Unravelling Transplant-Ineligible Newly Diagnosed Multiple Myeloma Treatment in Real-World Practice in Spain. Carinae Study

Introduction: There is little data regarding real-world treatment patterns and outcomes of transplant-ineligible newly diagnosed multiple myeloma patients (TIE-NDMM) in Spain. In recent years, several treatment regimens have been authorized as effective options for TIE-NDMM, providing patients with better outcomes and quality of life, as evidenced in clinical trials (Mateos et al. Lancet 2020). However, the contribution of incorporating these new treatments into the daily therapeutic arsenal has not been widely explored.

Methods: Observational, ambispective, multicenter ongoing study on TIE-NDMM patients who started antineoplastic treatment in the context of daily clinical practice in Spanish hospitals. Group A: started treatment with a combination of ≥2 drugs, between Sep/01/2018 and Aug/31/19. Group B: started treatment with daratumumab in combination with bortezomib, melphalan and prednisone (DVMP group), between Sep/01/19 and Nov/30/20. Here, we present the efficacy and safety outcomes obtained in the second interim analysis after ≈24-month study initiation.

Results: 117 patients were recruited, and 108 were evaluable for efficacy in this interim analysis (group A n=51; group B n=57). No significant differences were observed in basal clinical and demographics characteristics between groups (table 1): mean age 76.9 years; male (53.7%); cardiopathy 28.7%; renal failure 25%; pulmonary obstructive disease 8.3%; peripheral neuropathy 2.8%; median ECOG PS 1; most common myeloma type was IgG (49.5%); 13.9% had a high-risk cytogenetic profile, defined by one of the following alterations: t(4;14), t(14;16) and del 17p13; plasmacytoma 24.3 %. More than 90% of the patients in group A started treatment with schemes based on bortezomib, lenalidomide, or both. Median follow-up was 36.3 versus 23.3 months for groups A and B, respectively, since the initiation of first-line treatment (p<0,0001). Probably in relation to the different follow-ups, the median PFS for Group A was 32.78 months and not reached for Group B (p=0,1129), figure 1. The progression rate at 18 months was 27.5% and 10.5% for Group A and B respectively (p=0,0238). Rates of ≥VGPR and ≥CR, were 60% and 30% in Group A whilst 75.4% and 33.3% in Group B, table 2. 36.9% of the patients showed adverse drug reactions (ADR) related to the first-line treatment during the prospective period. 10.6% of the reported ADRs were serious with no significant differences between groups. No unexpected ADRs were observed. Additional data will be presented at the Congress.

Conclusions: In this interim analysis, a significant clinical benefit has been identified in patients treated with DVMP, with improved PFS indicators vs. other treatment alternatives. Along with the deeper hematological responses observed, we expect this benefit to be consolidated in the final PFS analysis of the Carinae study. These real-world practice data continue to support the choice of daratumumab regimens in frontline TIE-NDMM patients.