Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- NCT02976493
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study
Exclusion Criteria
- Not Applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria Up to 72 weeks Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria Up to 72 weeks Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria Up to 72 weeks Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria Up to 72 weeks Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan Up to 72 weeks Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria Up to 72 weeks Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan Up to 72 weeks 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.
Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria Up to 72 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution🇯🇵Shinjuku-ku, Tokyo, Japan