Multiple MyelomaNCT03660072
Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in South Korea.
Trial summary
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Non-Interventional
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2022to 28 Oct 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean participants with Multiple Myeloma
Who may be able to join
- Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)
Who cannot join
- Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea
- Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
- Conditions
- Multiple Myeloma
- Being tested
- Non-Interventional
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Empliciti combination therapy | Adult patients with a confirmed diagnosis of MM who have received, are currently receiving, or will begin Empliciti combination therapy Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE's and SAE's
Measured: 24 Months
Secondary outcomes (2)
Overall response of Empliciti treatment with lenalidomide and dexamethasone
Measured: 24 Months
Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start31 Jan 2022 (estimated)
- Primary completion28 Oct 2022 (estimated)
- Study completion28 Oct 2022 (estimated)
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Enrolment
- 0 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
- NCT03660072
- Sponsor's protocol ID
- CA204-176
- Status last verified
- May 2022
- First submitted
- 20 Aug 2018
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03660072
- Acronym / sponsor ID
- CA204-176
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (estimated)
- Primary completion
- 28 Oct 2022 (estimated)
- Study completion
- 28 Oct 2022 (estimated)
- First posted
- 6 Sep 2018 (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 study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empliciti combination therapy | – | Other: Non-InterventionalAdult patients with a confirmed diagnosis of MM who have received, are currently receiving, or will begin Empliciti combination therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean participants with Multiple Myeloma
Key inclusion criteria (1 listed)
- Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)
Key exclusion criteria (3 listed)
- Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea
- Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Empliciti combination therapy |
Primary outcome
Incidence of AE's and SAE's
Time frame: 24 Months
2 secondary outcomes
Overall response of Empliciti treatment with lenalidomide and dexamethasone
Time frame: 24 Months
Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone
Time frame: 24 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in South Korea.
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 1 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: withdrawn, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of AE's and SAE's (time frame: 24 Months). 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 27 May 2022.