Multiple MyelomaNCT02921828
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
An observational study of Multiple Myeloma, run by Celgene at 2 sites in 2 countries.
Trial summary
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 1,149 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Apr 2015to 10 Dec 2015
- 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: Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Who may be able to join
- Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Who cannot join
- N/A
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Local Institution - Japan
No City Provided, New Jersey, 00000
About this study
Official title: Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
- Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
- Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst
- Conditions
- Multiple Myeloma
- Keywords
- Pomalyst, Teratogenicity, bone marrow suppression, thromboembolism, peripheral neuropathy, infection, tumour lysis syndrome, somnolence, depressed level of consciousness, confusion, fatigue, dizziness, acute renal failure, heart failure, arrhythmia, interstitial pneumonia, hypersensitivity, hepatic function disorder, jaundice
- Medical subject headings
- Multiple Myeloma, Teratogenesis, Thromboembolism, Peripheral Nervous System Diseases, Infections, Tumor Lysis Syndrome, Sleepiness, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple myeloma patients who received Pomalyst | Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE)
Number of participants with adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start30 Apr 2015
- Primary completion10 Dec 2015
- Study completion10 Dec 2015
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 CelgeneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinshu Cho, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921828
- Sponsor's protocol ID
- NIS-Celgene-JP-PMS-002
- Status last verified
- Jun 2022
- First submitted
- 30 Sep 2016
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
- ClinicalTrials.gov ID
- NCT02921828
- Acronym / sponsor ID
- NIS-Celgene-JP-PMS-002
- Conditions
- Multiple Myeloma
- Keywords
- Pomalyst, Teratogenicity, bone marrow suppression, thromboembolism, peripheral neuropathy, infection, tumour lysis syndrome, somnolence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 10 Dec 2015 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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.
- Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
- Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple myeloma patients who received Pomalyst | – | –Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Key inclusion criteria (1 listed)
- Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse event (AE)
Time frame: 3 years
Number of participants with adverse events
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 5 Jul 2022.
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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.
Jinshu Cho study director
Celgene
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene at 2 sites in 2 countries.
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 1 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Japan. 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?
Adverse event (AE) (time frame: 3 years). 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 5 Jul 2022.