Myelodysplastic SyndromesRevlimidPMSNCT04036448
A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea
An observational study of Myelodysplastic Syndromes and Lymphoma, Mantle-Cell, run by Celgene at 26 sites in South Korea.
Trial summary
The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea. This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Lymphoma, Mantle-Cell, Lymphoma, Follicular
- What is being tested?
- REVLIMID®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 28 participants
- Where
- 26 sitesSouth Korea
- Study dates
- 28 Nov 2019to 15 Aug 2023
- 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: Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted for IPSS low- or intermediate-1-risk del (5q) MDS, rrMCL and previously treated Follicular lymphoma.
Who may be able to join
- Treatment of patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality according to International scoring system for evaluating prognosis in myelodysplastic syndromes according to IPSS or
- Treatment of patients with mantle cell lymphoma who have received at least one prior therapy
- Previously treated follicular lymphoma (FL)
- Patients who are registered in Celgene Risk Management Program" in Korea
Who cannot join
- Pregnancy or females of childbearing potential
- Hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
- Patients with genetic disorder (e.g., galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
South Korea26 sites
Hallym University Medical Center
Anyang, 14068
Keimyung University Dongsan Hospital
Daegu, 41931
Kyungpook National University Hospital
Daegu, 41944
Local Institution - S03
Daegu, 700-712
Local Institution - S07
Daegu, 700-721
Local Institution - S11
Goyang, 411-719
CHONNAM National University Hwasun Hospital
Hwasun, 58128
Local Institution - S04
Hwasun-gun, 519-809
Naitonal Health Insurance Service Ilsan hospital
Ilsan, 10444
Gachon University Gil Mdical Center
Incheon, 21565
Local Institution - S09
Incheon, 21565
Jeonbuk National University Hospital
Jeonju, 54896
Local Institution - S10
Jeonju, 54907
Local Institution - S02
Seoul, Seoul Teugbyeolsi, 05505
Local Institution - S05
Seoul, 03080
Local Institution - S06
Seoul, 03080
Seoul National University Hospital
Seoul, 03080
Local Institution - S08
Seoul, 03722
Yonsei University Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Local Institution - S12
Seoul, 06351
Samsung Medical Center
Seoul, 06351
Local Institution - S01
Seoul, 06591
The Catholic University, St. Mary's Hospital
Seoul, 06591
Local Institution - S14
Wŏnju, 26426
Wonju Severance Christian Hospital
Wŏnju, 26426
About this study
Official title: Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea
The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea.
This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea.
Read more
Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below.
- Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del [5q] MDS)
- Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL)
- Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)
- Being tested
- REVLIMID®
- Keywords
- REVLIMID®, Lenalidomide, Observational, Korea, Post Marketing Surveillance[PMS], Relapsed and Refractory Mantle cell lymphoma, IPSS Low- or intermediate-1-risk Myelodysplastic Syndromes Associated with a deletion 5q, previously treated follicular lymphoma (FL) in Korea
- Medical subject headings
- Myelodysplastic Syndromes, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVLIMID®Drug
REVLIMID®
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide in IPSS Low-or intermediate-1-risk del population | For the IPSS Low- or intermediate-1-risk del (5q) (MDS), Lenalidomide treatment must not be started if the ANC < 0.5 x 109/L and/or platelet counts < 25 x 109/L. The recommended starting dose of lenalidomide is 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles. Receives: Drug: REVLIMID® | |
| Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population | For the Refractory/relapsed Mantle cell lymphoma (rrMCL), the recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. For the Follicular lymphoma (FL), the recommended starting dose of rituximab is 375 mg/m2 intravenously (IV) every week in Cycle 1 (days 1, 8, 15, and 22) and day 1 of every 28-day cycle for Cycles 2 through 5. Receives: Drug: REVLIMID® |
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 event
Measured: From enrollment until at least 28 days after completion of study treatment
Secondary outcomes (4)
Adverse events (AEs)
Number of participants with adverse events
Measured: From enrollment until at least 28 days after completion of study treatment
To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS
Effectiveness evaluation for IPSS low- or intermediate-1-risk del (5q) MDS is RBC transfusion-independence response rate for ≥ 56 days (8 weeks) in patients who receive at least 2 cycles of Revlimid
Measured: Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL
Effectiveness evaluation for refractory/relapsed Mantle Cell Lymphoma (rrMCL) is Overall Response Rate up to 6 cycles assessed by the investigators using the Cheson Criteria, 1999
Measured: Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL
Effectiveness evaluation for refractory/relapsed previously treated FL is Overall Response Rate up to 6 cycles assessed by the investigators per 2007 International Working Group criteria.
Measured: Up to 4 years of Revlimid treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start28 Nov 2019
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire (Myoung-Jin) Lee, Medical doctor, Study director, Celgene Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036448
- Sponsor's protocol ID
- CC-5013-MDS-013
- Other IDs
- U1111-1235-2858
- Acronym
- RevlimidPMS
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2019
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea
- ClinicalTrials.gov ID
- NCT04036448
- Acronym / sponsor ID
- RevlimidPMS / CC-5013-MDS-013
- Keywords
- REVLIMID®, Lenalidomide, Observational, Korea, Post Marketing Surveillance[PMS], Relapsed and Refractory Mantle cell lymphoma, IPSS Low- or intermediate-1-risk Myelodysplastic Syndromes Associated with a deletion 5q, previously treated follicular lymphoma (FL) in Korea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 29 Jul 2019 (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.
The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea.
This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea.
Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below.
- Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del [5q] MDS)
- Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL)
- Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide in IPSS Low-or intermediate-1-risk del population | – | Drug: REVLIMID®For the IPSS Low- or intermediate-1-risk del (5q) (MDS), Lenalidomide treatment must not be started if the ANC < 0.5 x 109/L and/or platelet counts < 25 x 109/L. The recommended starting dose of lenalidomide is 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles. |
| Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population | – | Drug: REVLIMID®For the Refractory/relapsed Mantle cell lymphoma (rrMCL), the recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. For the Follicular lymphoma (FL), the recommended starting dose of rituximab is 375 mg/m2 intravenously (IV) every week in Cycle 1 (days 1, 8, 15, and 22) and day 1 of every 28-day cycle for Cycles 2 through 5. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted for IPSS low- or intermediate-1-risk del (5q) MDS, rrMCL and previously treated Follicular lymphoma.
Key inclusion criteria (4 listed)
- Treatment of patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality according to International scoring system for evaluating prognosis in myelodysplastic syndromes according to IPSS or
- Treatment of patients with mantle cell lymphoma who have received at least one prior therapy
- Previously treated follicular lymphoma (FL)
- Patients who are registered in Celgene Risk Management Program" in Korea
Key exclusion criteria (3 listed)
- Pregnancy or females of childbearing potential
- Hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
- Patients with genetic disorder (e.g., galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
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®REVLIMID® | Drug | Lenalidomide in IPSS Low-or intermediate-1-risk del population, Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population |
Primary outcome
Adverse events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
Number of participants with adverse event
4 secondary outcomes
Adverse events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS
Time frame: Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL
Time frame: Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL
Time frame: Up to 4 years of Revlimid treatment period
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 11 Mar 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Related trials for Myelodysplastic Syndromes
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Claire (Myoung-Jin) Lee, Medical doctor study director
Celgene Korea
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Lymphoma, Mantle-Cell, run by Celgene at 26 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 4 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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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: From enrollment until at least 28 days after completion of study treatment). 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 11 Mar 2025.