Evaluating the safety of elotuzumab for treating multiple myeloma in Taiwan
Empliciti® (Elotuzumab) Post-Marketing Surveillance Study for Patients With Multiple Myeloma in Taiwan
This study is testing how safe a new treatment combining elotuzumab with other medications is for people in Taiwan who have relapsed or hard-to-treat multiple myeloma after trying other therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | elotuzumab |
| Locations | 4 sites (Chiayi City, Chiayi and 3 other locations) |
| Trial ID | NCT06163040 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the safety of elotuzumab when combined with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (RRMM) who have undergone at least two prior therapies. Additionally, it evaluates the safety of elotuzumab in combination with lenalidomide and dexamethasone for RRMM patients who have received one to three prior therapies. The study aims to gather real-world data on the safety profile of these treatment combinations in a Taiwanese population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of relapsed or refractory multiple myeloma who have received at least one prior therapy.
Not a fit: Patients who are contraindicated for treatment with elotuzumab or those participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of elotuzumab, potentially leading to improved treatment options for patients with multiple myeloma.
How similar studies have performed: Other studies have shown promising results with elotuzumab in treating multiple myeloma, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chiayi City, Chiayi and 3 other locations
- Chang Gung Memorial Hospital- Chiayi — Chiayi City, Chiayi, Taiwan (Recruiting)
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- China Medical University Hospital — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.