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Ixazomib in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Conference Correspondent

REMIX was a noninterventional, prospective, observational study conducted in France to evaluate the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRD) as a second-line or greater therapy in patients with relapsed/refractory multiple myeloma (RRMM). The study included 315 patients from 59 sites who were assessed every 3 months for 2 years followed by every 6 months according to standard clinical practice. Patients were enrolled through access to ixazomib via a compassionate use program (CUP) or via traditional market access to the drug (non-CUP). The total follow-up period ranged from 24 to 54 months.

The aim of the study was to measure any improvement in median progression-free survival following treatment with IRD in patients treated for RRMM. Secondary outcome measures included evaluation of the median overall survival rate at different time periods during treatment, response to the IRD regimen, and the safety and tolerability of the regimen. The study also examined the utilization of healthcare resources among this patient population. This interim analysis summarizes patient and disease characteristics at IRD initiation and at 30 months and ixazomib use and tolerance.

There were 178 patients in the CUP group and 137 in the non-CUP group. Among the total patient population (n = 315), 51% were male with a median age of 72 years, 51% were determined to be frail, and 8% were diagnosed with renal failure. The non-CUP patients had a median age of 74 years, and 57% were determined to be frail. Comorbidities were reported in 62% of patients, including 10% with diabetes, 9% with renal disease, and 7% with a solid tumor.

Patients had undergone 1 to 11 prior treatment regimens, with the majority (63%) having received 1 prior treatment; 18% of patients had received 2 prior treatments, and 19% of patients had received ≥3 prior treatments. Among the patients who had a history of previous treatments, 44% had undergone stem-cell transplantation, 93% had been treated with a proteasome inhibitor, and 63% had been treated with an immunomodulatory drug, 37 of which received lenalidomide.

The reasons for IRD initiation were biochemical (28%), clinical ± biochemical (57%) relapse, or other reasons (15%). In the CUP group, 166 patients were followed and received a median of 11 cycles. Ixazomib was associated with a 40% discontinuation rate (66 patients), 11% of which were because of adverse events (n = 18), and dose reduction occurred in 16% of patients. The most frequent adverse events included thrombocytopenia (25%), diarrhea (21%), asthenia (14%), neutropenia (13%), and nausea (10%). Serious adverse events occurred in 25.8% of patients; 2.8% of serious adverse events were determined to be associated with ixazomib treatment.

The conclusions from this real-world study suggest lenalidomide and dexamethasone are primarily prescribed in the elderly, following 1 to 2 previous therapy regimens, at a dose of 4 mg. The reported adverse events for the addition of ixazomib were consistent with the previously established safety profile. Further analyses will determine the impact on progression-free survival.


Reference

  • Abstract and Poster EP1036. EHA 2020. June 12, 2020. Ixazomib real-life-setting use in combination with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: REMIX, a prospective, non-interventional study.

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