Clinical and Demographic Characteristics of Multiple Myeloma Patients at Study Enrollment: Analysis of Doriant Study (NCT:04659798)

BACKGROUND: Multiple Myeloma is a heterogenous disease characterized by subsequent relapses in which the burden of the disease and previous treatments received could limit subsequent lines of therapy, as described in treatment guidelines. The disease becomes more aggressive after each relapse and the time between relapses is shorter, which means less duration of response per late line of treatment that could lead into treatment refractoriness. Progression free survival is shorter after each treatment line and the prognosis of the patients gets worse. Increasing the DoT at relapse has a positive impact in the overall survival (OS) and in the clinical evolution of the disease. However, duration of treatment (DoT) is not reported outside clinical trials and there is a lack of information in clinical practice. There is increasing evidence to Support a treatment paradigm shift from the traditional fixed duration strategy to a continuous therapy approach to improve outcomes. The determinants of DoT and its relationship with survival in real-life practice have been little investigated, including reasons for treatment discontinuation. This research aims to investigate the relationship between DoT and outcomes in clinical practice, also analyzing the satisfaction with the treatment received from patients with MM and AL amyloidosis as an exploratory endpoint.

OBJECTIVE: To investigate the relationship between DoT and response according to selected treatment strategy (fixed vs continuous) among patients diagnosed with MM and/or AL amyloidosis. We provide an update regarding baseline characteristics of the MM population enrolled in the study as per the information collected during the entry study visit.

METHODS: Prospective, non-interventional, multi-centre study in real-life practice in 14 Spanish hospitals. The study enrolled subjects aged 18 or older diagnosed with MM and/or AL amyloidosis who started treatment up to 12 months before the inclusion. The study has enrolled a total of 240 patients, 207 of them with MM diagnosis.

RESULTS: Of the 207 MM enrolled patients, 191 (92,3%) were eligible for this analysis. 106 (55.5%) were at 1L of treatment, 52 (27.2%) at 2L, 24 (12.6%) at 3L and 9 (4.7%) at subsequent lines. 30 patients were at maintenance setting. The median age was 74 (67,79) years, 93 (48,7%) were male and 98(51,3%) were female. 142 (75,1%) lived in urban areas, 16 (8.9%) patients lived alone, 154 (86%) with the family and 9 (5%) requires support from a caregiver. At study entry, 143 (78.1%) were independent, 25 (13.7%) grade I, 12 (6.6%) grade 2 and 3(1.6%) grade 3. 42 patients (22.3%) have primary studies, 14 (7.5%) were in active employment, 11 (5.9%) unemployed and 146 (78.5%) were retired. Physical activity was high in 10 (5.5%) patients, 102 (56.4%) moderate/low and 69 (38.1%) were inactive. Comorbidities are listed in Table 1. 44.5% of the patients have received a previous line of treatment and 60 (31.6%) has received a previous stem cell transplant (SCT) at study visit. Laboratory and cytogenetic test were available in 189 patients at study entry. 25 (13.3%) have minimal residual disease (MRD) test available with 9.6% positive and 3.7% negative. 90 (47.6%) patients performed a cytogenetic abnormalities test at current treatment initiation, 39 (43.3%) with high risk and 51 (56.7%) with standard risk. ECOG at current treatment initiation was available in 89 patients, 23 (25.8%) ECOG 0, 56 (62.9%) ECOG 1 and 7 (7.9%) ECOG 2. In 190 patients Charlson Comorbidity Index was performed at current treatment initiation and 184 patients completed the TSQM questionnaire.

Prescribed regimens per line and main agent are listed in table 2. 41 (21,5%) patients received a fixed duration vs 150 (78,5%) continuous treatment strategy.

CONCLUSION: Based on this preliminary analysis in the MM eligible population, the majority of patients are under a continuous treatment strategy, are in early treatment lines and the current treatment received is based on monoclonal antibodies as main agent. Further analysis will be provided to determine treatment patterns per line and duration of treatment prescribed in real-life practice.

Keywords: multiple myeloma (MM); clinical characteristics, duration of treatment, fixed and continuous treatment, real-life practice.

Escalante:Janssen: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees.