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BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM patients receiving elotuzumab | Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at healthcare facilities in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Shinjuku-ku | Tokyo | 162-0822 | Japan |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |