PHASE 2 STUDY OF LINVOSELTAMAB IN PATIENTS WITH SMOLDERING MULTIPLE MYELOMA AT HIGH RISK OF PROGRESSION TO MULTIPLE MYELOMA - R5458-ONC-2256

Regeneron Pharmaceuticals Inc.0 个研究点目标入组 40 人开始时间: 2023年8月3日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•High-risk SMM diagnosis within 5 years of study enrollment, Eastern Cooperative Oncology Group (ECOG) performance status =1, Adequate hematologic and hepatic function, as described in the protocol, Estimated glomerular filtration rate =30 mL/min/1.73 m^2

•Evidence of myeloma defining events *SLiM CRAB, as described in the protocol *SLiM (greater than or equal to Sixty percent clonal plasma cells in the bone marrow, involved/uninvolved free Light chain ratio of =100 with the involved free light chain (FLC) being =100 mg/L, MRI with >1 focal lesion) CRAB (hyperCalcemia, Renal insufficiency, Anemia, or lytic Bone lesions), Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma, Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol, Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug, Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient, NOTE: Other protocol defined inclusion/exclusion criteria apply

发起方

Regeneron Pharmaceuticals Inc.