A phase 2, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma

Celgene Corporation0 个研究点目标入组 140 人2017年12月4日

适应症Relapsed and Refractory Multiple Myeloma MedDRA version: 21.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864 MedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851 Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Relapsed and Refractory Multiple Myeloma
发起方: Celgene Corporation
入组人数: 140
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2017年12月4日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Celgene Corporation

入排标准

入选标准

•Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
•1\. Subject is \= 18 years of age at the time of signing the informed consent form (ICF).
•2\. Documented diagnosis of multiple myeloma
•\- Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
•\- Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
•\- Must have received a proteasome inhibitor, an immunomodulatory agent and an anti\-CD38 antibody.
•\- Must be refractory to the last treatment regimen. Refractory is defined as documented progressive disease during or within 60 days (measured from the last dose) of completing treatment with the last anti\-myeloma drug regimen before study entry.
•3\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\.
•4\. Subjects must have measurable disease, including at least one of the criteria below:
•\- Serum M\-protein greater or equal to 1\.0 g/dL

排除标准

•The presence of any of the following will exclude a subject from enrollment:
•1\. Subjects with known central nervous system involvement with myeloma.
•2\. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Note: this criterion does not apply to subjects undergoing retreatment unless Grade 4 neurotoxicity was observed following prior treatment with bb2121\).
•3\. Subjects with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
•4\. Subjects with solitary plasmacytomas or non\-secretory myeloma without other evidence of measurable disease.
•5\. Inadequate hepatic function defined by AST and/or ALT \> 2\.5 × upper limit of normal (ULN) and total bilirubin \> 1\.5 × ULN (unless due to Gilbert’s syndrome and direct bilirubin is \= 1\.5 x ULN).
•6\. Inadequate renal function defined by CrCl \= 45 ml/min using Cockcroft\-Gault equation.
•7\. International ratio (INR) or partial thromboplastin time (PTT) \> 1\.5 × ULN, or history of Grade \=2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anti\-coagulants (eg, warfarin, low molecular weight heparin, or Factor Xa inhibitors).
•8\. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \< 1000 cells/mm3 in the absence of growth factor support (filgrastim within 7 days or peg\-filgrastim within 14 days of screening) and platelet count \< 50,000 mm3 in the absence of transfusion support (platelet transfusion within 7 days of screening).
•9\. Echocardiogram or MUGA with left ventricular ejection fraction \< 45%.