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

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163040
• Other study ID #: CA204-219
• Status: Recruiting
• Start date: December 22, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• Elotuzumab in combination with pomalidomide and dexamethasone
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
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)

Locations

Country	Name	City	State
Taiwan	Local Institution - 0002	Chiayi City	Chiayi
Taiwan	Local Institution - 0003	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Local Institution - 0004	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls