A Global Treatment Standard in Multiple Myeloma (MM) Remains Elusive Despite Advances in Care over 15 years: First Results from INSIGHT MM, the Largest Global Prospective, Observational MM Study

Costello, Caitlin; Boccadoro, Mario; Usmani, Saad Z.; Chari, Ajai; Rifkin, Robert M.; Abonour, Rafat; Berdeja, Jesús G.; Cook, Gordon; Goldschmidt, Hartmut; Hungria, Vânia; Lee, Hans C.; Leleu, Xavier; Omel, Jim; Spencer, Andrew; Thompson, Michael A.; Vela‐Ojeda, Jorge; Zonder, Jeffrey A.; Puig, Noemí; Aguarón, Alfonso; Davies, Faith E.; Demers, Brittany; Ren, Kaili; Yu, Su; Skácel, Tomáš; Stull, Dawn Marie; Terpos, Evangelos

doi:10.1016/j.clml.2018.07.146

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“…Several other studies have investigated the benefit of IRd treatment in patients with MM in a real-world setting [ 20 – 30 ]. Our results add to the body of evidence from these studies, which have shown the effectiveness of IRd in a broad range of patients, including frail, older, and heavily pre-treated patients and those with advanced disease [ 21 , 23 , 25 , 28 – 30 ].…”

Section: Discussionmentioning

confidence: 99%

A prospective, multicenter, observational study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in Japan

Horigome,

Iino,

Harazaki

et al. 2023

Ann Hematol

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Real-world studies permit inclusion of a more diverse patient population and provide more information on the effectiveness of treatments used in routine clinical practice. This prospective, multicenter, observational study investigated the effectiveness and safety of ixazomib plus lenalidomide and dexamethasone (IRd) in 295 patients with relapsed/refractory multiple myeloma (RRMM) in routine clinical practice in Japan. Patients had a median age of 74 years, 80.0% were aged ≥ 65 years, 42.0% had received ≥ 3 lines of prior treatment, and 28.5% were “frail” according to the International Myeloma Working Group frailty score. After a median follow-up of 25.0 months, median progression-free survival (PFS) was 15.3 (95% CI 12.4–19.5) months, while median overall survival was not reached. The overall response rate was 53.9%, and 31.5% of patients had a very good partial response or better. In the subgroup analysis, median PFS was better in patients with 1 versus 2 or ≥ 3 lines of prior treatment (29.0 vs 19.2 or 6.9 months) and paraprotein versus clinical relapse (16.0 vs 7.9 months), but median PFS was not notably affected by frailty score or age group. Dose adjustment was more frequent among patients aged > 75 years, especially early after IRd treatment initiation. Treatment-emergent adverse events (TEAEs) of any grade occurred in 84.4% of patients and 24.7% of patients discontinued treatment due to TEAEs; no new safety concerns were found. These findings suggest that oral IRd triplet regimen is an effective and tolerable treatment option for RRMM patients in real-world settings outside of clinical trials.ClinicalTrials.gov identifier: NCT03433001; Date of registration: 14 February 2018.

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