New approaches to targeting the bone marrow microenvironment in multiple myeloma

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.

Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma.

Paul G. Richardson, MD1*, William I. Bensinger, MD2, Carol Ann Huff, MD3, Caitlin L. Costello, MD4, Nikoletta Lendvai, MD, PhD5,6, Jesus G. Berdeja, MD7, Larry D. Anderson, Jr. MD, PhD8, David S. Siegel, MD, PhD9, Sundar Jagannath, MD10, Jacob P. Laubach, MD1, Keith E. Stockerl-Goldstein, MD11, Lisa Knapp12, Long Kwei, PhD12, Fong Clow, ScD12, Thorsten Graef, MD, PhD12, Elizabeth Bilotti, MSN12, Ravi Vij, MD11

Ibrutinib in combination with low-dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: results from a multicenter phase 2 trial

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Ibrutinib in combination with low-dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: results from a multicenter phase 2 trial