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

Recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: Elotuzumab in combination with pomalidomide and dexamethasone; Drug: Elotuzumab in combination with lenalidomide and dexamethasone

• Registration Number: NCT06163040
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Study Start: 2023-12-22
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated with Elotuzumab in combination with pomalidomide and dexamethasone	Elotuzumab in combination with pomalidomide and dexamethasone	-
Treated with Elotuzumab in combination with lenalidomide and dexamethasone	Elotuzumab in combination with lenalidomide and dexamethasone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

China Medical University Hospital; 🇨🇳 Taoyuan City, Taiwan

Chang Gung Memorial Hospital- Chiayi; 🇨🇳 Chiayi City, Chiayi, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan