A Study to Evaluate the Safety of Empliciti® (Elotuzumab) When Treating Patients With Multiple Myeloma in Taiwan

Study Overview
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Brief Summary
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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.

Official Title
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Empliciti® (Elotuzumab) Post-Marketing Surveillance Study for Patients With Multiple Myeloma in Taiwan

Conditions
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Relapsed or Refractory Multiple Myeloma

Intervention / Treatment
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* Drug: Elotuzumab in combination with pomalidomide and dexamethasone
* Drug: Elotuzumab in combination with lenalidomide and dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Confirmed diagnosis of RRMM Received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor Planning to receive elotuzumab in combination with pomalidomide and dexamethasone at physician's medical judgement OR Age ≥ 18 years Confirmed diagnosis of RRMM Received one to three prior therapies Planning to receive elotuzumab in combination with lenalidomide and dexamethasone at physician's medical judgement Exclusion Criteria: Participants with therapeutic indications for which elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone has not been approved in Taiwan Participants who are contraindicated for treated with elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone (as described in the Taiwan label) Participants who participate in other interventional clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with Elotuzumab in combination with pomalidomide and dexamethasone<br> | Drug: Elotuzumab in combination with pomalidomide and dexamethasone<br>* 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)<br>|
| Treated with Elotuzumab in combination with lenalidomide and dexamethasone<br> | Drug: Elotuzumab in combination with lenalidomide and dexamethasone<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) |