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

Richardson, Paul G.; Bensinger, William I.; Huff, Carol Ann; Costello, Caitlin; Lendvai, Nikoletta; Berdeja, Jesús G.; Anderson, Larry D.; Siegel, David S.; Jagannath, Sundar; Laubach, Jacob P.; Stockerl-Goldstein, Ketih; Knapp, Lisa L.; Kwei, Long; Clow, Fong; Graef, Thorsten; Bilotti, Elizabeth; Vij, Ravi

doi:10.1016/j.clml.2015.07.235

Cited by 2 publications

(4 citation statements)

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“…After administration, ibrutinib demonstrated rapid absorption and elimination, as previously observed [8]. Systemic exposure to ibrutinib, when coadministered with carfilzomib and dexamethasone, in patients with MM trended higher than that observed in MM patients receiving dexamethasone only (Figure 2).…”

Section: Pharmacokinetics/pharmacodynamicsmentioning

confidence: 48%

“…In patients previously exposed to . a PCYC-1111 was a phase 1/2, open-label, nonrandomized, multicenter study of ibrutinib with or without dexamethasone in relapsed or relapsed and refractory multiple myeloma; dexamethasone dose was 4 mg weekly [8].…”

Section: Discussionmentioning

confidence: 99%

“…Cohort 3a not opened based on PCYC-1111 outcomes noted with the inclusion of dexamethasone to study treatment [8].…”

Section: Assessmentsmentioning

confidence: 99%

“…In patients with relapsed or relapsed and refractory MM (RRMM) who had a median of four prior therapies, ibrutinib plus dexamethasone demonstrated durable clinical activity, with a clinical benefit rate (CBR) of 28%, a median progression-free survival (PFS) of 4.6 months, and sustained stable disease (>4 cycles) in 23% of patients [8]. Carfilzomib, a next-generation, selective, and irreversible PI, is approved for patients with MM who have been previously treated with multiple lines of therapy [9].…”

Section: Introductionmentioning

confidence: 99%

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

Chari

Larson

Holkova

et al. 2018

Leukemia & Lymphoma

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(2018) Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma, Leukemia & Lymphoma, 59:11, 2588-2594, DOI: 10.1080/10428194.2018 ABSTRACTThis 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/m 2 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. ARTICLE HISTORY

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Section: Pharmacokinetics/pharmacodynamicsmentioning

confidence: 48%

Section: Discussionmentioning

confidence: 99%

“…Cohort 3a not opened based on PCYC-1111 outcomes noted with the inclusion of dexamethasone to study treatment [8].…”

Section: Assessmentsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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