An Open-label study of Ibrutinib in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma

Pharmacyclics Switzerland GmbH0 个研究点目标入组 125 人2016年3月23日

概览

暂无简介。

注册库

who.int

开始日期

2016年3月23日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

•1\. Subjects with MM who have received 2\-3 prior lines of therapy and
•have demonstrated disease progression since the completion of the most
•recent treatment regimen.
•2\. Measurable disease defined by at least ONE of the following:
•Serum monoclonal protein (SPEP) \=1 g/dL
•Urine monoclonal protein (UPEP) \=200 mg by 24 hour urine electrophoresis
•3\. Adequate hematologic function
•4\. Adequate hepatic and renal function
•5\. Prothrombin time (PT)/ International normal ratio (INR) \=1\.5 x upper limit of normal (ULN)
•and PTT (activated partial thromboplastin time \[aPTT]) \=1\.5 x ULN

•1\. Primary refractory disease defined as nonresponsive in patients who have never achieved a minimal response or better with any therapy.
•2\. History of plasma cell leukemia, primary amyloidosis, POEMS syndrome within 12 months prior to first administration of study treatment.
•3\. Recent prior chemotherapy
•4\. Prior exposure to BTK inhibitors
•5\. Refractory or non\-responsive to prior PI therapy (bortezomib or carfilzomib)
•6\. History of hypersensitivity reactions to prior bortezomib, to boron, mannitol or nitrogen.
•7\. History of other malignancies
•8\. Peripheral neuropathy Grade \=2 or Grade 1 with pain at Screening
•9\. Prior allogeneic stem cell transplant
•10\. Recent infection requiring systemic treatment that was completed \<7 days before the first administration of study treatment and/or uncontrolled active