An OpenLabel Treatment Use Protocol for Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent

Janssen Pharmaceutical K.K.0 个研究点目标入组 5 人开始时间: 2017年6月23日最近更新: 2023年10月17日

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•Subject must be at least 18 years of age
•- Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria: Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal to [>=] 2
•cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who
•discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months) OR Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one
•- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
•- A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening
•- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

•- Ever enrolled in a nother daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab
•- Subject receives any other antimyeloma
•therapy while receiving daratumumab
•- Enrolled in another interventional clinical study with therapeutic intent
•- Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
•- Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
•- Prior exposure to any antiCD38 monoclonal antibody

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