ideas in clinical practice to ensure clinical efficacy while reducing burden of disease and toxicity which will help to achieve the goals of maximal benefit with long term treatment in MM patients.
Keyword(s): Bortezomib, Multiple myeloma