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NCT02279654 · ClinicalTrials.gov registry record
Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
A clinical trial, sponsored by Celgene.
- Completed
- Registry status
- 389
- Enrollment target
NCT02279654: Completed study, sponsored by Celgene.
NCT02279654 is a clinical trial that has completed, run by Celgene. The registered enrollment target is 389 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02279654 has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- 389 participants
- Enrollment target
Study Summary
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 \[del(5q)\]. The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.
Primary Outcome
Incidence, as well as the attributable risk (AR) and AR percent (%). Progressive Disease criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2022-03-29 |
What the finished NCT02279654 record still lists
NCT02279654 is an observational study that tracks outcomes without assigning an intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT02279654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02279654 about?
NCT02279654 is a clinical study titled "Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)". This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 \[del(5q)\]. The purpose of this study is to ...
What is the current status of trial NCT02279654?
This trial is currently completed. The enrollment target is 389 participants. The study started on 2014-12-17. Estimated completion is 2022-03-29.
What interventions are being tested in trial NCT02279654?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT02279654?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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