Pilot Study of Ixazomib Plus Dexamethasone in High-Risk Smoldering Myeloma
Posted: Thursday, September 12, 2019
Patients with a precursor stage of multiple myeloma seem to tolerate treatment with ixazomib and dexamethasone, with low rates of disease progression, according to Sham Mailankody, MBBS, of the Memorial Sloan Kettering Cancer Center, New York, and colleagues. The oral proteasome inhibitor ixazomib is prescribed with dexamethasone for the second-line treatment of multiple myeloma, but it had heretofore not been tested in the context of smoldering multiple myeloma. Study results were presented at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 8051).
In this open-label, single-arm pilot study, 14 patients with high-risk smoldering multiple myeloma were treated with ixazomib and dexamethasone over a median follow-up of 17 months. The patients were mostly men (71%), with a median age of 65 years. The prespecified threshold for efficacy was the best overall response rate of 75%.
At data cutoff, the prespecified threshold for efficacy was not met, with nine patients having achieved an objective response. A median of 17 cycles of treatment had been completed, and 10 patients were still undergoing treatment. A total of four patients discontinued treatment (two had serologic disease progression, and two had toxicity and comorbidity unrelated to treatment). No patients experienced progression to multiple myeloma.
Common adverse events with the regimen included grade 1 gastrointestinal events, grade 3 lung infection, grade 2 acute kidney injury, and one case of grade 1 fatigue that the researchers thought might be related to treatment.
“These results support further evaluation of ixazomib/dexamethasone alone and in combination with other agents as treatment for patients with high-risk smoldering multiple myeloma,” the authors concluded.
Disclosure: The disclosure information for study authors can be found at coi.asco.org.
