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Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma. 2018
Ajai Chari, and
Sarah Larson, and
Beata Holkova, and
Robert F Cornell, and
Cristina Gasparetto, and
Chatchada Karanes, and
Jeffrey V Matous, and
Ruben Niesvizky, and
Jason Valent, and
Matthew Lunning, and
Saad Z Usmani, and
Larry D Anderson, and
Lipo Chang, and
Yihua Lee, and
Yvonne Pak, and
Zeena Salman, and
Thorsten Graef, and
Elizabeth Bilotti, and
Saurabh Chhabra
a Icahn School of Medicine at Mount Sinai , Tisch Cancer Institute , New York , NY , USA.
This phase 1, dose-finding study investigated ibrutinib and carfilzomib ± dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma (≥2 lines of therapy including bortezomib and an immunomodulatory agent). Of 43 patients enrolled, 74% were refractory to bortezomib and 23% had high-risk cytogenetics. No dose-limiting toxicities were observed. The recommended phase 2 dose was ibrutinib 840 mg and carfilzomib 36 mg/m2 with dexamethasone. The most common ≥ grade 3 (>10%) treatment-emergent adverse events were hypertension, anemia, pneumonia, fatigue, diarrhea, and thrombocytopenia. Overall response rate was 67% (very good partial response, 21%; stringent complete response, 2%), with an additional 9% minimal response. Median progression-free survival was 7.2 months and was not inferior in refractory nor high-risk patients. Median overall survival was not reached. Ibrutinib plus carfilzomib demonstrated encouraging responses with a manageable safety profile in this advanced population.
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Zhonghua nei ke za zhi,
