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Non-interventional Study of L...

Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

389 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-17

Study Completion Date

2022-03-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lenalidomide Population

Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal

Lenalidomide

Intervention Type DRUG

Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Background Population

All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal

Lenalidomide

Intervention Type DRUG

Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Interventions

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Lenalidomide

Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Intervention Type DRUG

Other Intervention Names

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Revlimid CC-5013

Eligibility Criteria

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Inclusion Criteria

* Are ≥ 18 years old at the time of signing the Informed consent form (ICF)
* Are transfusion dependent or have an history of transfusion dependence; for the purpose of the current Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS), transfusion-dependence is defined as requiring ≥2 RBC units over an 8 week period prior to the date of signature on the ICF (due to MDS-related causes and not because of hemorrhage, trauma, or other acute cause)
* Are on active treatment with lenalidomide (Lenalidomide Cohort) or have never been exposed to lenalidomide at the time of signing the ICF (Background Cohort)
* Have confirmed diagnosis of IPSS low or intermediate-1-risk MDS with isolated del (5q) (with morphological and cytogenetic information) diagnosed on 15 June 2007 (date of Revlimid first approved in Europe) or later

Exclusion Criteria

* Refuse to participate in the Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS),
* Are currently participating in an interventional therapeutic clinical trial for MDS (except for erythropoiesis-stimulating agents \[ESAs\] and granulocyte colonystimulating growth factors)
* Receive any investigational agent the time of signing the ICF
* Have previously been treated with lenalidomide and are no longer on active treatment with lenalidomide at the time of signing the ICF

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Centre City, New Jersey, United States

Site Status