Abstract
Ixazomib-Revlimid-Dexamethasone is an all-oral treatment protocol for multiple myeloma with a manageable tolerability profile which was available through a named patient program for Hungarian patients from December 2015 to April 2017. We analyzed the clinical characteristics and survival of 77 patients treated at 7 centers within this program. The majority of patients responded, we found complete response in 9, very good partial response in 8, partial response in 32, minor response or stable disease in 13 and progressive disease in 11 patients. Progression free survival was 11.4 months. There was a trend of longer progression free survival in those with 1 vs. >1 prior treatment, with equally good effectivity in standard risk and high risk cytogenetic groups. The adverse events were usually mild, none leading to permanent drug interruptions. There were 5 fatalities: 3 infections and 2 pulmonary embolisms. Our real word data support the use of Ixazomib-Revlimid-Dexamethasone as a highly effective and well tolerated oral treatment protocol for relapsed myeloma.
Highlights
Patients were younger than the usual myeloma patient at this stage
Except for one patient, all had both IMiD and proteasome inhibitor (PI) pretreatment in various combinations depending on the era when it was initiated
In 3 patients, IRD triplet treatment was stopped prematurely due to logistic reasons: 2 patients (1 in PR and 1 in VGPR) stopped ixazomib and carried on lenalidomide maintenance only, and the third with stable disease switched to a new protocol
Summary
Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary It was 15 years ago that introduction of the intravenous proteasome inhibitor (PI) bortezomib revolutionized the treatment of multiple myeloma, soon followed by the approval of lenalidomide for the same disease. Ixazomib is the first oral PI that showed high efficacy and safety for the treatment of relapsed and/or refractory multiple myeloma in the TOURMALINE MM1 trial in combination with lenalidomide and dexamethasone (IRD) leading to its FDA and subsequent EMA approval. Clinical trials are significantly different from real world use of therapies in many aspects including less rigorous patient selection, greater flexibility with dosing and country specific funding restrictions. Protocol treatment continued until progression or death; several patients are still taking the medications
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