Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: No Intervention

• 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

Study Timeline

• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-29
• Study Start: 2018-01-01
• Primary Completion: 2018-06-18
• Study Completion: 2018-06-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-20

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

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Exclusion Criteria

• Not Applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MM patients receiving elotuzumab	No Intervention	Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites.

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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Shinjuku-ku, Tokyo, Japan