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This observational study aimed to assess the safety of elotuzumab when used in combination with pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma (RRMM) in participants who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The study will also assess the safety of elotuzumab when used in combination with lenalidomide and dexamethasone in RRMM participants who had received one to three prior therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with Elotuzumab in combination with pomalidomide and dexamethasone |
| ||
| Treated with Elotuzumab in combination with lenalidomide and dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elotuzumab in combination with pomalidomide and dexamethasone | Drug | Participants who received elotuzumab in combination with pomalidomide and dexamethasone for RRMM and had ≥2 prior lines of therapy (including lenalidomide and a proteasome inhibitor) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Assessed according to NCI CTCAE v5.0 | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Number of participants with adverse events of special interest | Opportunistic infections including viral hepatitis and tuberculosis reactivation | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with fungal infections | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | |
| Number of participants with reactivation of viral hepatitis |
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Inclusion Criteria:
Exclusion Criteria:
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Adult (≥ 18 years of age) patients who have a confirmed diagnosis of RRMM, who 1) have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, and are planning to receive Empliciti in combination with pomalidomide and dexamethasone, or 2) have received one to three prior therapies and are planning to receive Empliciti in combination with lenalidomide and dexamethasone
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital- Chiayi | Chiayi City | Chiayi | 613 | Taiwan | ||
| Kaohsiung Medical University Chung-Ho Memorial Hospital |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Elotuzumab in combination with lenalidomide and dexamethasone | Drug | Participants who received elotuzumab in combination with pomalidomide and dexamethasone for RRMM and had ≥2 prior lines of therapy (including lenalidomide and a proteasome inhibitor) |
|
| 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Number of participants with other viral infection/reactivation | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Number of participants with tuberculosis infection/reactivation | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Number of participants with other opportunistic infections | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Number of participants with lymphopenia | Laboratory abnormality and/or adverse event | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) |
| Kaohsiung City |
| 80756 |
| Taiwan |
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
| China Medical University Hospital | Taoyuan City | 40447 | Taiwan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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| ID | Term |
|---|---|
| C546027 | elotuzumab |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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