Multiple Myeloma
Conditions
Brief summary
BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan | 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 | — |
| 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 Very good partial response (VGPR) 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 Progressive Disease (PD) 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 | — |
Countries
Japan
Outcome results
None listed