ELISA in Relapsed/Refractory MM

其他名称：PF-06863135

Subcutaneously injected study drug, usually into the abdomen or lower stomach. Each vial of elranatamab contains a sufficient amount of product to ensure an extractable volume of 1.9 mL at a concentration of 40 mg/mL. The dosing is as follows: * Cycle 1 Day 1: 12 mg/0.3 mL; * Cycle 1 Day 4: 32 mg/0.8 mL; * Cycle 1 Day 8, 15, 22: 76 mg/1.9 mL; * Cycles 2-6, Day 1 and 15: 76 mg/1.9 mL; * Cycles 7-12, Day 1: 76 mg/1.9 mL; * Cycles 13-24, Day 1 of Cycles 13, 16, 19, 22 (every 12 weeks): 76 mg/1.9 mL

其他名称：SAR650984、Isatuximab irfc

Isatuximab (SAR650984) is an IgG1 derived monoclonal antibody binding selectively the human CD38 membrane protein. Subcutaneously (SC) injected study drug with each vial containing 140 mg/mL (1400 mg/10mL) isatuximab. Isatuximab SC will be injected using the investigational OBDS and in the following doses: * Cycles 2-6, Day 1 and 15: 1400 mg/10 mL * Cycles 7-12, Day 1: 1400 mg/10 mL * Cycles 13-24, Day 1 of Cycles 13, 16, 19, 22 (every 12 weeks): 1400 mg/10 mL

其他名称：On Body Delivery System (Device)、OBDS、Isatuximab Subcutaneous Injection Device (On Body Delivery System, OBDS)、Isatuximab SC Wearable Injection System

The On Body Delivery System (OBDS) also called Isatuximab SC Wearable Injection System, is a sterile, single-use, disposable, elastomeric, user-filled investigational medical device. The OBDD has a reservoir for the drug product (isatuximab). A self-contained, integrated needle (with manual insertion and automatic retraction mechanism) is provided within the OBDS. The OBDS will be used to inject isatuximab each time the participant receives isatuximab in this study. Study drug administration will be done by trained medical professionals in the clinic. The OBDS device will be prepared by the medical professional, placed on the abdomen using the adhesive (sticky) pads that are on the device, the study drug (isatuximab) will be injected, and then the device will be removed.