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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976493
• Other study ID #: CA204-179
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 18, 2018

Study information

• Verified date: August 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 18, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Japan	Local Institution	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan		Up to 72 weeks
Primary	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.	Up to 72 weeks
Primary	Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria		Up to 72 weeks
Primary	Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria		Up to 72 weeks
Primary	Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria		Up to 72 weeks
Primary	Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria		Up to 72 weeks
Primary	Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria		Up to 72 weeks
Primary	Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria		Up to 72 weeks

External Links

•   Investigator Inquiry Form