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NCT Number: NCT06163040

A Study to Evaluate the Safety of Empliciti® (Elotuzumab) When Treating 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.

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Key information

Conditions

Relapsed or Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital- Chiayi, Chiayi City, Chiayi, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 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

  2. Number of participants with adverse events of special interest

    Time frame: 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

  1. Number of participants with fungal infections

    Time frame: 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)

  2. Number of participants with reactivation of viral hepatitis

    Time frame: 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)

  3. Number of participants with other viral infection/reactivation

    Time frame: 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)

  4. Number of participants with tuberculosis infection/reactivation

    Time frame: 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)

  5. Number of participants with other opportunistic infections

    Time frame: 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)

  6. Number of participants with lymphopenia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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