An open-label, multi-center, expanded treatment protocol of oral panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and relapsed and refractory multiple myeloma

ovartis Pharma Services AG0 个研究点目标入组 200 人开始时间: 2015年2月13日最近更新: 2016年6月13日

适应症

试验速览

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•- Patient with diagnosis of multiple myeloma, based on IMWG definitions, that is relapsed or relapsed and refractory to at least two prior regimens including bortezomib and an immunomodulatory agent.
•a. Relapsed, defined by disease that recurred in a patient that responded under at least two prior regimens including bortezomib and an immunomodulatory agent, by reaching a MR or better, and had not progressed under current therapy or up to 60 days of last dose of this therapy. Patients previously treated with bortezomib are eligible.
•b. Relapsed-and-refractory to a therapy, provided that patient meets both conditions:
•patient has relapsed to at least two prior regimens including bortezomib and an immunomodulatory agent
•and patient was refractory to at least two prior regimens including bortezomib and an immunomodulatory agent by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last
•dose. Patients previously treated with bortezomib are eligible even if they are deemed refractory.
•- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2
•- Absolute neutrophil count (ANC) = 1.0 x 109 /L
•- Platelet count = 100 x 109 /L
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 125

•- Patient has shown intolerance or has any contraindications to bortezomib, dexamethasone or panobinostat
•- Patient is refractory to panobinostat
•- Patient has grade = 2 peripheral neuropathy
•- Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted)
•- Patient requires medication with a risk of prolonging the QT interval or inducing Torsades de pointes

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