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

NCT06163040 — Completed, 7 participants, Bristol-Myers Squibb

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

Registry	NCT06163040
Status	Completed
Study type	Observational
Enrollment	7 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Relapsed or Refractory Multiple Myeloma
Interventions	Elotuzumab in combination with pomalidomide and dexamethasone, Elotuzumab in combination with lenalidomide and dexamethasone (Drug)
Dates	start 2023-12-22, primary completion 2025-03-17, completion 2025-03-17, first posted 2023-12-08, last updated 2025-07-31
Locations	4 sites in Taiwan

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Treated with Elotuzumab in combination with pomalidomide and dexamethasone		Drug: Elotuzumab in combination with pomalidomide and dexamethasone
Treated with Elotuzumab in combination with lenalidomide and dexamethasone		Drug: Elotuzumab in combination with lenalidomide and dexamethasone

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)
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)

+Outcome measures

Primary outcomes

Number of participants with adverse events [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)]: Assessed according to NCI CTCAE v5.0
Number of participants with adverse events of special interest [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)]: Opportunistic infections including viral hepatitis and tuberculosis reactivation

Secondary outcomes

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 [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)]: Laboratory abnormality and/or adverse event

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country
Chang Gung Memorial Hospital- Chiayi	Chiayi City, Chiayi	Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Taiwan
National Taiwan University Hospital	Taipei	Taiwan
China Medical University Hospital	Taoyuan City	Taiwan

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb