Relapsed or Refractory Multiple MyelomaNCT06163040
A Study to Evaluate the Safety of Empliciti® (Elotuzumab) When Treating Patients With Multiple Myeloma in Taiwan
An observational study of Relapsed or Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 4 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Elotuzumab in combination with pomalidomide and dexamethasone and Elotuzumab in combination with lenalidomide and dexamethasone
- How many people
- 7 participants
- Where
- 4 sitesTaiwan
- Study dates
- 22 Dec 2023to 17 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Chang Gung Memorial Hospital- Chiayi
Chiayi City, Chiayi, 613
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
National Taiwan University Hospital
Taipei, 100229
China Medical University Hospital
Taoyuan City, 40447
About this study
Official title: 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.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Elotuzumab in combination with pomalidomide and dexamethasone, Elotuzumab in combination with lenalidomide and dexamethasone
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elotuzumab in combination with pomalidomide and dexamethasoneDrug
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 dexamethasoneDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Treated with Elotuzumab in combination with pomalidomide and dexamethasone | Not described Receives: Drug: Elotuzumab in combination with pomalidomide and dexamethasone | |
| Treated with Elotuzumab in combination with lenalidomide and dexamethasone | Not described Receives: Drug: Elotuzumab in combination with lenalidomide and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Assessed according to NCI CTCAE v5.0
Measured: 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
Measured: 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 outcomes (6)
Number of participants with fungal infections
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start22 Dec 2023
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163040
- Sponsor's protocol ID
- CA204-219
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empliciti® (Elotuzumab) Post-Marketing Surveillance Study for Patients With Multiple Myeloma in Taiwan
- ClinicalTrials.gov ID
- NCT06163040
- Acronym / sponsor ID
- CA204-219
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with Elotuzumab in combination with pomalidomide and dexamethasone | – | Drug: Elotuzumab in combination with pomalidomide and dexamethasone |
| Treated with Elotuzumab in combination with lenalidomide and dexamethasone | – | Drug: Elotuzumab in combination with lenalidomide and dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elotuzumab in combination with pomalidomide and dexamethasoneParticipants who received elotuzumab in combination with pomalidomide and dexamethasone for RRMM and had ≥2 prior lines of therapy (including lenalidomide and a proteasome inhibitor) | Drug | Treated with Elotuzumab in combination with pomalidomide and dexamethasone |
| Elotuzumab in combination with lenalidomide and dexamethasoneParticipants who received elotuzumab in combination with pomalidomide and dexamethasone for RRMM and had ≥2 prior lines of therapy (including lenalidomide and a proteasome inhibitor) | Drug | Treated with Elotuzumab in combination with lenalidomide and dexamethasone |
Primary outcome
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
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.