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

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

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.

Study Overview

• Status: Completed
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Elotuzumab in combination with pomalidomide and dexamethasone; Drug: Elotuzumab in combination with lenalidomide and dexamethasone

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei, Taiwan, 100229
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 40447
    • China Medical University Hospital
  • Chiayi
    • Chiayi City, Chiayi, Taiwan, 613
      • Chang Gung Memorial Hospital- Chiayi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated with Elotuzumab in combination with pomalidomide and dexamethasone	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)
Treated with Elotuzumab in combination with lenalidomide and dexamethasone	Drug: 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)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Actual): March 17, 2025
• Study Completion (Actual): March 17, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Enzyme Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Dexamethasone; Dexamethasone acetate; BB 1101; Pomalidomide; Elotuzumab
• Other Study ID Numbers: CA204-219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No