BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.
Study Type
OBSERVATIONAL
Enrollment
500
No Intervention
Local Institution
Shinjuku-ku, Tokyo, Japan
Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan
Time frame: Up to 72 weeks
Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan
immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process.
Time frame: Up to 72 weeks
Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 72 weeks
Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 72 weeks
Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 72 weeks
Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 72 weeks
Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 72 weeks
Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 72 weeks
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