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NCT Number: NCT02279654

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 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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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Klina, Brasschaat, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lenalidomide

Drug

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

Other names: Revlimid, CC-5013

Primary outcomes

  1. 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

    Time frame: Up to 3 years

    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.

  2. Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide

    Time frame: Up to 3 years

    Number of MDS participants who survive

Secondary outcomes

  1. Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide

    Time frame: Up to 3 years

    Number of MDS participants who survive who have never been treated with Lenalidomide

  2. Adverse Events

    Time frame: Up to 3 years

    Type, frequency, severity of advere events and relationship of adverse events to Lenalidomide. An adverse ecent is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, ie, any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product

  3. Evaluate risk factors associated with progression of AML

    Time frame: Up to 3 years

    Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide

  4. Clinical practice

    Time frame: Up to 3 years

    Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients in MDS participants

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

Acronym: PASS MDS del5q

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2014
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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