Introduction: Despite significant advancement in novel agents and combination therapies, multiple myeloma remains incurable. For patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for stem cell transplant, treatment aims to achieve deep and durable responses, delay disease progression, and prolong survival. As treatment landscape evolves, up-to-date real-world data are essential to understand current treatment practices, clinical outcomes, and the associated healthcare burden. This study evaluated real-world treatment patterns, clinical outcomes, and healthcare resource utilization (HRU) for non-transplant NDMM patients in France.

Methods: This retrospective cohort study utilized the data from the French National Health Data System (SNDS), which covers 99% of the French population. Adult patients diagnosed with MM (ICD-10 code C90) who initiated systemic therapy between January 2015 and December 2022 and did not undergo transplant during first-line (1L) therapy were included. Patients were followed until the earliest of death or end of data availability (December 2023) and required to have continuous records for at least 12 months before and after 1L initiation. Treatment pattern was summarized by number and proportion of patients receiving each regimen at 1L from 2015 to 2022. Clinical outcomes, including time to treatment discontinuation (TTD), time to next treatment (TTNT), and overall survival (OS) were assessed using Kaplan-Meier methods. HRU and costs were described before and after 1L initiation.

Results: Among 28,471 NDMM patients who received systemic treatment, 21,978 (77%) patients did not undergo transplant at 1L. The mean (standard deviation [SD]) age was 75.2 (9.9) years, 54% were male. Renal impairment (24.1%) was the most common CRAB symptom reported in hospital records, followed by bone lesions (13.0%) and anemia (13.0%). The number of non-transplant patients initiating systemic therapy for MM significantly increased by 94% from 1816 in 2015 to 3515 in 2022.

During the study period, the 1L treatment for non-transplant patients was predominately doublets, with bortezomib-dexamethasone (Vd; 24.2%) and lenalidomide-dexamethasone (Rd; 18.2%) being the most prevalent 1L treatment before triplets became available. Prior to the reimbursement of daratumumab-lenalidomide-dexamethasone (DRd) in 2021, the adoption of bortezomib-lenalidomide-dexamethasone (VRd) substantially increased from 3% (2015) to 31% (2020). Following DRd reimbursement, its use rapidly grew from <2% (pre-2020) to 32.3% (2021) and 44.1% (2022), while the use of VRd decreased to 12.3% in 2021 and 3.8% in 2022. Despite daratumumab-bortezomib-melphalan-prednisone (DVMp) receiving high evaluation and reimbursement recommendation from the France's Transparency Committee in 2020, it was rarely used in France (<1%).

During a median follow up of 27.7 months, patients received an average of 2.75 lines of therapy including 1L. Median (95% confidence interval [CI]) 1L TTD was 7.16 (6.93, 7.33) months, much shorter than those reported in clinical trials. Median (95% CI) OS from 1L initiation was 50.6 (49.41; 51.75) months. OS deteriorated substantially with subsequent lines of therapy: 43.2 (42.0, 45.6) months for 2L, 26.4 (24.0, 27.6) months for 3L, and 14.4 (13.2, 16.8) months for 4L.

Prior to 1L initiation, the mean (SD) number of visits per-patient-per-month (PPPM) was 0.13 (0.09) to hospital, 0.1 (0.06) to emergency rooms, and 0.71 (0.64) to outpatient clinics. These frequencies increased to 0.33 (0.28), 0.11 (0.06), and 2.9 (1.03) respectively after 1L initiation. The mean (SD) PPPM healthcare costs increased substantially from €1315 (€1759) before to €9774 (€7113) after 1L initiation.

Conclusions: Since 2015, the treatment paradigm for non-transplant NDMM in France has shifted from doublets to triplets, with VRd being the standard of care even without reimbursement before 2021 when anti-CD38 triplet, DRd, became available and increasingly adopted. Despite these advancements, the outcomes of 1L treatment remained suboptimal with short median TTD and median OS under 5 years. The substantial increase in HRU and costs post-1L initiation further emphasizes a significant economic burden. These findings highlight the critical necessity for more effective and durable treatment options, such as quadruplets, to improve patient outcomes and alleviate the economic burden associated with non-transplant NDMM.

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2025
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