Multiple MyelomaNCT02556905
A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea
An observational study of Multiple Myeloma, run by Celgene at 25 sites in South Korea.
Trial summary
The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- REVLIMID® and Dexamethasone
- Type of treatment
- Pill or oral medicine
- How many people
- 624 participants
- Where
- 25 sitesSouth Korea
- Study dates
- 9 Mar 2011to 30 Nov 2016
- 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: All Korean patients who are intended to be treated with REVLIMID® and must be registered in risk management program according to the approved package insert.
Who may be able to join
- Korean male or female who are diagnosed with Multiple Myeloma
- In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®
- Patients who are registered for Risk Management Program of Celgene
Who cannot join
- There's no exclusion criteria
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
South Korea25 sites
Hallym University Sacred Heart Hospital
Anyang, 14068
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 14584
Inje University Busan Paik Hospital
Busan, 47392
Inje University Haeundae Paik Hospital
Busan, 48108
Dong-a University Medical Center
Busan, 49201
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Kyungpook National University Hospital
Daegu, 41954
Chungnam National University Hospital
Daejeon, 35015
Hwasun Chonnam National University Hospital
Hwasun-gun, 58128
Chonbuk National University Hospital
Jeonju, 54907
Inje University Sanggye Paik Hospital
Seoul, 01757
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Konkuk University Hospital
Seoul, 05030
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Boramae Medical Center
Seoul, 07061
Ewha Womans University Mokdong Hospital
Seoul, 07985
Korea University Guro Hospital
Seoul, 08308
Ulsan University Hospital
Ulsan, 44033
Wonju Severance Christian Hospital
Wŏnju, 26426
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: REVLIMID® Drug Use Examination
The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.
The patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.
Read more
Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.
REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug.
It is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.
- Conditions
- Multiple Myeloma
- Being tested
- REVLIMID®, Dexamethasone
- Keywords
- Multiple Myeloma, Revlimid, Lenalidomide, Observational, Korea, Post Marketing Surveillance[PMS]
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVLIMID®Drug
The recommended starting dose of REVLIMID® is 25mg/day with water orally administered as a single 25mg capsule on Days 1-21 of repeated 28-day cycles. Dose can be adjusted upon the clinical laboratory result.
DexamethasoneDrug
The recommended dose of dexamethasone is 40mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the 4 cycle of therapy and then 40mg/day orally on Days 1-4 every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Korean patients | All Korean patients intended to be treated with REVLIMID® according to the approved package insert Receives: Drug: REVLIMID®; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Number of participants with adverse events
Measured: Up to 6 years
Secondary outcomes (1)
Overall response rate
Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start9 Mar 2011
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
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
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miran Moon, Study director, Celgene Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556905
- Sponsor's protocol ID
- NIPMS-RV-KR-001
- Status last verified
- Nov 2017
- First submitted
- 21 Sep 2015
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVLIMID® Drug Use Examination
- ClinicalTrials.gov ID
- NCT02556905
- Acronym / sponsor ID
- NIPMS-RV-KR-001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Revlimid, Lenalidomide, Observational, Korea, Post Marketing Surveillance[PMS]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2011 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 22 Sep 2015 (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.
The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.
The patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.
Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.
REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug.
It is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean patients | – | Drug: REVLIMID®, Drug: DexamethasoneAll Korean patients intended to be treated with REVLIMID® according to the approved package insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Korean patients who are intended to be treated with REVLIMID® and must be registered in risk management program according to the approved package insert.
Key inclusion criteria (3 listed)
- Korean male or female who are diagnosed with Multiple Myeloma
- In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®
- Patients who are registered for Risk Management Program of Celgene
Key exclusion criteria (1 listed)
- There's no exclusion criteria
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 |
|---|---|---|
| REVLIMID®The recommended starting dose of REVLIMID® is 25mg/day with water orally administered as a single 25mg capsule on Days 1-21 of repeated 28-day cycles. Dose can be adjusted upon the clinical laboratory result. | Drug | Korean patients |
| DexamethasoneThe recommended dose of dexamethasone is 40mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the 4 cycle of therapy and then 40mg/day orally on Days 1-4 every 28 days. | Drug | Korean patients |
Primary outcome
Adverse events (AEs)
Time frame: Up to 6 years
Number of participants with adverse events
1 secondary outcome
Overall response rate
Time frame: Up to 6 years
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 4 Dec 2017.
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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.
Miran Moon study director
Celgene Korea
25 sites 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 Celgene at 25 sites 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 3 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 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 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 events (AEs) (time frame: Up to 6 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 4 Dec 2017.