Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

389

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach

12 countries

148 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.3 years study duration

First Submitted

Initial submission to the registry

October 21, 2014

Completed

10 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

December 17, 2014

Completed

7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed

Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

7.3 years

First QC Date

October 21, 2014

Last Update Submit

August 18, 2022

Conditions

Myelodysplastic Syndrome

Keywords

LenalidomideRevlimidTransfusion-dependentinternational Prognostic Scoring System (IPSS) lowIntermediate-1-riskMDSIsolated del(5q)ProspectiveNon-interventionalPost-authorization safety study (PASS)Disease registry

Outcome Measures

Primary Outcomes (2)

Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid
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.
Up to 3 years
Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide
Number of MDS participants who survive
Up to 3 years

Secondary Outcomes (4)

Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide
Up to 3 years
Adverse Events
Up to 3 years
Evaluate risk factors associated with progression of AML
Up to 3 years
Clinical practice
Up to 3 years

Study Arms (2)

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

Drug: Lenalidomide

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

Drug: Lenalidomide

Interventions

LenalidomideDRUG

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

Also known as: Revlimid, CC-5013

Background PopulationLenalidomide Population

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients who have received at least 1 dose of any treatment or treatment modality after the patient signs the informed consent form * Lenalidomide cohort: All patients treated with lenalidomide * Background cohort: All patients treated with therapeutic modalities other than lenalidomide For each population 3 datasets will be described and will form the basis of subsequent analyses: * A baseline demographic dataset ("population dataset") * An exposure dataset * An outcome dataset

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Celgenelead

Study Sites (148)

Local Institution - 0001

Centre City, New Jersey, ZIP CODE, United States

Location

Local Institution - 0002

Centre City, New Jersey, ZIP CODE, United States

Location

Local Institution - Belgium