MSc
Tine Rosenberg
Quality of Life Research Center, Department of Hematology
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 01.08.2020 | |
| Slut | 01.08.2030 | |
Quality of Life for patients in The REMNANT study - RElapse from Mrd Negativity As iNdication for Treatment study - changing the approach to relapse myeloma treatment
Short summary
This study is part of a Norwegian clinical trial testing the potential of starting treatment when patients with multiple myeloma experience the earliest signs of relapsed disease, i.e. MRD-positivity, versus waiting for the standard indications for relapse treatment. The clinical study tests if early treatment holds a survival benefit, and in our sub-study, we will investigate how it affects patients' quality of life.
Rationale
Until recently, consolidation and maintenance therapy have not commonly been used in Norwegian patients with multiple myeloma eligible for autologous stem cell transplantation (ASCT), and most patients do not receive additional treatment until they relapse after first line treatment. However, in the 2019 version of the Norwegian treatment guidelines, bortezomib-lenalidomide-dexamethasone (VRd) treatment was implemented as a consolidation step after ASCT in order to obtain deeper responses and longer progression free survival (PFS). No studies in myeloma have reported on health-related quality of life (HRQOL) during consolidation treatment with 4 cycles of VRd, and there is limited data on how HRQOL is affected when patients are treated for longer periods of time compared to stopping treatment after ASCT. In the REMNANT study, part 1, we will report on HRQOL during and after 4 cycles of consolidation therapy and compare to baseline (at diagnosis). The rationale for the REMNANT study, part 2, is to answer one of the major research questions in modern myeloma treatment; do patients benefit from earlier relapse treatment when the tumor burden is lower and how does early relapse treatment affect HRQOL. The impact on the patients´ HRQOL of early versus late intervention is unknown. A prolongation in PFS and overall survival (OS) is assumed to be associated with patient-specific benefits, but this needs to be counterbalanced in relation to early versus late treatment-related adverse events. In other words, the prolongation of life should not negatively affect HRQOL and should be associated with a longer duration of good-quality of life. Therefore, important secondary endpoints in the REMNANT part 2 study will be patient-centered outcomes.
Description of the cohort
Patients with newly diagnosed multiple myeloma according to the official criteria from the International Myeloma Working Group, eligible for high-dose melphalan with ASCT, will be enrolled in the study. Patients will be enrolled from all Hematologic Departments in Norway (n=14). Based on power calculations, we plan to include 352 patients.
Data and biological material
The HRQOL sub-study hosted at OPEN includes only Patient Reported Outcome (PRO) data. These are collected using the following questionnaires: EQ-5D, Functional Assessment of Chronic Illness Therapy Treatment Satisfaction - General (FACIT-TS-G), Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (Fact-GOG), The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30), and Generalized Anxiety Disorder (GAD-7).
Collaborating researchers and departments
Oslo Myeloma Center, Oslo University Hospital